Composition for the treatment of (pre)hypercholesterolemia and/or associated morbidities thereto

Description

The present invention relates to compositions and methods of treatment and/or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto. In particular, the present invention relates to compositions comprising at least two components selected from at least one human milk oligosaccharide (HMO), at least one C3-C4-alkane carboxylic acid, and at least one phytosterol.

Background of the invention

(Pre)hypercholesterolemia is a medical condition of a subject which is characterized by an abnormal and/or excessive increase of cholesterol levels in blood of said subject. A commonly used method for diagnosing (pre)hypercholesterolemia is measuring the total cholesterol level in blood.

Cholesterol is measured in milligrams per deciliter (mg/dl_) of blood in the United States and some other countries. In the United Kingdom, most European countries and Canada, millimoles per liter of blood (mmol/L) is the measure. For healthy adults, the UK National Health Service recommends upper limits of total cholesterol of 5 mmol/L, and low-density lipoprotein cholesterol (LDL) of 3 mmol/L. For people at high risk of cardiovascular disease, the recommended limit for total cholesterol is 4 mmol/L, and 2 mmol/L for LDL. In the United States, the National Heart, Lung, and Blood Institute within the National Institutes of Health classifies total cholesterol of less than 200 mg/dL as “desirable,” 200 to 239 mg/dL as “borderline high” (pre-hypercholesterolemia) and 240 mg/dL or more as “high” (hypercholesterolemia). No absolute cutoff between normal and abnormal cholesterol levels exists, and interpretation of values must be made in relation to other health conditions and risk factors.

Pre-hypercholesterolemia and hypercholesterolemia result when low-density lipoprotein receptors are unable to remove cholesterol from the blood effectively. Lipoproteins including very low-density lipoproteins (VLDL), intermediate-density lipoproteins (IDL), low-density lipoproteins (LDL) and high- density lipoproteins (HDL) are the carriers of cholesterol and cholesteryl esters in blood. All the lipoproteins carry cholesterol and cholesterol esters, but elevated levels of the lipoproteins other than HDL carrying cholesterol and cholesteryl esters (termed non-HDL cholesterol), particularly LDL- cholesterol, are associated with an increased risk of atherosclerosis and coronary heart disease.

High levels of total cholesterol in the blood typically result from a combination of genetic and environmental risk factors. Lifestyle choices including diet, exercise, and tobacco smoking strongly influence the amount of total cholesterol in the blood. Additional factors that impact total cholesterol levels include a person's gender, age, and health problems such as diabetes mellitus type 2, obesity, alcohol use, monoclonal gammopathy, dialysis therapy, nephrotic syndrome, hypothyroidism, Cushing’s syndrome and anorexia nervosa. Several medications and classes of medications may also interfere with lipid metabolism: thiazide diuretics, ciclosporin, glucocorticoids, beta blockers, retinoic acid, antipsychotics, certain anticonvulsants and medications for HIV as well as interferons.

A small percentage of all people with high total cholesterol levels in blood have an inherited form of hypercholesterolemia. The most common cause of inherited high total cholesterol is a condition known as familial hypercholesterolemia, which results from mutations in the LDLR gene. Less commonly, hypercholesterolemia can be caused by mutations in the APOB, LDLRAP1 or PCSK9 gene. Mutations in any of these genes prevent the cell from making functional receptors or alter the receptors' function.

Cholesterol belongs to the chemical class of sterol. Cholesterol and its derivatives are structural components of cell membranes (essential to maintain membrane structure, fluidity and function), and precursors of steroid hormones, bile acid and vitamin D. Cholesterol is synthesized in all cells of the human body. A human male weighing 68 kg normally synthesizes about 1 gram of cholesterol per day, and his body contains about 35 g, mostly contained within the cell membranes. Cholesterol is contained in the human diet in animal-derived foods like meat, dairy and eggs. Typical daily cholesterol dietary intake for a man in the United States is 307 mg. The body also compensates for absorption of ingested cholesterol by reducing its own cholesterol synthesis. Biosynthesis of cholesterol is directly regulated by the cholesterol levels present, though the homeostatic mechanisms involved are only partly understood. A higher intake from food leads to a net decrease in endogenous production, whereas lower intake from food has the opposite effect. The main regulatory mechanism is the sensing of intracellular cholesterol in the endoplasmic reticulum by the protein SREBP (sterol regulatory element-binding protein 1 and 2).

Two major factors involved in cholesterol homeostasis are the LDL receptor that scavenges circulating LDL from the bloodstream, and HMG-CoA reductase which leads to an increase of endogenous production of cholesterol.

In addition, cholesterol is recycled in the human body. The liver excretes it in a non-esterified form (via bile) into the digestive tract. Typically, about 50% of the excreted cholesterol is reabsorbed by the small intestine back into the bloodstream. This reabsorption can be reduced with phytosterols. Phytosterols also belong to the chemical class of sterols and show some similarities to cholesterol. Based thereupon phytosterols can compete with cholesterol for reabsorption in the intestinal tract, thus potentially reducing cholesterol reabsorption. When intestinal lining cells absorb phytosterols, in place of cholesterol, they usually excrete the phytosterol molecules back into the gastro-intestinal tract, an important protective mechanism.

As the excess cholesterol circulates through the bloodstream, it is deposited abnormally in tissues such as the skin, tendons, eyes, and veins, e.g. in the arteries that supply blood to the heart.

(Pre)hypercholesterolemia itself is asymptomatic. Chronic hypercholesterolemia over a period of decades contributes to the formation of atheromatous plaques in the arteries, which leads to atherosclerosis, a process, which includes progressive arterial occlusion, stenosis and blockage of blood supply to tissues and organs. Gradual stenosis and blockage manifest as symptoms typical of chronic ischemia and impaired organ function or sudden failure. Alternatively, smaller plaques may rupture and cause acute obstruction of blood flow leading to acute, transient ischemic attack (brain), transient chest pain (heart), transient visual loss (eye), transient leg pain (leg), transient abdominal pain (intestines), ischemia and impaired organ function or failures, e.g. heart attack, stroke, peripheral thrombosis.

Some types of (pre)hypercholesterolemia lead to specific physical findings. For example, familial hypercholesterolemia (Type lla hyperlipoproteinemia) may be associated with xanthelasma palpebrarum (yellowish patches underneath the skin around the eyelids), arcus senilis (white or gray discoloration of the peripheral cornea), and xanthomata (deposition of yellowish cholesterol-rich material) of the tendons, especially of the fingers. Type III hyperlipidemia may be associated with xanthomata of the palms, knees and elbows.

(Pre)hypercholesterolemia is often linked with a number of conditions and/or diseases of the cardiovascular system, the abdomen, the brain & nerves, the lungs, the eyes, the skin and the tendons (see Table 1).

Table 1 :

According to the US National Library of Medicine, more than 34 million American adults have elevated total cholesterol levels of the blood (higher than 240 mg/dL). The WHO stated that raised cholesterol is estimated to cause annually worldwide 2.6 million deaths (4.5% of total) and 29.7 million disability adjusted life years (DALYS). Raised total cholesterol is a major cause of disease burden in both the developed and developing world as a risk factor for ischemic heart disease and stroke. A 10% reduction in total cholesterol in the serum of men aged 40 has been reported to result in a 50% reduction in heart disease within 5 years; the same serum cholesterol reduction for men aged 70 years can result in an average 20% reduction in heart disease occurrence in the next 5 years.

For the treatment or prevention of (pre)hypercholesterolemia lifestyle changes are recommended including smoking cessation, limiting alcohol consumption, increasing physical activity, and maintaining a healthy weight. Dietary changes are recommended, e.g. avoiding trans fats and replacing saturated fats in adult diets with polyunsaturated fats to reduce total blood cholesterol and LDL in adults. In people with very high cholesterol (e.g., familial hypercholesterolemia), diet is often not sufficient to achieve the desired lowering of LDL, and lipid-lowering medications (statins, fibrates, nicotinic acid, cholestyramine) are usually required. If necessary, other treatments such as LDL apheresis, antibody therapy (evolocumab, bococizumab, alirocumab) or even surgery are performed.

As the case may be certain medication is available for morbidities associated to (pre)hypercholesterolemia depending on the specific indication.

Notwithstanding the foregoing, there is still an urgent need for compositions being suitable in the treatment and/or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto. Summary of the invention

Accordingly, the present invention provides in a first aspect a composition I comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol; or a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof; or a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO.

Another aspect of the present invention relates to said compositions I, II or III for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto. Another aspect of the present invention relates to said compositions I, II or III for use in the treatment or prevention of (pre)hypercholesterolemia, in particular pre-hypercholesterolemia or hypercholesterolemia. Another aspect of the present invention relates to said compositions I, II or III for use in the treatment or prevention of morbidities associated to (pre)hypercholesterolemia.

In another aspect the present invention relates to methods for treating a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities. In another aspect the present invention relates to methods for treating a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia, in particular prehypercholesterolemia or hypercholesterolemia. In another aspect the present invention relates to methods for treating a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In a further aspect the present invention relates to a nutritional supplement or a functional food comprising said compositions I, II or III.

Another aspect of the present invention is related to the use of said composition as a nutritional supplement or a functional food, in particular in the dietary management of (pre)hypercholesterolemia and/or associated morbidities. Another aspect of the present invention is related to the use of said compositions I, II or III as a nutritional supplement or a functional food, in particular in the dietary management of (pre)hypercholesterolemia, in particular of prehypercholesterolemia or hypercholesterolemia. Another aspect of the present invention is related to the use of said composition I, II or III as a nutritional supplement or a functional food, in particular in the dietary management of morbidities associated to (pre)hypercholesterolemia.

In a further aspect the present invention relates to a kit for the pharmaceutical use or dietary management use comprising individually the components of said compositions I, II or III, respectively.

Detailed description of the invention

It has now been found that HMOs can be combined with C3-C4-alkane carboxylic acids or derivatives thereof, and optionally with at least one phytosterol. Such compositions provide beneficial effects as described herein.

The present invention provides composition I. The composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol.

For the purpose of the present invention, the term “HMO" refers to human milk oligosaccharide(s). These carbohydrates are resistant to enzymatic hydrolysis by digestive enzymes (e.g. pancreatic and/or brush border). In the human breast milk many different kinds of HMOs are found. Each individual HMO is based on a combination of glucose, galactose, sialic acid (N-acetylneuraminic acid), fucose and/or N-acetylglucosamine with many and varied linkages between them. So far over 130 such structures have been identified in human milk. Almost all of them have a lactose moiety at their reducing end while sialic acid and/or fucose (when present) occupy terminal positions at the non-reducing ends. The HMOs can be acidic (e.g. charged sialic acid containing oligosaccharide) or neutral (e.g. fucosylated oligosaccharide).

In an embodiment of the present invention the HMO is selected from the group of fucosylated oligosaccharides, N-acetylated oligosaccharides and sialylated oligosaccharides.

In an embodiment of the present invention the HMO is a "fucosylated oligosaccharide". These are HMOs having a fucose residue. It has a neutral nature. Some examples are 2'-FL (2'-fucosyllactose), 3-FL (3-fucosyllactose), difucosyllactose, lacto-N-fucopentaose (e.g. lacto-N- fucopentaose I, lacto- N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V), lacto-N-fucohexaose, lacto-N- difucohexaose I, fucosyllacto-N-hexaose, fucosyllacto- N-neohexaose, difucosyllacto-N-hexaose I, difucosyllacto-N-neohexaose II and any combination thereof. In a preferred embodiment the fucosylated oligosaccharide is selected from the group comprising 2’-FL, 3-FL and difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL). In particular, the fucosylated oligosaccharide is 2’-FL.

In another embodiment of the present invention the HMO is a ”N-acetylated oligosaccharide”. The term ”N-acetylated oligosaccharide(s)” encompasses both "N-acetyl-lactosamine" and "oligosaccharide(s) containing N-acetyl-lactosamine". They are neutral oligosaccharides having an N-acetyl-lactosamine residue. Suitable examples are LNT (lacto-N-tetraose), para-lacto-N- neohexaose (para-LNnH), LNnT (lacto-N-neotetraose) or any combination thereof. Other examples are lacto-N-hexaose, lacto-N-neohexaose, para-lacto-N-hexaose, para-lacto-N-neohexaose, lacto- N-octaose, lacto-N- neooctaose, iso- lacto-N-octaose, para- lacto-N-octaose and lacto-N-decaose or any combination thereof. In a preferred embodiment the N-acetylated oligosaccharide is selected from the group of LNT and LNnT.

In another embodiment of the present invention the HMO is a ’’sialylated oligosaccharide". The term ’’sialylated oligosaccharide” encompasses an oligosaccharide having a sialic acid residue. It has an acidic nature. Some examples are 3’-SL (3'-sialyllactose) and 6’-SL (6'-sialyllactose). In a preferred embodiment the sialylated oligosaccharide is 6’-SL.

In another embodiment the HMO is selected from the group comprising 2’-FL, 3-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL and/or any combination thereof. In particular, the HMO is selected from the group comprising 2’-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3,2’-DiFL), LNT, LNnT and 6’-SL and/or any combination thereof. Especially the HMO is selected from the group comprising 2’-FL, LNT, LNnT and 6'-SL and/or any combination thereof.

For the purpose of the present invention, the term “C3-C4-alkane carboxylic acid or derivative thereof’ encompasses propionic acid, n-butyric acid and iso-butyric acid (2-methyl propionic acid) as well as derivatives thereof and/or any mixture thereof. Suitable derivatives are salts, esters and amides, in particular physiologically acceptable ones.

Examples for physiologically acceptable salts are alkali salts, like sodium or potassium salts, or alkaline-earth salts, like magnesium or calcium salts, or choline salts. Preferably the physiologically acceptable salts are alkali salts, in particular sodium salts or potassium salts, especially sodium salts.

Examples for physiologically acceptable esters are those derived from C1-C6 alcohols, in particular those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or dihydric C1-C6 alcohols, like those derived from 1 ,2-ethandiol, or C1-C4 alkoxy substituted monohydric alcohols, like those derived from 2-methoxyethanol, 2-ethoxyethanol or 2-butoxyethanol. Other examples for physiologically acceptable esters are glycerides, like mono-, di-, or triglycerides, in particular mono- or diglycerides. Preferably the physiologically acceptable esters are those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or mono- or diglycerides.

Examples for physiologically acceptable amides are those derived from mono- or di-C1-C6-alkyl amines.

In an embodiment of the present invention the C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid (= free propionic acid) or butyric acid (= free butyric acid) or a mixture thereof.

In another embodiment the C3-C4 alkane carboxylic acid is provided as physiologically acceptable derivative thereof; in particular the derivative is a physiologically acceptable salt, e.g. a sodium salt or potassium salt, or a mixture thereof, or a physiologically acceptable ester, e.g. said ester is derived from C1 -C6 alcohols, in particular a mono-or a dihydric C1 -C6 alcohol, or said ester is a mono- or diglyceride, or a mixture thereof.

In a further embodiment the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate or sodium butyrate or potassium butyrate or a mixture thereof. Especially, it is sodium propionate or sodium butyrate or a mixture thereof.

In a further embodiment the C3-C4-alkane carboxylic acid or derivative thereof is propionic acid or a derivative thereof, in particular it is a physiologically acceptable salt of propionic acid, especially it is sodium propionate or potassium propionate, or a physiologically acceptable ester of propionic acid, especially methyl propionate or ethyl propionate or propionic acid monoglyceride or propionic acid diglyceride, particularly ethyl propionate or propionic acid monoglyceride. In a particular embodiment the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate.

In a further embodiment the C3-C4-alkane carboxylic acid or derivative thereof is butyric acid or a derivative thereof, in particular it is a physiologically acceptable salt of butyric acid, especially it is sodium butyrate or potassium butyrate, or a physiologically acceptable ester of butyric acid, especially methyl butyrate or ethyl butyrate or butyric acid monoglyceride or butyric acid diglyceride, particularly ethyl butyrate or butyric acid monoglyceride. In a particular embodiment the C3-C4- alkane carboxylic acid or derivative thereof is sodium butyrate or potassium butyrate. In a further embodiment the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of propionic acid and butyric acid or derivatives thereof, in particular it is a mixture of physiologically acceptable salts of propionic acid and butyric acid, especially it is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate, or a mixture of physiologically acceptable esters of propionic acid and butyric acid, especially a mixture of methyl propionate and methyl butyrate, or a mixture of ethyl propionate and ethyl butyrate, or a mixture of propionic acid monoglyceride and butyric acid monoglyceride, or a mixture of propionic acid diglyceride and butyric acid diglyceride, particularly a mixture of ethyl propionate and ethyl butyrate or a mixture of propionic acid monoglyceride and butyric acid monoglyceride. In a particular embodiment the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate.

For the purpose of this invention, the term “phytosterol” relates to at least one plant sterol or plant stand, being present in the free form and/or in the ester form. Examples for plant sterols are sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7- stigmasterol, and the like, and examples for plant stands are sitostanol, in particular beta-sitostanol, campestanol, , stigmastanol, brassicastanol, D5-avenastanol, D7-stigmastanol, and the like. In one embodiment they can be present in the form of esters, in particular they are fatty acid esters. Said fatty acids are usually obtained from vegetable oils, like soy-bean oil, rape oil and the like. In another embodiment the plant sterol or plant stand can be present in free form. Also, mixtures of the free form and the ester form are possible. Unless otherwise specified in the present application, the terms “phytosterol”, “plant sterol”, “plant stand” as well the individual examples mentioned above relate to the respective free form, or the ester form or mixtures thereof.

In a preferred embodiment the at least one phytosterol is a mixture of two or more phytosterols, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or in another embodiment preferably a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or in another embodiment preferably a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment the at least one phytosterol is derived from vegetable sources, in particular it comprises 40 to 60 weight percent equivalent sitosterol, especially beta-sitosterol, and 10 to 40 weight percent equivalent campesterol. Within this application weight percentage equivalent refer to the weight contribution of the sterol/stanol backbone only, that means that in case the phytosterol is present in ester form the weight contribution of the ester moiety is not counted. The contribution of all sterol/stanol backbones present sums up to 100% weight percent equivalents. In another embodiment the at least one phytosterol derived from vegetable sources comprises 40 to 60 weight percent equivalent sitosterol, especially beta-sitosterol, 10 to 40 weight percent equivalent campesterol and 10 to 30 weight percent equivalent stigmasterol, or it comprises 40 to 60 weight percent equivalent sitosterol, especially beta-sitosterol, 10 to 40 weight percent equivalent campesterol and 0.1 to 3.0 weight percent equivalent stigmasterol.

In another embodiment the at least one phytosterol is derived from wood sources, e.g. from pine, in particular it comprises 45 to 80, especially 65 to 80, weight percent equivalent sitosterol, especially beta-sitosterol, and 3 to 25 weight percent equivalent campesterol. In another embodiment the at least one phytosterol derived from wood sources comprises 45 to 80, especially 65 to 80, weight percent equivalent sitosterol, especially beta-sitosterol, 3 to 25 weight percent equivalent campesterol and 0 to 2 weight percent equivalent stigmasterol, or it comprises 45 to 80, especially 65 to 80, weight percent equivalent sitosterol, especially beta-sitosterol, 3 to 25 weight percent equivalent campesterol and 10 to 20 weight percent equivalent sitostanol, especially beta-sitostanol.

In an embodiment of the present invention the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

In an embodiment of the present invention the composition I does not comprise one or more phytosterols.

In another embodiment of the present invention the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol.

In another embodiment of the present invention the composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In an embodiment of the present invention the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol, wherein the ratio of the at least one HMO (component A) and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) is from 100:1 to 1 :100, preferably from 20:1 to 1 :20, more preferably 10:1 to 1 :10, even more preferably from 3:1 to 1 :3, in particular2:1 to 1 :2.

In another embodiment of the present invention the composition I comprises as at least one C3-C4- alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100:1 to 1 :100, preferably from 20:1 to 1 :20, more preferably from 10:1 to 1 :15, even more preferably from 2:1 to 1 :8.

In another embodiment of the present invention the at least one HMO and the at least one C3-C4- alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.

In an embodiment of the present invention said composition I does not comprise one or more phytosterols.

In an embodiment of the present invention the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol, wherein the ratio of the at least one HMO (component A) and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) is from 100:1 to 1 : 100, preferably from 20:1 to 1 :20, more preferably 10:1 to 1 :10, even more preferably from 3:1 to 1 :3, in particular2:1 to 1 :2, and/or wherein the ratio of the at least one HMO (component A) and the at least one phytosterol (component C) is from 50:1 to 1 :100, preferably from 25:1 to 1 :50, even more preferably from 20:1 to 1 :30, and/or wherein the ratio of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) and the at least one phytosterol (component C) is from 10:1 to 1 : 100, preferably 5:1 to 1 :50, even more preferably 2:1 to 1 :10. In another embodiment of the present invention said composition I comprises as at least one C3-C4- alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100:1 to 1 : 100, preferably from 20:1 to 1 :20, more preferably from 10:1 to 1 :15, even more preferably from 2:1 to 1 :8.

In another embodiment of the present invention the at least one HMO and the at least one C3-C4- alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.

In another embodiment of the present invention the at least one HMO and the at least one the phytosterol are present in synergistic amounts.

In another embodiment of the present invention the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol are present in synergistic amounts.

In another embodiment of the present invention the at least one HMO, the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol are present in synergistic amounts.

In another embodiment of the present invention the total amount of the at least one HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally the at least one phytosterol is from 1 to 100 wt% of the total composition I, preferably from 10 to 100 wt%.

In another embodiment the total amount of the at least one HMO is from 0.5 to 95 wt% of the total composition I, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%. In yet another embodiment the total amount of the at least one HMO is from 0.5 to 50 wt% of the total composition I, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%. In yet another embodiment the total amount of the at least one HMO is from 50 to 95 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

In another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 95 wt% of the total composition I, preferably from 10 to 90 wt%, more preferably from 15 to 85 wt%, even more preferably from 20 to 75 wt%, in particular from 25 to 60 wt%. In yet another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 50 wt% of the total composition I, preferably from 10 to 45 wt%, more preferably from 15 to 35 wt%. In yet another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 95 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%. In another embodiment the total amount of the at least one phytosterol is from 1.0 to 95 wt% of the total composition I, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%. In yet another embodiment the total amount of the at least one phytosterol is from 0.5 to 50 wt% of the total composition I, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%. In yet another embodiment the total amount of the at least one phytosterol is from 50 to 95 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

In another embodiment of the present invention the composition I can further comprise one or more vitamins or related compounds thereto. Examples of vitamins and related compounds thereto include vitamin A (e.g. retinol, retinyl acetate, retinyl palmitate, retinyl stearate, retinyl esters with other long-chain unsaturated fatty acids, retinal, retinoic acid and the like), vitamin B1 (e.g. thiamine, thiamine pyrophosphate, TPP, thiamine triphosphate, TTP, thiamine hydrochloride, thiamine mononitrate and the like), vitamin B2 (e.g. riboflavine, flavine mononucleotide (FMN), flavine adenine dinucleotide (FAD), lactoflavine, ovoflavine and the like), vitamin B3 (e.g. nicotinic acid, nicotinamide, nicotinamide adenine dinucleotide (NAD), nicotinic acid mononucleotide (NicMN), pyridine-3-carboxylic acid and the like, as well as the vitamin B3-precursor tryptophan), pantothenic acid (e.g. pantothenate, panthenol and the like), vitamin B6 (e.g. pyridoxine, pyridoxal, pyridoxamine, pyridoxine hydrochloride and the like), biotin, folic acid (e.g. folate, folacin, pteroylglutamic acid and the like), vitamin B12 (e.g. cobalamin, methylcobalamin. deoxyadenosyl- cobalamin, cyanocobalamin, hydroxycobalamin, adenosylcobalamin and the like), vitamin E (e.g. alpha-, beta-, gamma- and/or delta-tocopherol, alpha-, beta-, gamma- and/or delta-tocopherol acetate, alpha-, beta-, gamma- and/or delta-tocopherol succinate, alpha-, beta-, gamma- and/or delta-tocopherol nicotinate, alpha-, beta-, gamma- and/or delta tocotrienol and the like), vitamin K (e.g. vitamin K1 , phylloquinone, naphthoquinone, vitamin K2, menaquinone-7, vitamin K3, menaquinone-4, menadione, menaquinone-8, menaquinone-9, menaquinone-10, menaquinone-11 , menaquinone-12, menaquinone-13, and the like ), vitamin C (ascorbic acid), vitamin D (e.g. calciferol, cholecalciferol, 1 ,25-dihydroxyvitamin D, ergocalciferol and the like), and the like and/or mixtures thereof.

The presence and amounts of specific vitamins and/or related compounds thereto will vary depending on the intended use.

In a specific embodiment composition I does not comprise one or more phytosterols.

In a specific embodiment composition I does comprise one or more phytosterols. In another embodiment of the present invention the composition does not comprise one or more vitamins or related compounds thereto.

In another embodiment of the present invention the composition I can further comprise one or more carotenoids. Examples of carotenoids include astaxanthin, alpha-carotene, beta-carotene, beta- cryptoxanthin, lutein, lycopene, meso-zeaxanthin, zeaxanthin and the like (including cis/trans isomers) and/or mixtures thereof. The presence and amounts of specific carotenoids will vary depending on the intended use.

In a specific embodiment composition I does not comprise one or more phytosterols.

In a specific embodiment composition I does comprise one or more phytosterols.

In another embodiment of the present invention the composition I does not comprise one or more carotenoids.

In another embodiment of the present invention the composition I can further comprise one or more medium-chain fatty acids. These medium-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or alkyl esters. Examples of medium-chain fatty acids include caproic acid, caprylic acid, capric acid, lauric acid and the like and /or mixtures thereof.

The presence and amounts of specific medium chain fatty acids will vary depending on the intended use.

In a specific embodiment composition I does not comprise one or more phytosterols.

In a specific embodiment composition I does comprise one or more phytosterols.

In another embodiment of the present invention the composition I does not comprise one or more medium-chain fatty acids.

In another embodiment of the present invention the composition I can further comprise one or more long-chain fatty acids. These long-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or as alkyl esters. Examples of long chain fatty acids include saturated long chain fatty acids (e.g. myristic acid, palmitic acid, stearic acid, arachidic acid, behenic acid, lignoceric acid, cerotic acid and the like and/or mixtures thereof), mono-unsaturated long chain fatty acids (e.g. myristoleic acid, palmitoleic acid, sapienic acid, oleic acid, elaidic acid, vaccenic acid, erucic acid and the like and/or mixtures thereof), polyunsaturated long chain fatty acids (e.g. linoleic acid, linoelaidic acid, alpha-linolenic acid, arachidonic acid, eicosapentaenoic acid, docosapentenoic acid, docosahexaenoic acid and the like and/or mixtures thereof) and/or mixtures thereof. These long chain fatty acids are comprised for example in vegetable oils, single cell oils and marine oils, e.g. fish oil, krill oil and the like.

The presence and amounts of specific long chain fatty acids will vary depending on the intended use.

In a specific embodiment composition I does not comprise one or more phytosterols.

In a specific embodiment composition I does comprise one or more phytosterols.

In another embodiment of the present invention the composition I does not comprise one or more long-chain fatty acids.

In another embodiment of the present invention the composition I can further comprise one or more prebiotics. Examples of prebiotics include water-insoluble fibers (e.g. lignin, cellulose, hemi- cellulose, resistant starch, xanthum gum and the like and/or mixtures thereof), water-soluble fibers (e.g. arabinoxylan, inulin, pectin, alginic acid and derivatives thereof, agar, carrageen, raffinose, xylose, polydextrose, lactulose, and the like and/or mixtures thereof), other oligosaccharides like xylooligosaccharides, fructooligosaccharides, galactooligosaccharides, isomalto-oligosaccharides and the like and/or mixtures thereof.

The presence and amounts of specific prebiotics will vary depending on the intended use.

In a specific embodiment composition I does not comprise one or more phytosterols.

In a specific embodiment composition I does comprise one or more phytosterols.

In another embodiment of the present invention the composition I does not comprise one or more prebiotics.

In another embodiment of the present invention the composition I can further comprise one or more probiotics. Examples of probiotics optionally present in the composition I of the present invention include microorganisms or parts thereof of the family Lactobacillaceae, e.g. of the genus Lacto bacillus (e.g. the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii (like lactobacillus delbrueckii spp. bulgaricus, lactobacillus delbrueckii spp. delbrueckii, lactobacillus delbrueckii spp. lactis), lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus rhamnosus, lactobacillus salivarius and the like), of the genus Bifidobacterium (e.g. the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum and the like), of the genus Pediococcus (e.g. the species pediococcus acidilactici, pediococcus pentosaceus and the like), of the genus Lactococcus (e.g. the species lactococcus lactis (like lactococcus latis spp. cremoris, lactococcus lactis spp. lactic and the like) and of the genus Streptococcus (e.g. the species streptococcus thermophilus and the like) and of the genus Faecalibacterium (e.g. the species faecalibacterium prausnitzii) and of the genus Bacillus (e.g. the species bacillus subtilis) and the like and/or mixtures thereof.

The presence and amounts of specific probiotics will vary depending on the intended use.

In a specific embodiment composition I does not comprise one or more phytosterols.

In a specific embodiment composition I does comprise one or more phytosterols.

In another embodiment of the present invention the composition I does not comprise one or more probiotics.

In another embodiment of the present invention the composition I can further comprise one or more phenolic compounds. Examples of phenolic compounds include monophenols (e.g. apiole, carnosol, carvacrol, dillapiole, rosemarinol and the like), flavonoids (e.g. quercetin, kaempferol, myricetin, fisetin, rutin, isorhamnetin, hesperidin, naringenin, silybin, eriodyctiol, acacetin, apigenin, chrysin, diosmetin, tangeritin, luteolin, catechins like epigallocatechin gallate, theaflavin, thearubigins, proanthocyanidins, pelargonidin, peonidin, cyanidin, delphinidin, malvidin, petunidin and the like), isoflavonoids (e.g. daidzein, genistein, glycitein and the like), aurones, chalconoids, flavonolignans, lignans, phytoestrogens, stilbenoids (e.g. resveratrol, pterostilbene, piceatannol and the like), curcuminoids (e.g. curcumin and the like), tannins, aromatic acids (e.g. salicylic acid, vanillic acid, gallic acid, ellagic acid, tannic acid, caffeic acid, chlorogenic acid, cinnamic acid, ferulic acid, coumarin and the like), phenylethanoids (e.g. tyrosol, hydroxytyrosol, oleocanthal, oleuropein and the like ), capsaicin, gingerol, alkylresorcinol and the like and/or mixtures thereof.

The presence and amounts of specific phenolic compounds will vary depending on the intended use.

In a specific embodiment composition I does not comprise one or more phytosterols.

In a specific embodiment composition I does comprise one or more phytosterols. In another embodiment of the present invention the composition I does not comprise one or more phenolic compounds.

In another embodiment of the present invention the composition I can further comprise one or more herbals, e.g. known from Chinese diets, Indian diets, Mediterranean diets and the like. These herbals can be provided as powders obtained from the plant and/or fungus or parts thereof or as extracts thereof.

Examples for herbals known from Chinese diets include extracts or powders of hawthorn fruit, wolfberry, spatholobus stem, caterpillar fungus, cloud mushroom, crysanthemum, honeysuckle flower, mulberry leaf, glossy privet fruit, malaytea scurfpea fruit, cherokee rose fruit, palmleaf raspberry fruit, Chinese magnoliavine fruit, reishi mushroom, ephedra, epimedium, Angelica root, Astragalus root, rhubarb, licorice, morinda root, notoginseng, white peony root, American ginseng, fleeceflower root, kudzu root, rehmannia root, salvia root, Chinese yam, wild buckwheat rhizome, tall gastrodia tuber, golden root, Cassia seed, Coix seed, Dodder seed and the like and/or mixtures thereof.

Examples for herbals known from Indian diets include extracts or powders of Amalaki (Indian gooseberry), Haritaki (chebulic myrobalan), Bibhitaki (beleric), Haldi (turmeric), Tulsi (holy basil), Shigru (moringa), Twak (cinnamon), Yashtimadhu (licorice root), Dhanyaka (coriander), Ashwagandha (winter cherry), Kumkuma (saffron), Manjistha (Indian madder), Brahmi (bacopa), Neem (margosa), Ajwain (Bishop’s weed), Elaichi (cardamom), Shikakai (Acacia concinna), Shatavari (wild asparagus), Jeera (cumin), Guduchi (tinospora) and the like and/or mixtures thereof. Examples for herbals known from Mediterranean diets include extracts or powders of rosemary, basil, parsley, saffron, thyme, oregano, sage, cilantro, lemon, orange, grape, grapeseed, fig, blueberry, raspberry, strawberry, cherry, fennel, sesame seeds, pine seeds, garlic, onion, ginger root, pepper, chili and the like, olive oil and/or mixtures thereof.

The presence and amounts of specific herbals will vary depending on the intended use.

In a specific embodiment composition I does not comprise one or more phytosterols.

In a specific embodiment composition I does comprise one or more phytosterols.

In another embodiment of the present invention the composition I does not comprise one or more herbals.

In another embodiment of the present invention the composition I can further comprise one or more minerals. Examples of minerals include such ones comprising calcium, phosphorous, iodine, iron, magnesium, copper, zinc, manganese, chlorine, potassium, sodium, selenium, chromium, molybdenum and the like and/or mixtures thereof. In an embodiment of the present invention the mineral does not comprise iron. Minerals are usually added in salt form.

The presence and amounts of specific minerals will vary depending on the intended use.

In a specific embodiment composition I does not comprise one or more phytosterols.

In a specific embodiment composition I does comprise one or more phytosterols.

In another embodiment of the present invention the composition I does not comprise one or more minerals.

In another embodiment of the present invention the composition I does not comprise one or more antibodies.

The compositions I of the present invention can be prepared by mixing the at least one HMO, and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, optionally the at least one phytosterol, and optionally further components e.g. vitamins and related compounds thereto, carotenoids, medium chain fatty acids, long chain fatty acids, prebiotics, probiotics, phenolic compounds, herbals, minerals and the like and/or mixtures thereof, as known in the art. In an embodiment thereof the composition I does not comprise more than 80 wt% water.

Furthermore, the present invention provides a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol, for use as a medicament, preferably as a medicament for mammals and/or birds, in particular as a medicament for mammals.

For the purpose of the present invention, the term ’’mammals” encompasses humans and nonhuman mammals. Examples for non-human mammals are livestock, e.g. sheep, goats, pigs, cattles, horses, camels, llamas and the like, and pets, e.g. cats, dogs and the like.

In a preferred embodiment of the present invention the composition I is for use as a medicament for humans.

In another preferred embodiment of the present invention the composition I is for use as a medicament for livestock and/or pets. In another preferred embodiment of the present invention the composition I is for use as a medicament for birds, e.g. poultry (like chickens, ducks, geese, turkeys and the like) and ornamental birds (like canaries and the like).

The compositions I of the present invention for use as a medicament can be administered orally, enterally or parenterally, preferably orally.

In an embodiment of the present invention the composition I for use as a medicament is an orally administrable composition.

In another embodiment of the present invention the composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and optionally iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for use as a medicament, preferably as a medicament for humans.

It is understood that the embodiments mentioned for the composition I shall be applicable for the compositions I for use as a medicament and the specific embodiments thereto.

Furthermore, the present invention provides a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol, for the use in the treatment and/or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, preferably of mammals, more preferably of humans.

For the purpose of the present invention the term ’’treatment” in the context of (pre)hyper- cholesterolemia and/or associated morbidities thereto means using an effective therapy or management to alleviate, reduce or cure the condition and/or disease ((pre)hypercholesterolemia and/or associated morbidities thereto) and/or symptoms thereof, as the case may be, in addition it also includes the stabilization of the condition and/or disease, as the case may be, in order not to worsen in the course of the respective condition and/or disease. In an embodiment of the present invention treatment is understood as using an effective therapy or management to stabilize, alleviate or reduce the condition and/or disease and/or symptoms thereof, as the case may be.

Within the context of the present invention the term ’’prevention” in the context of (pre)hypercholesterolemia and/or associated morbidities thereto means an effective therapy or management so that the condition and/or disease ((pre)hypercholesterolemia and/or associated morbidities thereto) does not de novo develop, manifest and/or symptoms thereof do not occur.

In an embodiment of the present invention the composition I is for use in the treatment of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention the composition I is for use in the prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

For the purpose of the present invention the term ’’(pre)hypercholesterolemia” refers to a condition and/or disease, as the case may be, which is characterized by an abnormal and/or excessive increase of the level of total cholesterol in blood of a respective subject. In particular, a subject is considered as (pre)hypercholesterolemic in case the subject has pre-hypercholesterolemia or hypercholesterolemia, e.g with a level of total cholesterol in blood of 200 mg/ml_ or more.

Wthin the context of the present invention the term “pre-hypercholesterolemia” refers to a condition or disease wherein the respective subject shows a level of total cholesterol in the blood of 200 to 239 mg/dl_ and the term “hypercholesterolemia” refers to a condition or disease wherein the respective subject shows a level of total cholesterol in the blood of 240 mg/dl_ or more.

In an embodiment of the present invention the composition I is for use in the treatment or prevention of pre-hypercholesterolemia of a human.

In an embodiment of the present invention the composition I is for use in the treatment or prevention of hypercholesterolemia of a human.

For the purpose of the present invention the term “associated morbidities” as well as the term ’’morbidities associated to” mean one or more conditions and/or diseases which are co-occurring to the primary condition or disease ((pre)hypercholesterolemia), or which are occurring later in the life of the subject who had earlier in his or her life said primary condition and/or disease ((pre)hypercholesterolemia). In another embodiment of the present invention the composition I is for use in the treatment or prevention of an associated morbidity, e.g. an associated morbidity of the cardiovascular system, which includes atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure, deep vein thrombosis etc., an associated morbidity of the abdomen, which includes transient ischemic attack (which manifests as abdominal pain), intestinal embolism, renal failure etc., an associated morbidity of the brain and/or nerves, which includes transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure, stroke etc., an associated morbidity of the lungs, which includes transient ischemic attack (which manifests as chest pain), pulmonary embolism, respiratory failure etc. an associated morbidity of the eyes, which includes arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism, visual failure etc., an associated morbidity of the skin, which includes xanthelasma palpebarum etc., an associated morbidity of the tendons, which includes xanthomata etc. and the like, in particular of a human.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of an associated morbidity of the cardiovascular system, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of an associated morbidity of the abdomen, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of an associated morbidity of the brain and/or nerves, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia. In another embodiment of the present invention the composition I is for use in the treatment or prevention of transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke, in particular of a human subject having pre-hyper- cholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of an associated morbidity of the lungs, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of transient ischemic attack (which manifests as chest pain), pulmonary embolism, and/or respiratory failure, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of an associated morbidity of the eyes, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of an associated morbidity of the skin, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of xanthelasma palpebarum, in particular of a human subject having pre-hyper- cholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I is for use in the treatment or prevention of an associated morbidity of the tendons, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia. In another embodiment of the present invention the composition I is for use in the treatment or prevention of xanthomata, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition I for use in the treatment or prevention of (pre)hypercholesterolemia is an orally, enterally or parenterally, preferably orally administrable composition, in particular for a human subject.

In another embodiment of the present invention the composition I for use in the treatment or prevention of morbidities associated to (pre)hypercholesterolemia is an orally, enterally or parenterally, preferably orally administrable composition, in particular for a human subject.

In an embodiment of the present invention the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of a mammal, especially of pre-hypercholesterolemia of a human or especially of hypercholesterolemia of a human or especially of morbidities associated to (pre)hypercholesterolemia of a human.

In another embodiment of the present invention the composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto of a mammal, in particular of prehypercholesterolemia of a human or in particular of hypercholesterolemia of a human, or in particular of morbidities associated to (pre)hyper- cholesterolemia of a human.

In an embodiment of the present invention the composition I for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of a mammal, especially of pre-hypercholesterolemia of a human or especially of hypercholesterolemia of a human or especially of morbidities associated to (pre)hypercholesterolemia of a human, does not comprise one or more phytosterols.

In another embodiment of the present invention the composition I comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto of a mammal, in particular of pre-hypercholesterolemia of a human, or in particular of hypercholesterolemia of a human or in particular of morbidities associated to (pre)hyper- cholesterolemia of a human.

In another embodiment of the present invention the composition I comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto of a mammal, in particular of pre-hypercholesterolemia of a human, or in particular of hypercholesterolemia of a human or in particular of morbidities associated to (pre)hyper- cholesterolemia of a human.

It is understood that the embodiments mentioned for the composition I shall be applicable for the compositions I for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto and the specific embodiments thereto.

Furthermore, the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hyper- cholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol.

In an embodiment of the invention said method is for treating a subject having prehypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human. In an embodiment of the invention said method is for treating a subject having hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention said method is for treating a subject having morbidities associated to (pre)hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to (pre)hyper- cholesterolemia, in particular a human.

In another embodiment of the invention said human subject is in the age of 12 years or older, preferably 18 years or older, more preferably 35 years or older, in particular 50 years or older, even more particular 60 years or older.

It is understood that in this method the composition I can be administered, preferably orally, or that any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one phytosterol” and optional further components can be administered separately, preferably orally. Furthermore it is understood that in case composition I comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally, and in case composition I comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally, and in case composition I comprises as the at least one phytosterol two or more phytosterols these can be administered separately, preferably orally.

In an embodiment thereof, the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.

In another embodiment thereof, the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g.

In another embodiment thereof, the propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.

In a further embodiment thereof, the butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1 .0 to 5.0 g/day. In another embodiment the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g, preferably the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g, more preferably the daily application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 1 .5 to 4.0 g.

In another embodiment the daily application rate of the at least one phytosterol is from 0.5 to 10.0 g, preferably from 1 .0 to 5.0 g, in particular from 1 .5 to 3.0 g.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hyper- cholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hyper- cholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hyper- cholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of said composition I which does not comprise one or more phytosterols.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hyper- cholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

It is understood that the embodiments mentioned for the composition I shall be applicable for the use of the composition I in this method accordingly and in the specific embodiments thereto.

Furthermore, the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hyper- cholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hyper- cholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, which does not comprise one or more phytosterols, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hyper- cholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hyper- cholesterolemia and/or associated morbidities thereto.

In an embodiment of the invention the medicament manufactured as mentioned above is for treating a subject having pre-hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention the medicament manufactured as mentioned above is for treating a subject having hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human. In another embodiment of the invention the medicament manufactured as mentioned above is for treating a subject having morbidities associated to (pre)hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, in particular a human.

It is understood that the embodiments mentioned for the composition I shall be applicable for the use of the composition I in this use accordingly and in the specific embodiments thereto.

Furthermore, the present invention provides a nutritional supplement comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol.

For the purpose of the present invention the term “nutritional supplement” means a manufactured product intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of (pre)hypercholesterolemia and/or associated morbidities thereto. Examples for nutritional supplements include “dietary supplements” and “medical foods”. A dietary supplement is intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, however it needs not to be used under medical supervision. A medical food is also intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing (pre)hyper- cholesterolemia and/or associated morbidities thereto, but it is under medical supervision. The terms “medical foods” and “food for special medical purpose” are interchangeable.

It is understood that the nutritional supplement can comprise said composition I or that the nutritional supplement can comprise any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one phytosterol” and optional further components in separate form.

In an embodiment of the present invention the nutritional supplement is a dietary supplement.

In another embodiment of the present invention the nutritional supplement is a medical food.

In an embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto. In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment thereof, the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.

In another embodiment thereof, the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g.

Preferably, propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1.0 to 4.0 g/day.

Preferably butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.

In another embodiment the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g, preferably the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g, more preferably the daily application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 1 .5 to 4.0 g.

In another embodiment the daily application rate of the at least one phytosterol is from is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1.5 to 3.0 g.

In another embodiment of the invention said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years or older. It is understood that in this method the nutritional supplement can be administered, preferably orally, or that any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and the optional “at least one phytosterol” and optional further components can be administered separately, preferably orally. Furthermore it is understood that in case the nutritional supplement comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally, and in case the nutritional supplement comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally, and in case the nutritional supplement comprises as the at least one phytosterol two or more phytosterols these can be administered separately, preferably orally.

Furthermore, the present invention provides a nutritional supplement comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a nutritional supplement comprising a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia. In another embodiment the present invention provides a nutritional supplement comprising a composition I which does not comprise one or more phytosterols, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a nutritional supplement comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In another embodiment the present invention provides a nutritional supplement comprising a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol. In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition I as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the nutritional supplement accordingly and as well as to the specific embodiments thereto.

Furthermore, the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the nutritional supplement can comprise said composition I or that the nutritional supplement can comprise any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one phytosterol ” and optional further components in separate form. Furthermore, it is understood that in case composition I comprises as the at least one HMO two or more HMOs, these can be administered separately, preferably orally, and in case composition I comprises as at the least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof, these can be administered separately, preferably orally, and in case composition I comprises as the at least one phytosterol two or more phytosterols, these can be administered separately, preferably orally.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

In another embodiment the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment the present invention said method supplement is for the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, which does not comprise one or more phytosterols. In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition I as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the use of the nutritional supplement in this method accordingly as well as in the specific embodiments thereto.

Furthermore, the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, which does not comprise one or more phytosterols, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having pre-hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having or being suspected of having or being at risk of developing a morbidity associated to (pre)hypercholesterolemia, in particular a human.

It is understood that the embodiments mentioned for the composition I shall be applicable for the use of the composition I in this use accordingly and in the specific embodiments thereto.

Both, the medicament (in general and for the respective specific use) and the nutritional supplement (in general and for the respective specific use) of the present invention can be delivered in any suitable format. Formulations suitable for oral administration may be in the form of capsules, tablets, pills, dragees, lozenges (using a flavored basis, usually sucrose and acacia or tragacanth), powders, granules, and the like or as a solution or a suspension in an aqueous or non-aqueous liquid, or as an oil-in-water or water-in-oil liquid emulsion, or as an elixir or syrup, or as pastilles (using an inert base, such as gelatin and glycerin, or sucrose and acacia), each comprising a predetermined amount of the at least one HMO, the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, optional the at least one phytosterol and optional further components. The medicament (in general and for the respective specific use) and/or the nutritional supplement (in general and for the respective specific use) of the present invention may also be administered as a bolus, electuary or paste.

It is understood that the active ingredients of said medicament and nutritional supplement can be delivered together in a respective suitable format or that each of component A and component B and optionally component C can be delivered in a respective format or that each of the active ingredients can be delivered in a respective format, or any combination thereof.

In solid dosage forms for oral administration (capsules, tablets, pills, dragees, lozenges, powders, granules, and the like), the desired components of the composition I may be mixed with one or more pharmaceutically acceptable carriers, such as sodium citrate or dicalcium phosphate, and/or any of the following: (1) fillers or extenders, such as starches, lactose, sucrose, glucose, mannitol, and/or silicic acid; (2) binders, such as carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone, sucrose and/or acacia; (3) humectants, such as glycerol; (4) disintegrating agents, such as agar- agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate; (5) solution retarding agents, such as paraffin; (6) absorption accelerators, such as quaternary ammonium compounds; (7) wetting agents, such as acetyl alcohol and glycerol monostearate; (8) absorbents, such as kaolin and bentonite clay; (9) lubricants, such a talc, calcium stearate, magnesium stearate, solid polyethylene glycols, sodium lauryl sulfate, and mixtures thereof; (10) coloring agents; and (11) flavors, such as lemon, orange, apricot, banana, cherry, strawberry, raspberry, blueberry, peppermint, vanilla, chocolate, coffee, cappuccino flavor and the like. In some cases, the compositions I may also comprise buffering agents.

In a specific embodiment, powders and/or granules can be reconstituted with water or another aqueous liquid prior to consumption.

In a particular embodiment the so obtained liquid does not comprise more than 80 wt% water.

In another embodiment such above-mentioned liquid formulations do not comprise more than 80 wt% water.

Furthermore, the present invention provides a functional food comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol.

For the purpose of the present invention the term “functional food” means a food which is fortified with the composition I according to the present invention and intended to be used in a diet, in particular of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto. The terms “functional food” and “fortified food” are interchangeable.

Examples for foods being suitable for the preparation of functional foods are (1) dairy products e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) bakery products e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) candy products e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) beverage products e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.

It is understood that the functional food can comprise said composition I or that the functional food can comprise any of the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one phytosterol” and optional further components in separate form.

Furthermore it is understood that in case the composition I comprises as the at least one HMO two or more HMOs these can be comprised separately in the functional food or together as composition, and in case the composition I comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be comprised separately in the functional food or together as composition, and in case the composition I comprises as the at least one phytosterol compound two or more phytosterols these can be comprised separately in the functional food or together as composition.

In an embodiment of the present invention the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing pre hypercholesterolemia and/or associated morbidities thereto. In an embodiment of the present invention the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the present invention the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment thereof, the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.

In another embodiment thereof, the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g. Preferably, propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1.0 to 4.0 g/day. Preferably butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day. In another embodiment the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g, preferably the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g, more preferably the daily application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g.

In another embodiment of the invention said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years and older.

In another embodiment the daily application rate of the at least one phytosterol is is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1.5 to 3.0 g.

In an embodiment the present invention provides a functional food comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto. In another embodiment the present invention provides a functional food comprising a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a functional food comprising a composition I which does not comprise one or more phytosterols, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a functional food comprising a composition I which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol.

In another embodiment the present invention provides a functional food comprising a composition I which comprises i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment of the present invention said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia. In another embodiment of the present invention said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition I as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the functional food accordingly as well as to the specific embodiments thereto.

Furthermore, the present invention provides a method for the dietary management of a subject having, being suspected to have or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the “at least one HMO” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one phytosterol” and optional further components can be comprised separately in the functional food or together as composition. Furthermore it is understood that in case composition I comprises as the at least one HMO two or more HMOs these can be comprised separately in the functional food or together as composition, and in case composition I comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be comprised separately in the functional food or together as composition, and in case composition I comprises as at the least one phytosterol two or more phytosterols these can be comprised separately in the functional food or together as composition.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of a functional food which comprises a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

In another embodiment of the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, which does not comprise one or more phytosterols.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition I as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the use of the functional food in this method accordingly as well as in the specific embodiments thereto.

Furthermore, the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto. In an embodiment the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, which does not comprise one or more phytosterols, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and iii) at least one phytosterol, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition I, comprising i) as component A 2’-FL, and ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto. In an embodiment of the invention the functional food manufactured as mentioned above is for the dietary management of a subject having pre-hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention the functional food manufactured as mentioned above is for the dietary management of a subject having hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having morbidities associated to (pre)hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, in particular a human.

It is understood that the embodiments mentioned for the composition I shall be applicable for the use of the composition I in this use accordingly and in the specific embodiments thereto.

The functional food of the present invention can be prepared by known techniques and it can have any suitable type of format such as (1) a dairy product e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) a bakery product e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) a candy product e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) a beverage product e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.

Furthermore, it is contemplated herein that the composition I, the composition I for use as a medicament, the composition I for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, the nutritional supplement and the functional food, in particular for use in the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto, respectively, as disclosed herein, can be co-administered to subjects receiving at least one pharmaceutical against said (pre)hypercholesterolemia and/or associated morbidities thereto. Examples for pharmaceuticals used in the treatment of (pre)hypercholesterolemia are:

- lipid-lowering medications (statins, fibrates, nicotinic acid, cholestyramine and the like)

- immunomodulators (evolocumab, bococizumab, alirocumab and the like).

Furthermore, the present invention provides a method to treat a subject having (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject a) an effective amount of a composition I, a composition I for use as a medicament, a composition I for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, a nutritional supplement or a functional food, in particular for use in the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto, which comprises i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally iii) at least one phytosterol; and b) an effective amount of at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, in particular, wherein the application rate of the at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone.

In an embodiment thereof the (pre)hypercholesterolemia and/or associated morbidities thereto is (pre)hypercholesterolemia and the pharmaceutical is

- lipid-lowering medications (statins, fibrates, nicotinic acid, cholestyramine and the like)

- immunomodulators (evolocumab, bococizumab, alirocumab and the like)

Furthermore, the present invention provides a composition comprising a) i) at least one HMO, and/or ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and/or iii) at least one phytosterol; and b) an effective amount of at least one pharmaceutical, in particular for use as a medicament, especially for use in the treatment of (pre)hyper- cholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) i) as component A 2’-FL, and/or ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and/or iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol and b) lipid-lowering medications (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) as component A at least one HMO, preferably 2’-FL, and b) a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, without any C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and b) a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like)in a pharmaceutical effective amount, without any HMO, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and b) a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, without any C3-C4-alkane carboxylic acid or derivative(s) thereof and/or without HMO, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hyper- cholesterolemia and/or associated morbidities thereto.

It is understood that the embodiments mentioned for the components and for the diseases and the symptoms mentioned above shall apply here to.

In particular, the composition I, the composition I for use as a medicament, the composition I for use in the treatment or prevention of (pre)hypercholesterolemia, the nutritional supplement or the functional food, in particular for use in the dietary management of (pre)hypercholesterolemia, used in said method comprises

- 2’-FL, and/or

- propionic acid and/or butyric acid or derivative(s) thereof, and/or

- at least one of sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol, preferably 2’-FL, sodium propionate and sodium butyrate, and/or optionally sitosterol, in particular beta-sitosterol, and/or campesterol.

In another embodiment the composition I, the composition I for use as a medicament, the composition I for use in the treatment or prevention of a morbidity associated to (pre)hypercholesterolemia, the nutritional supplement or the functional food, in particular for use in the dietary management of a morbidity associated to (pre)hypercholesterolemia, used in said method comprises

- 2’-FL, and/or propionic acid and/or butyric acid or derivative(s) thereof, and/or at least one of sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol, preferably 2’-FL, sodium propionate and sodium butyrate, and/or optionally preferably sitosterol, in particular beta-sitosterol, and/or campesterol.

In an embodiment of the present invention the nutritional supplement or the functional food is for use in the dietary management of pre-hypercholesterolemia. In an embodiment of the present invention the nutritional supplement or the functional food is for use in the dietary management of hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of a morbidity associated to (pre)hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the cardiovascular system, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure, and/or deep vein thrombosis, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the abdomen, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of brain and/or nerves, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia. In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the lungs, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the eyes, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the skin, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia. In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of xanthelasma palpebarum, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the tendons, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of xanthomata, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

Furthermore, the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising at least one HMO and a second component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and optionally a third component comprising at least one phytosterol.

In an embodiment the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, and a second component comprising propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and optionally a third component comprising sitosterol, in particular beta- sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, a second component comprising propionic acid or derivative(s) thereof, preferably sodium propionate, and a third component comprising butyric acid or derivative(s) thereof, preferably sodium butyrate, and optionally a forth component comprising sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta- sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment the present invention provides said kit for the pharmaceutical use for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto or dietary management use for the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides said kit for the pharmaceutical use or dietary management use for the treatment or prevention of pre-hypercholesterolemia or dietary management use for the dietary management of pre-hypercholesterolemia.

In another embodiment the present invention provides said kit for the pharmaceutical use or dietary management use for the treatment or prevention of hypercholesterolemia or dietary management use for the dietary management of hypercholesterolemia.

In another embodiment the present invention provides said kit for the pharmaceutical use or dietary management use for the treatment or prevention of morbidities associated to (pre)hypercholesterolemia or dietary management use for the dietary management of associated morbidities to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the components A and B and C shall be applicable for the kit accordingly and in the specific embodiments thereto.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one HMO, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and optionally a third component comprising at least one C3- C4-alkane carboxylic acid or derivative(s) thereof.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is 2’-FL, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, and optionally a third component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate. Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and optionally a third component comprising at least one HMO.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is propionic acid and/or butyric acid or derivative(s) thereof, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, and optionally a third component which is 2’-FL.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one phytosterol and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and optionally a third component comprising at least one HMO and/or at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta- sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, and optionally a third component 2’-FL, and/or optionally a third component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one HMO and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and a third component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and a forth component comprising at least one phytosterol. In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is 2’-FL, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, a third component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and a forth component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta- sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

It is understood that the embodiments mentioned for the components A, B and C as well as for the diseases shall be applicable for the kit accordingly and in the specific embodiments thereto.

Within the context of the present invention, the term "butyric acid" denotes n-butyric acid and the term “butyrate” denotes n-butyrate. Also within the content of the present invention, the term ”at least one HMO” is interchangeable with the term ’’component A”, and the term ”at least one C3-C4-alkane carboxylic acid or a derivative thereof’ is interchangeable with the term “component B”, and the term “at least one phytosterol” is interchangeable with the term “component C”.

Wthin the context of the present application, it is noted that in case a composition comprises several components that these can also be administered separately. However, this means that such components can be administered together or separately, as the case may be.

Also, within the context of the present invention, ratios given are weight to weight ratios unless stated otherwise. The weight unit “meg” stands for micro gram. In addition, in the context of the invention, the terms "comprising" or "comprises" do not exclude other possible elements. The composition of the present invention, including the embodiments described herein, can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise depending on the needs. The terminology as set forth herein is for description of the embodiments only and should not be construed as limiting the disclosure as a whole. In a particular embodiment the compositions of the invention consist essentially of the essential elements, and even more particular consist of the essential elements. Furthermore, as used in the description and the appended claims, the singular forms "a", "an", and "the" are inclusive of their plural forms, and the other way around, unless the context clearly indicates otherwise. It is to be understood that the embodiments of the subject matter of the invention can be applied in the specific context but also in other combinations, without leaving the scope of the invention. E.g. it is understood that the embodiments mentioned for the composition of the present invention also apply for composition for use as a medicament, etc. The same applies for the respective conditions and/or diseases.

In the following specific embodiments I of the present invention are described.

1-1. A composition I comprising i) at least one HMO, and ii) at least one C3-C4-alkane carboxylic acid or a derivative thereof, and optionally iii) at least one phytosterol.

2-1. The composition I according to embodiment 1-1, wherein one of the at least one HMO’s is a fucosylated oligosaccharide.

3-1. The composition I according to embodiment 1-1 or 2-1, wherein one of the at least one HMO is

2’-fucosyllactose (2’-FL).

4-1. The composition I according to any one of embodiments 1-1 to 3-1, wherein one of the at least one HMO’s is a sialylated oligosaccharide.

5-1. The composition I according to any one of embodiments embodiment 1-1 to 4-1, wherein one of the at least one HMO is 6’-sialyllactose (6’-SL).

6-1. The composition I according to any one of embodiments 1-1 to 5-1, wherein one of the at least one HMO’s is a N-acetylated oligosaccharide.

7-1. The composition I according to any one of embodiments 1-1 to 6-1, wherein one of the at least one HMO is lacto-N-tetraose (LNT).

8-1. The composition I according to any one of embodiments 1-1 to 7-1, wherein the at least one

HMO is one or more HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyllactose (in particular 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL.

9-1. The composition I according to any one of embodiments 1-1 to 8-1, wherein the at least one

HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyllactose (in particular 2’, 2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL. 10-1. The composition I according to any one of embodiments 1-1 to 9-1, wherein the at least one

HMO is one, two or three HMOs selected from the group consisting of 2’-FL, LNT, LNnT, 3’-SL and 6’-SL.

11-1. The composition I according to any one of embodiments 1-1 to 9-1, wherein the at least one

HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 2’,2”-DiFL and 3,2’-DiFL.

12-1. The composition I according to any one of embodiments 1-1 to 11-1 wherein the at least one

HMO is 2’-FL.

13-1. The composition I according to any one of embodiments 1-1 to 12-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof.

14-1. The composition I according to any one of embodiments 1-1 to 13-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of propionic acid.

15-1. The composition I according to any one of embodiments 1-1 to 14-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of propionic acid.

16-1. The composition I according to any one of embodiments 1-1 to 15-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium salt of propionic acid.

17-1. The composition I according to any one of embodiments 1-1 to 16-1 wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate.

18-1. The composition I according to any one of embodiments 1-1 to 14-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid.

19-1. The composition I according to any one of embodiments 1-1 to 18-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is butyric acid or a derivative thereof. 20-I. The composition I according to any one of embodiments 1-1 to 19-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of butyric acid.

21-1. The composition I according to any one of embodiments 1-1 to 20-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of butyric acid.

22-1. The composition I according to any one of embodiments 1-1 to 21-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium salt of butyric acid.

23-1. The composition I according to any one of embodiments 1-1 to 22-1 wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium butyrate.

24-1. The composition I according to any one of embodiments 1-1 to 20-1, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of butyric acid.

25-I. The composition I according to any one of embodiments 1-1 to 24-1, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof and butyric acid or a derivative thereof.

26-1. The composition I according to any one of embodiments 1-1 to 25-1, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt of propionic acid and physiologically acceptable salt of butyric acid.

27-1. The composition I according to any one of embodiments 1-1 to 26-1, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of propionic acid and an alkali salt or an alkaline earth salt of butyric acid.

28-1. The composition I according to any one of embodiments 1-1 to 27-1, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium salt of propionic acid and a sodium or potassium salt of butyric acid.

29-1. The composition I according to any one of embodiments 1-1 to 28-1 wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate and sodium or potassium butyrate. 30-I. The composition I according to any one of embodiments 1-1 to 25-1, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable ester of propionic acid and a physiologically acceptable ester of butyric acid.

31-1. The composition I according to any one of embodiments 1-1 to 30-1, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid and a C1 -C6 alkyl ester or a mono- or diglyceride of butyric acid.

32-I. The composition I according to any one of embodiments 1-1 to 31-1 which does not comprise one or more phytosterols.

33-1. The composition I according to any one of embodiments 1-1 to 31-1 which comprises at least one phytosterol.

34-1. The composition I according to any one of embodiments 1-1 to 33-1, wherein the at least one phytosterol is at least one of plant sterols or plant stanols, wherein said plant sterols and/or said plant stanols are present in free form and/or in ester form.

35-1. The composition I according to embodiment 1-1 to 34-1, wherein the plant sterol and the plant stanol is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5- avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol.

36-1. The composition I according to any one of embodiments 1-1 to 35-1, wherein the plant sterol and the plant stanol is a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol.

37-1. The composition I according to any one of embodiments 1-1 to 36-1, wherein the plant sterol and the plant stanol is a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

38-1. The composition I according to any one of embodiments 1-1 to 37-1, wherein the weight to weight ratio of the at least one HMO (component A) : the at least one C3-C4 alkane carboxylic acid or a derivative thereof (component B) is from 100:1 to 1 :100. 39-I. The composition I according to any one of embodiments 1-1 to 38-1, wherein the weight to weight ratio of (component A) : (component B) is from 20:1 to 1 :20, preferably from 10:1 to 1 :10, more preferably from 3:1 to 1 :3, in particular from 2:1 to 1 :2.

40-I. The composition I according to any one of embodiments 25-I to 39-I, wherein the weight to weight ratio of the propionic acid or a derivative thereof : butyric acid or a derivative thereof is from 100:1 to 1 : 100.

41-1. The composition I according to any one of embodiments 25-1 to 40-1, wherein the weight to weight ratio of the propionic acid or a derivative thereof : butyric acid or a derivative thereof is from 20:1 to 1 :20, preferably from 10:1 to 1 :15, more preferably from 2:1 to 1 :8.

42-I. The composition I according to any one of embodiments 1-1 to 41-1, wherein the weight to weight ratio of (component A) : (component C) is from 50:1 to 1 :100, preferably from 25:1 to 1 :50, more preferably from 20.1 to 1 :30.

43-I. The composition I according to any one of embodiments 1-1 to 42-1, wherein the weight to weight ratio of (component B) : (component C) is from 10:1 to 1 : 100, preferably from 5:1 to 1 :50, more preferably from 2:1 to 1 :10.

44-I. The composition I according to any one of embodiments 1-1 to 43-1, wherein the at least one

HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.

45-1. The composition I according to any one of embodiments 1-1 to 44-1, wherein the at least one

HMO and the at least one phytosterol are present in synergistic amounts.

46-1. The composition I according to any one of embodiments 1-1 to 45-1, wherein the at least one

C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol are present in synergistic amounts.

47-1. The composition I according to any one of embodiments 1-1 to 46-1, wherein the at least one

HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol are present in synergistic amounts.

48-1. The composition I according to any one of embodiments 1-1 to 47-1, wherein the total amount of the at least one HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and optionally the at least one phytosterol is from 1 to 100 wt% of the total composition I, preferably from 10 to 100 wt%.

49-I. The composition I according to any one of embodiments 1-1 to 48-1, wherein the total amount of the at least one HMO is from 0.5 to 95 wt% of the total composition I, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%.

50-I. The composition I according to any one of embodiments 1-1 to 48-1, wherein the total amount of the at least one HMO is from 0.5 to 50 wt% of the total composition I, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%.

51-1. The composition I according to any one of embodiments 1-1 to 49-1, wherein the total amount of the at least one HMO is from 50 to 95 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

52-1. The composition I according to any one of embodiments 1-1 to 51-1, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 95 wt% of the total composition I, preferably from 10 to 90 wt%, more preferably from 15 to 85 wt%, even more preferably from 20 to 75 wt%, in particular from 25 to 60 wt%

53-I. The composition I according to any one of embodiments 1-1 to 52-1, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 50 wt% of the total composition I, preferably from 10 to 45 wt%, more preferably from 15 to 35 wt%.

54-I. The composition I according to any one of embodiments 1-1 to 52-1, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 90 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

55-1. The composition I according to any one of embodiments 1-1 to 54-1, wherein the total amount of the at least one phytosterol is from 1.0 to 95 wt% of the total composition I, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%, or wherein the total amount of the at least one phytosterol is from 0.5 to 50 wt% of the total composition I, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%, or wherein the total amount of the at least one phytosterol is from 50 to 95 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%. 56-I. The composition I according to any one of embodiments 1-1 to 55-1, wherein the composition I further comprises one or more vitamins or related compounds thereto.

57-1. The composition I according to embodiment 56-1, wherein the one or more vitamins or related compounds thereto are selected from the group of vitamin A, vitamin B1 , vitamin B2, vitamin B3, pantothenic acid, vitamin B6, biotin, folic acid, vitamin B12, vitamin E, vitamin K, vitamin C and vitamin D, or related compounds thereto and/or mixtures thereof.

58-I. The composition I according to embodiment 57-I, wherein the composition I further comprises one or more carotenoids.

59-I. The composition I according to embodiment 58-I, wherein the one or more carotenoids are selected from the group of astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lutein, lycopene, meso-zeaxanthin, zeaxanthin and the like (including cis/trans isomers) and/or mixtures thereof.

60-I. The composition I according to any one of embodiments 1-1 to 59-1, wherein the composition I further comprises one or more medium-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof.

61-1. The composition I according to embodiment 60-1, wherein the one or more medium chain fatty acids are selected from the group of caproic acid, caprylic acid, capric acid, lauric acid and/or mixtures.

62-1. The composition I according to any one of embodiments 1-1 to 61-1, wherein the composition I further comprises one or more long-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof.

63-1. The composition I according to embodiment 62-1, wherein the one or more long chain fatty acids are selected from the group of saturated long chain fatty acids, mono-unsaturated long chain fatty acids, polyunsaturated long chain fatty acids and/or mixtures thereof.

64-1. The composition I according to any one of embodiments 1-1 to 63-1, wherein the composition I further comprises one or more prebiotics.

65-1. The composition I according to embodiment 64-1, wherein the one or more prebiotics are selected from the group of water-insoluble fibers, water-soluble fibers, or oligosaccharides, preferably xylooligosaccharides, fructooligosaccharides, galactooligosaccharides and/or isomalto-oligosaccharides, and/or mixtures thereof.

66-I. The composition I according to any one of embodiments 1-1 to 65-1, wherein the composition I further comprises one or more probiotics.

67-1. The composition I according to embodiment 66-1, wherein the one or more probiotics are selected from the group of the family Lactobacilaceae, preferably of the genus Lactobacillus, in particular of the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii, lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus rhamnosus, lactobacillus salivarius, of the genus Bifidobacterium, in particular of the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum, of the genus Pediococcus, in particualar of the species pediococcus acidilactici, pediococcus pentosaceus, of the genus Lactococcus, in particular of the species lactococcus lactis, of the genus Streptococcus, in particular of the species streptococcus thermophilus, of the genus Faecalibacterium, in particular of the species faecalibacterium prausnitzii, of the genus Bacillus, in particular of the species bacillus subtilis, and/or mixtures thereof.

68-1. The composition I according to any one of embodiments 1-1 to 67-1, wherein the composition I further comprises one or more phenolic compounds.

69-1. The composition I according to embodiment 68-1, wherein the one or more phenolic compounds are selected from the group of monophenols, flavonoids, isoflavonoids, aurones, chalconoids, flavonolignans, lignans, phytoestrogens, stilbenoids, piceatannol, curcuminoids, tannins, aromatic acids, phenylethanoids, capsaicin, gingerol, alkylresorcinol and/or mixtures thereof.

70-1. The composition I according to any one of embodiments 1-1 to 69-1, wherein the composition I further comprises one or more herbals.

71-1. The composition I according to embodiment 70-1, wherein the one or more herbals are selected from herbals known from Chinese diets, Indian diets, Mediterranean diets and/or mixtures thereof.

72-1. The composition I according to any one of embodiments 1-1 to 71-1, wherein the composition I further comprises one or more minerals. 73-I. The composition I according to any one of embodiments 1-1 to 72-1, wherein the composition does not comprise an antibody.

74-1. A composition I as described in any one of the embodiments 1-1 to 73-1 for use as a medicament, preferably as a medicament for mammals and/or birds, more preferably for mammals, even more preferably for humans.

75-1. A composition I as described in any one of embodiments 1-1 to 73-1 for use in the treatment and/or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans.

76-1. The composition I according to embodiment 75-1, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is a pre-hypercholesterolemia, in particular of a human.

77-1. The composition I according to embodiment 76-1, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is a hypercholesterolemiai, in particular of a human.

78-1. The composition I according to embodiment 75-1, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is an associated morbidity, in particular of a human.

79-1. The composition I as described in any one of embodiments 1-1 to 78-1, wherein the associated morbidity is an associated morbidity of the cardiovascular system, an associated morbidity of the abdomen, an associated morbidity of the brain and/or nerves, an associated morbidity of the lungs, an associated morbidity of the eyes, an associated morbidity of the skin, or an associated morbidity of the tendons, in particular a human, even more particular a human having (pre)hypercholesterolemia.

80-1. The composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis, in particular a human, even more particular a human having (pre)hypercholesterolemia.

81-1. The composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -I. The composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -1. The composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -1. The composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is transient arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -1. The composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is xanthelasma palpebarum of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -1. The composition I as described in any one of embodiments 1-1 to 79-1, wherein the associated morbidity is xanthomata of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -1. The composition I according to any one of embodiments 74-1 to 86-1, wherein the composition

I is an orally administrable composition. -1. A method for treating a subject having, suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto comprising administering to the subject an effective amount of a composition I according to any one of embodiments 1-1 to 73-1. -1. The method according to embodiment 88-1, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing (pre)hypercholesterolemia. 90-I. The method according to embodiment 88-I, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

91-1. The method according to any one of embodiments 88-1 to 90-1, wherein the application rate of the at least one HMO is from 0.1 to 20.0 g/day, preferably from preferably from 1.0 to 15.0 g/day, more 2.0 to 10.0 g/day, in particular from 2.5 to 5.0 g/day.

92-I. The method according to any one of embodiments 88-I to 91-1, wherein the application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g/day, preferably from 1.0 to 9.0 g/day, more preferably from 1 .2 to 9.0 g/day, in particular from 2.0 to 8.0 g/day, especially from 2.5 to 6.0 g/day.

93-I. The method according to any one of embodiments 88-I to 92-I, wherein one of the at least one

C3-C4-alkane carboxylic acid or derivative(s) thereof is propionic acid or a derivative thereof and is applied at a rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1.0 to 4.0 g/day.

94-I. The method according to any one of embodiments 88-I to 93-I, wherein one of the at least one

C3-C4-alkane carboxylic acid or derivative(s) thereof is butyric acid and/or a derivative thereof and is applied at a rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.

95-I. The method according to any one of embodiments 88-I to 94-I, wherein the at least one C3-

C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day.

96-I. The method according to any one of embodiments 88-I to 95-I, wherein the application rate of at least one phytosterol is from 0.5 to 10.0 g, preferably from 1 .0 to 5.0 g, in particular from 1.5 to 3.0 g per day. -I. The method according to any one of embodiments 88-I to 96-I, wherein the composition I is administered orally. -I. A nutritional supplement or a functional food comprising a composition I according to any one of embodiments 1-1 to 73-1. -1. The nutritional supplement or the functional food according to embodiment 98-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans. 0-1. The nutritional supplement or functional food according to embodiment 99-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia, in particular pre-hypercholesterolemia or in particular hypercholesterolemia, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans. 1-1. The nutritional supplement or functional food according to embodiment 99-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans. 2-1. The nutritional supplement or functional food according to embodiment 101-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing an associated morbidity of the cardiovascular system, an associated morbidity of the abdomen, an associated morbidity of the brain and/or nerves, an associated morbidity of the lungs, an associated morbidity of the eyes, an associated morbidity of the skin, or an associated morbidity of the tendons, in particular of a human, even more particular of a human having (pre)hypercholesterolemia. 3-1. The nutritional supplement or functional food according to embodiment 102-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis, in particular of a human, even more particular of a human having (pre)hypercholesterolemia. 104-1. The nutritional supplement or functional food according to embodiment 102-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

105-1. The nutritional supplement or functional food according to embodiment 102-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

106-1. The nutritional supplement or functional food according to embodiment 102-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

107-1. The nutritional supplement or functional food according to embodiment 102-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

108-1. The nutritional supplement or functional food according to embodiment 102-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing xanthelasma palpebarum, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

109-1. The nutritional supplement or functional food according to embodiment 102-1 for use in the dietary management of subjects having, being suspected of having or being at risk of developing xanthomata, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

110-1. A method for the dietary management of a subject having, suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, comprising administering to the subject an effective amount of a composition I according to any one of embodiments 1 -I to 73-I or a nutritional supplement according to any one of embodiments 98-I to 109-1 or a functional food according to any one of embodiments 98-1 to 109-1.

111-1. The method according to claim 110-1, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing (pre)hypercholesterolemia.

112-1. The method according to claim 110-1, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

113-1. The method according to any one of embodiments 110-1 to 112-1, wherein the application rate of the at least one HMO is from 0.1 to 20.0 g/day, preferably from 1.0 to 15.0 g/day, more preferably from 2.0 to 10.0 g/day, in particular from 2.5 to 5.0 g/day.

114-1. The method according to any one of embodiments 104-1 to 113-1, wherein the application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g/day, preferably from f1.0 to 9.0 g/day, more preferably from 1.2 to 9.0 g/day, in particular from 2.0 to 8.0 g/day, especially from 2.5 to 6.0 g/day.

115-1. The method according to any one of embodiments 104-1 to 114-1, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is propionic acid or a derivative thereof and is applied at a rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1.0 to 4.0 g/day.

116-1. The method according to any one of embodiments 104-1 to 115-1, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is butyric acid and/or a derivative thereof and is applied at a rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.

117-1. The method according to any one of embodiments 104-1 to 116-1, wherein the at least one C3-

C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day. -1. The method according to any one of embodiments 104-1 to 117-1, wherein the application rate of the at least one phytosterol is from 0.5 to 10.0 g, preferably from 1 .0 to 5.0 g, in particular from 1.5 to 3.0 g per day. -1. The method according to any one of embodiments 104-1 to 118-1, wherein the nutritional supplement or the functional food is administered orally. -1. A composition I according to any one of embodiments 1-1 to 73-1, a composition I for use as a medicament according to embodiment 74-1, a composition I for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-1 to 87-1, a nutritional supplement or a functional food according to any one of embodiments 98-1 to 109-1, which is administered to a subject having or being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, wherein the composition I according to any one of embodiments 1-1 to 73-1, the composition I for use as a medicament according to embodiment 74-1, the composition I for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-1 to 87-1, the nutritional supplement or a functional food according to any one of embodiments 98-1 to 109-1 is administered to the subject in addition to at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, in particular wherein the application rate of the pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, is reduced compared to a treatment with said pharmaceutical alone. -1. A composition I for use in the treatment or prevention of (pre)hypercholesterolemia according to any one of embodiments 73-1 to 87-1, a nutritional supplement or a functional food according to any one of embodiments 98-1 to 109-I, which is administered to a subject having or being suspected of having or being at risk of developing (pre)hypercholesterolemia, wherein the composition I for use in the treatment or prevention of (pre)hypercholesterolemia according to any one of embodiments 75-I to 87-I, the nutritional supplement or a functional food according to any one of embodiments 98-I to 109-1 is administered to the subject in addition to at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia, in particular wherein the application rate of the pharmaceutical suitable to treat said (pre)hypercholesterolemia, is reduced compared to a treatment with said pharmaceutical alone. -1. A composition I for use in the treatment or prevention of morbidities associated to

(pre)hypercholesterolemia according to any one of embodiments 75-1 to 87-1, a nutritional supplement or a functional food according to any one of embodiments 98-1 to 109-I, which is administered to a subject having or being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, wherein the composition I for use in the treatment or prevention of morbidities associated to (pre)hypercholesterolemia according to any one of embodiments 75-I to 87-I, the nutritional supplement or a functional food according to any one of embodiments 98-I to 109-I is administered to the subject in addition to at least one pharmaceutical suitable to treat said morbidities associated to (pre)hypercholesterolemia, in particular wherein the application rate of the pharmaceutical suitable to treat said morbidities associated to (pre)hypercholesterolemia, is reduced compared to a treatment with said pharmaceutical alone. -1. A method to treat a subject having (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject a) an effective amount of a composition I according to any one of embodiments 1-1 to 73-1, a composition I for use as a medicament according to embodiment 74-1, a composition I for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-1 to 87-1, a nutritional supplement or a functional food according to any one of embodiments 98-1 to 109-1, or with one, two or three of components A, B and C as described in any one of embodiments 1-1 to 73-1, and b) an effective amount of at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, wherein the application rate of the at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone. -1. The method according to embodiment 123-1, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is (pre)hypercholesterolemia and wherein the at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia, is selected from the group of pharmaceuticals of lipid lowering medications (preferably statins, fibrates, nicotinic acid and/or cholestyramine) or immunmodulators (preferably evolocumab, bococizumab and/or alirocumab). 125-1. A composition comprising a) i) at least one HMO, and/or ii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and/or iii) at least one phytosterol; and b) an effective amount of at least one pharmaceutical, especially being suitable for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, in particular for use as a medicament, especially for use in the treatment or prevention of hypercholesterolemia and/or associated morbidities thereto.

126-1. A composition comprising a) i) as component A 2’-FL, and/or ii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and/or iii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta- sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol; and b) a lipid lowering medications (preferably a statin, fibrate, nicotinic acid and/or cholestyramine) or a immunmodulator (preferably evolocumab, bococizumab and/or alirocumab) in a pharmaceutical effective amount, in particular for use as a medicament, especially for use in the treatment or prevention for hypercholesterolemia and/or associated morbidities thereto.

127-1. Use of the composition I as defined in any one of embodiments 1-1 to 73-1 as a nutritional supplement or as a functional food for the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto.

128-1. A composition I for use as a medicament according to embodiment 74-1, a composition I for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-1 to 87-1, a nutritional supplement or a functional food according to any one of embodiments 98-1 to 109-1, a composition according to any one of embodiments 120-1 to 126-1, wherein the subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years or older.

129-1. A method according to any one of embodiments 88-1 to 97-1 or 110-1 to 119-1 or 123-1 to 124-

I, wherein the subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older even more in particular 60 years or older.

130-1. A kit for the pharmaceutical use or dietary management use comprising a first component A being at least one HMO, preferably as described in any one of embodiments 1-1 to 73-1, and a second component B being at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, preferably as described in any of embodiments 1-1 to 72-1, and optionally a third component C being at least one phytosterol, preferably as described in any embodiments 1-1 to 73-1 for the treatment or prevention or dietary management use of (pre)hypercholesterolemia and/or associated morbidities thereto.

131-1. The kit according to embodiment 130-1, wherein the kit is for the pharmaceutical use for the treatment or prevention of (pre)hypercholesterolemia or dietary management use of (pre)hypercholesterolemia.

132-1. The kit according to embodiment 130-1, wherein the kit is for the pharmaceutical use for the treatment or prevention of morbidities associated to (pre)hypercholesterolemia or dietary management use of morbidities associated to (pre)hypercholesterolemia.

It has now been found that HMOs can be combined with at least one phytosterol, and optionally with C3-C4-alkane carboxylic acids or derivatives thereof. Such compositions provide beneficial effects as described herein.

The present invention provides composition II. The composition II comprises i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

For the purpose of the present invention, the term “HMO" refers to human milk oligosaccharide(s). These carbohydrates are resistant to enzymatic hydrolysis by digestive enzymes (e.g. pancreatic and/or brush border). In the human breast milk many different kinds of HMOs are found. Each individual HMO is based on a combination of glucose, galactose, sialic acid (N-acetylneuraminic acid), fucose and/or N-acetylglucosamine with many and varied linkages between them. So far over 130 such structures have been identified in human milk. Almost all of them have a lactose moiety at their reducing end while sialic acid and/or fucose (when present) occupy terminal positions at the non-reducing ends. The HMOs can be acidic (e.g. charged sialic acid containing oligosaccharide) or neutral (e.g. fucosylated oligosaccharide).

In an embodiment of the present invention the HMO is selected from the group of fucosylated oligosaccharides, N-acetylated oligosaccharides and sialylated oligosaccharides.

In an embodiment of the present invention the HMO is a "fucosylated oligosaccharide". These are HMOs having a fucose residue. It has a neutral nature. Some examples are 2'-FL (2'-fucosyllactose), 3-FL (3-fucosyllactose), difucosyllactose, lacto-N-fucopentaose (e.g. lacto-N- fucopentaose I, lacto- N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V), lacto-N-fucohexaose, lacto-N- difucohexaose I, fucosyllacto-N-hexaose, fucosyllacto- N-neohexaose, difucosyllacto-N-hexaose I, difucosyllacto-N-neohexaose II and any combination thereof. In a preferred embodiment the fucosylated oligosaccharide is selected from the group comprising 2’-FL, 3-FL and difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL). In particular the fucosylated oligosaccharide is 2’-FL.

In another embodiment of the present invention the HMO is a ”N-acetylated oligosaccharide”. The term ”N-acetylated oligosaccharide(s)” encompasses both "N-acetyl-lactosamine" and "oligosaccharide(s) containing N-acetyl-lactosamine". They are neutral oligosaccharides having an N-acetyl-lactosamine residue. Suitable examples are LNT (lacto-N-tetraose), para-lacto-N- neohexaose (para-LNnH), LNnT (lacto-N-neotetraose) or any combination thereof. Other examples are lacto-N-hexaose, lacto-N-neohexaose, para-lacto-N-hexaose, para-lacto-N-neohexaose, lacto- N-octaose, lacto-N- neooctaose, iso- lacto-N-octaose, para- lacto-N-octaose and lacto-N-decaose or any combination thereof. In a preferred embodiment the N-acetylated oligosaccharide is selected from the group of LNT and LNnT.

In another embodiment of the present invention the HMO is a ’’sialylated oligosaccharide". The term ’’sialylated oligosaccharide” encompasses an oligosaccharide having a sialic acid residue. It has an acidic nature. Some examples are 3’-SL (3'-sialyllactose) and 6’-SL (6'-sialyllactose). In a preferred embodiment the sialylated oligosaccharide is 6’-SL.

In another embodiment the HMO is selected from the group comprising 2’-FL, 3-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL and/or any combination thereof. In particular, the HMO is selected from the group comprising 2’-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3,2’-DiFL), LNT, LNnT and 6’-SL and/or any combination thereof. Especially the HMO is selected from the group comprising 2’-FL, LNT, LNnT and 6'-SL and/or any combination thereof.

For the purpose of the present invention, the term “C3-C4-alkane carboxylic acid or derivative thereof’ encompasses propionic acid, n-butyric acid and iso-butyric acid (2-methyl propionic acid) as well as derivatives thereof and/or any mixture thereof. Suitable derivatives are salts, esters and amides, in particular physiologically acceptable ones.

Examples for physiologically acceptable salts are alkali salts, like sodium or potassium salts, or alkaline-earth salts, like magnesium or calcium salts, or choline salts. Preferably the physiologically acceptable salts are alkali salts, in particular sodium salts or potassium salts, especially sodium salts.

Examples for physiologically acceptable esters are those derived from C1-C6 alcohols, in particular those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or dihydric C1-C6 alcohols, like those derived from 1 ,2-ethandiol, or C1-C4 alkoxy substituted monohydric alcohols, like those derived from 2-methoxyethanol, 2-ethoxyethanol or 2-butoxyethanol. Other examples for physiologically acceptable esters are glycerides, like mono-, di-, or triglycerides, in particular mono- or diglycerides. Preferably the physiologically acceptable esters are those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or mono- or diglycerides.

Examples for physiologically acceptable amides are those derived from mono- or di-C1-C6-alkyl amines.

In an embodiment of the present invention the C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid (= free propionic acid) or butyric acid (= free butyric acid) or a mixture thereof.

In another embodiment the C3-C4 alkane carboxylic acid is provided as physiologically acceptable derivative thereof; in particular the derivative is a physiologically acceptable salt, e.g. a sodium salt or potassium salt, or a mixture thereof, or a physiologically acceptable ester, e.g. said ester is derived from C1-C6 alcohols, in particular a mono-or a dihydric C1-C6 alcohol, or said ester is a mono- or diglyceride, or a mixture thereof.

In a further embodiment the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate or sodium butyrate or potassium butyrate or a mixture thereof. Especially, it is sodium propionate or sodium butyrate or a mixture thereof. In a further embodiment the C3-C4-alkane carboxylic acid or derivative thereof is propionic acid or a derivative thereof, in particular it is a physiologically acceptable salt of propionic acid, especially it is sodium propionate or potassium propionate, or a physiologically acceptable ester of propionic acid, especially methyl propionate or ethyl propionate or propionic acid monoglyceride or propionic acid diglyceride, particularly ethyl propionate or propionic acid monoglyceride. In a particular embodiment the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate.

In a further embodiment the C3-C4-alkane carboxylic acid or derivative thereof is butyric acid or a derivative thereof, in particular it is a physiologically acceptable salt of butyric acid, especially it is sodium butyrate or potassium butyrate, or a physiologically acceptable ester of butyric acid, especially methyl butyrate or ethyl butyrate or butyric acid monoglyceride or butyric acid diglyceride, particularly ethyl butyrate or butyric acid monoglyceride. In a particular embodiment the C3-C4- alkane carboxylic acid or derivative thereof is sodium butyrate or potassium butyrate.

In a further embodiment the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of propionic acid and butyric acid or derivatives thereof, in particular it is a mixture of physiologically acceptable salts of propionic acid and butyric acid, especially it is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate, or a mixture of physiologically acceptable esters of propionic acid and butyric acid, especially a mixture of methyl propionate and methyl butyrate, or a mixture of ethyl propionate and ethyl butyrate, or a mixture of propionic acid monoglyceride and butyric acid monoglyceride, or a mixture of propionic acid diglyceride and butyric acid diglyceride, particularly a mixture of ethyl propionate and ethyl butyrate or a mixture of propionic acid monoglyceride and butyric acid monoglyceride. In a particular embodiment the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate.

For the purpose of this invention, the term “phytosterol” relates to at least one plant sterol or plant stand, being present in the free form and/or in the ester form. Examples for plant sterols are sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7- stigmasterol, and the like, and examples for plant stands are sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol, D7-stigmastanol, and the like. In one embodiment they can be present in the form of esters, in particular they are fatty acid esters. Said fatty acids are usually obtained from vegetable oils, like soy bean oil, rape oil and the like. In another embodiment the plant sterol or plant stand can be present in free form. Also, mixtures of the free form and the ester form are possible. Unless otherwise specified in the present application, the terms “phytosterol”, “plant sterol”, “plant stanol” as well the individual examples mentioned above relate to the respective free form, or the ester form or mixtures thereof.

In a preferred embodiment the at least one phytosterol is a mixture of two or more phytosterols, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or in another embodiment preferably a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or in another embodiment preferably a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment the at least one phytosterol is derived from vegetable sources, in particular it comprises 40 to 60 weight percent equivalent sitosterol, especially beta-sitosterol, and 10 to 40 weight percent equivalent campesterol. Within this application weight percentage equivalent refer to the weight contribution of the sterol/stanol backbone only, that means that in case the phytosterol is present in ester form the weight contribution of the ester moiety is not counted. The contribution of all sterol/stanol backbones present sums up to 100% weight percent equivalents. In another embodiment the at least one phytosterol derived from vegetable sources comprises 40 to 60 weight percent equivalent sitosterol, especially beta-sitosterol, 10 to 40 weight percent equivalent campesterol and 10 to 30 weight percent equivalent stigmasterol, or it comprises 40 to 60 weight percent equivalent sitosterol, especially beta-sitosterol, 10 to 40 weight percent equivalent campesterol and 0.1 to 3.0 weight percent equivalent stigmasterol.

In another embodiment the at least one phytosterol is derived from wood sources, e.g. from pine, in particular it comprises 45 to 80, especially 65 to 80, weight percent equivalent sitosterol, especially beta-sitosterol, and 3 to 25 weight percent equivalent campesterol. In another embodiment the at least one phytosterol derived from wood sources comprises 45 to 80, especially 65 to 80, weight percent equivalent sitosterol, especially beta-sitosterol, 3 to 25 weight percent equivalent campesterol and 0 to 2 weight percent equivalent stigmasterol, or it comprises 45 to 80, especially 65 to 80, weight percent equivalent sitosterol, especially beta-sitosterol, 3 to 25 weight percent equivalent campesterol and 10 to 20 weight percent equivalent sitostanol, especially beta-sitostanol.

In an embodiment of the present invention the composition II comprises i) at least one HMO, and ii) at least one phytosterol.

In another embodiment of the present invention the composition II comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In an embodiment of the present invention the composition II does not comprise one or more C3-C4- alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II comprises i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

In an embodiment of the present invention the composition II comprises i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, wherein the ratio of the at least one HMO (component A) and the at least one phytosterol (component C) is 50:1 to 1 :100, preferably from 25:1 to 1 :50, even more preferably from 20:1 to 1 :30.

In another embodiment of the present invention the at least one HMO and the at least one phytosterol are present in synergistic amounts.

In an embodiment of the present invention said composition II does not comprise one or more C3- C4-alkane carboxylic acid or derivative(s) thereof. In an embodiment of the present invention the composition II comprises i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, wherein the ratio of the at least one HMO (component A) and the at least one phytosterol (component C) is from 50:1 to 1 :100, preferably from 25:1 to 1 :50, even more preferably from 20:1 to 1 :30, and/or wherein the ratio of the at least one HMO (component A) and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) is from 100:1 to 1 :100, preferably from 20:1 to 1 :20, more preferably 10:1 to 1 :10, even more preferably from 3:1 to 1 :3, in particular 2:1 to 1 :2, and/or wherein the ratio of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) and the at least one phytosterol (component C) is from 10: 1 to 1 : 100, preferably 5: 1 to 1 :50, even more preferably 2:1 to 1 :10.

In another embodiment of the present invention said composition II comprises as at least one C3- C4-alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100:1 to 1 :100, preferably from 20:1 to 1 :

20, more preferably from 10:1 to 1 :15, even more preferably from 2:1 to 1 :8.

In another embodiment of the present invention the at least one HMO and the at least one the phytosterol are present in synergistic amounts.

In another embodiment of the present invention the at least one HMO and the at least one C3-C4- alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.

In another embodiment of the present invention the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol are present in synergistic amounts.

In another embodiment of the present invention the at least one HMO, the at least one phytosterol and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.

In another embodiment of the present invention the total amount of the at least one HMO and the at least one phytosterol, and optionally the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 1 to 100 wt% of the total composition II, preferably from 10 to 100 wt%. In another embodiment the total amount of the at least one HMO is from 0.5 to 95 wt% of the total composition II, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%,%, in particular from 40 to 60 wt%. In yet another embodiment the total amount of the at least one HMO is from 0.5 to 50 wt% of the total composition II, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%. In yet another embodiment the total amount of the at least one HMO is from 50 to 95 wt% of the total composition II, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

In another embodiment the total amount of the at least one phytosterol is from 1 .0 to 95 wt% of the total composition I, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%,. In yet another embodiment the total amount of the at least one phytosterol is from 0.5 to 50 wt% of the total composition I, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%. In yet another embodiment the total amount of the at least one phytosterol is from 50 to 95 wt% of the total composition I, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

In another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 95 wt% of the total composition II, preferably from 10 to 90 wt%, more preferably from 15 to 85 wt%, even more preferably from 20 to 75 wt%, in particular from 25 to 60 wt%. In yet another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 50 wt% of the total composition II, preferably from 10 to 45 wt%, more preferably from 15 to 35 wt%. In yet another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 95 wt% of the total composition II, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

In another embodiment of the present invention the composition II can further comprise one or more vitamins or related compounds thereto. Examples of vitamins and related compounds thereto include vitamin A (e.g. retinol, retinyl acetate, retinyl palmitate, retinyl stearate, retinyl esters with other long-chain unsaturated fatty acids, retinal, retinoic acid and the like), vitamin B1 (e.g. thiamine, thiamine pyrophosphate, TPP, thiamine triphosphate, TTP, thiamine hydrochloride, thiamine mononitrate and the like), vitamin B2 (e.g. riboflavine, flavine mononucleotide (FMN), flavine adenine dinucleotide (FAD), lactoflavine, ovoflavine and the like), vitamin B3 (e.g. nicotinic acid, nicotinamide, nicotinamide adenine dinucleotide (NAD), nicotinic acid mononucleotide (NicMN), pyridine-3-carboxylic acid and the like, as well as the vitamin B3-precursor tryptophan), pantothenic acid (e.g. pantothenate, panthenol and the like), vitamin B6 (e.g. pyridoxine, pyridoxal, pyridoxamine, pyridoxine hydrochloride and the like), biotin, folic acid (e.g. folate, folacin, pteroylglutamic acid and the like), vitamin B12 (e.g. cobalamin, methylcobalamin. deoxyadenosyl- cobalamin, cyanocobalamin, hydroxycobalamin, adenosylcobalamin and the like), vitamin E (e.g. alpha-, beta-, gamma- and/or delta-tocopherol, alpha-, beta-, gamma- and/or delta-tocopherol acetate, alpha-, beta-, gamma- and/or delta-tocopherol succinate, alpha-, beta-, gamma- and/or delta-tocopherol nicotinate, alpha-, beta-, gamma- and/or delta tocotrienol and the like), vitamin K (e.g. vitamin K1 , phylloquinone, naphthoquinone, vitamin K2, menaquinone-7, vitamin K3, menaquinone-4, menadione, menaquinone-8, menaquinone-9, menaquinone-10, menaquinone-11 , menaquinone-12, menaquinone-13, and the like ), vitamin C (ascorbic acid), vitamin D (e.g. calciferol, cholecalciferol, 1 ,25-dihydroxyvitamin D, ergocalciferol and the like), and the like and/or mixtures thereof.

The presence and amounts of specific vitamins and/or related compounds thereto will vary depending on the intended use.

In a specific embodiment composition II does not comprise one or C3-C4-alkane carboxylic acid or derivative(s) thereof.

In a specific embodiment composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II does not comprise one or more vitamins or related compounds thereto.

In another embodiment of the present invention the composition II does comprise one or more vitamins or related compounds thereto.

In another embodiment of the present invention the composition II can further comprise one or more carotenoids. Examples of carotenoids include astaxanthin, alpha-carotene, beta-carotene, beta- cryptoxanthin, lutein, lycopene, meso-zeaxanthin, zeaxanthin and the like (including cis/trans isomers) and/or mixtures thereof. The presence and amounts of specific carotenoids will vary depending on the intended use.

In a specific embodiment composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s).

In a specific embodiment composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s).

In another embodiment of the present invention the composition II does not comprise one or more carotenoids. In another embodiment of the present invention the composition II can further comprise one or more medium-chain fatty acids. These medium-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or alkyl esters. Examples of medium-chain fatty acids include caproic acid, caprylic acid, capric acid, lauric acid and the like and /or mixtures thereof.

The presence and amounts of specific medium chain fatty acids will vary depending on the intended use.

In a specific embodiment composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In a specific embodiment composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II does not comprise one or more medium-chain fatty acids.

In another embodiment of the present invention the composition II can further comprise one or more long-chain fatty acids. These long-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or as alkyl esters. Examples of long chain fatty acids include saturated long chain fatty acids (e.g. myristic acid, palmitic acid, stearic acid, arachidic acid, behenic acid, lignoceric acid, cerotic acid and the like and/or mixtures thereof), mono-unsaturated long chain fatty acids (e.g. myristoleic acid, palmitoleic acid, sapienic acid, oleic acid, elaidic acid, vaccenic acid, erucic acid and the like and/or mixtures thereof), polyunsaturated long chain fatty acids (e.g. linoleic acid, linoelaidic acid, alpha-linolenic acid, arachidonic acid, eicosapentaenoic acid, docosapentenoic acid, docosahexaenoic acid and the like and/or mixtures thereof) and/or mixtures thereof. These long chain fatty acids are comprised for example in vegetable oils, single cell oils and marine oils, e.g. fish oil, krill oil and the like.

The presence and amounts of specific long chain fatty acids will vary depending on the intended use.

In a specific embodiment composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof. In a specific embodiment composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II does not comprise one or more long-chain fatty acids.

In another embodiment of the present invention the composition II can further comprise one or more prebiotics. Examples of prebiotics include water-insoluble fibers (e.g. lignin, cellulose, hemi- cellulose, resistant starch, xanthum gum and the like and/or mixtures thereof), water-soluble fibers (e.g. arabinoxylan, inulin, pectin, alginic acid and derivatives thereof, agar, carrageen, raffinose, xylose, polydextrose, lactulose, and the like and/or mixtures thereof), other oligosaccharides like xylooligosaccharides, fructooligosaccharides, galactooligosaccharides, isomalto-oligosaccharides and the like and/or mixtures thereof.

The presence and amounts of specific prebiotics will vary depending on the intended use.

In a specific embodiment composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In a specific embodiment composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II does not comprise one or more prebiotics.

In another embodiment of the present invention the composition II can further comprise one or more probiotics. Examples of probiotics optionally present in the composition II of the present invention include microorganisms or parts thereof of the family Lactobacillaceae, e.g. of the genus Lactobacillus (e.g. the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii (like lactobacillus delbrueckii spp. bulgaricus, lactobacillus delbrueckii spp. delbrueckii, lactobacillus delbrueckii spp. lactis), lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus rhamnosus, lactobacillus salivarius and the like), of the genus Bifidobacterium (e.g. the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum and the like), of the genus Pediococcus (e.g. the species pediococcus acidilactici, pediococcus pentosaceus and the like), of the genus Lactococcus (e.g. the species lactococcus lactis (like lactococcus latis spp. cremoris, lactococcus lactis spp. lactic and the like) and of the genus Streptococcus (e.g. the species streptococcus thermophilus and the like) and of the genus Faecalibacterium (e.g. the species faecalibacterium prausnitzii) and of the genus Bacillus (e.g. the species bacillus subtilis) and the like and/or mixtures thereof.

The presence and amounts of specific probiotics will vary depending on the intended use.

In a specific embodiment composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In a specific embodiment composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II does not comprise one or more probiotics.

In another embodiment of the present invention the composition II can further comprise one or more phenolic compounds. Examples of phenolic compounds include monophenols (e.g. apiole, carnosol, carvacrol, dillapiole, rosemarinol and the like), flavonoids (e.g. quercetin, kaempferol, myricetin, fisetin, rutin, isorhamnetin, hesperidin, naringenin, silybin, eriodyctiol, acacetin, apigenin, chrysin, diosmetin, tangeritin, luteolin, catechins like epigallocatechin gallate, theaflavin, thearubigins, proanthocyanidins, pelargonidin, peonidin, cyanidin, delphinidin, malvidin, petunidin and the like), isoflavonoids (e.g. daidzein, genistein, glycitein and the like), aurones, chalconoids, flavonolignans, lignans, phytoestrogens, stilbenoids (e.g. resveratrol, pterostilbene, piceatannol and the like), curcuminoids (e.g. curcumin and the like), tannins, aromatic acids (e.g. salicylic acid, vanillic acid, gallic acid, ellagic acid, tannic acid, caffeic acid, chlorogenic acid, cinnamic acid, ferulic acid, coumarin and the like), phenylethanoids (e.g. tyrosol, hydroxytyrosol, oleocanthal, oleuropein and the like ), capsaicin, gingerol, alkylresorcinol and the like and/or mixtures thereof.

The presence and amounts of specific phenolic compounds will vary depending on the intended use.

In a specific embodiment composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In a specific embodiment composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II does not comprise one or more phenolic compounds.

In another embodiment of the present invention the composition II can further comprise one or more herbals, e.g. known from Chinese diets, Indian diets, Mediterranean diets and the like. These herbals can be provided as powders obtained from the plant and/or fungus or parts thereof or as extracts thereof.

Examples for herbals known from Chinese diets include extracts or powders of hawthorn fruit, wolfberry, spatholobus stem, caterpillar fungus, cloud mushroom, crysanthemum, honeysuckle flower, mulberry leaf, glossy privet fruit, malaytea scurfpea fruit, cherokee rose fruit, palmleaf raspberry fruit, Chinese magnoliavine fruit, reishi mushroom, ephedra, epimedium, Angelica root, Astragalus root, rhubarb, licorice, morinda root, notoginseng, white peony root, American ginseng, fleeceflower root, kudzu root, rehmannia root, salvia root, Chinese yam, wild buckwheat rhizome, tall gastrodia tuber, golden root, Cassia seed, Coix seed, Dodder seed and the like and/or mixtures thereof.

Examples for herbals known from Indian diets include extracts or powders of Amalaki (Indian gooseberry), Haritaki (chebulic myrobalan), Bibhitaki (beleric), Haldi (turmeric), Tulsi (holy basil), Shigru (moringa), Twak (cinnamon), Yashtimadhu (licorice root), Dhanyaka (coriander), Ashwagandha (winter cherry), Kumkuma (saffron), Manjistha (Indian madder), Brahmi (bacopa), Neem (margosa), Ajwain (Bishop’s weed), Elaichi (cardamom), Shikakai (Acacia concinna), Shatavari (wild asparagus), Jeera (cumin), Guduchi (tinospora) and the like and/or mixtures thereof. Examples for herbals known from Mediterranean diets include extracts or powders of rosemary, basil, parsley, saffron, thyme, oregano, sage, cilantro, lemon, orange, grape, grapeseed, fig, blueberry, raspberry, strawberry, cherry, fennel, sesame seeds, pine seeds, garlic, onion, ginger root, pepper, chili and the like, olive oil and/or mixtures thereof.

The presence and amounts of specific herbals will vary depending on the intended use.

In a specific embodiment composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In a specific embodiment composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II does not comprise one or more herbals.

In another embodiment of the present invention the composition II can further comprise one or more minerals. Examples of minerals include such ones comprising calcium, phosphorous, iodine, iron, magnesium, copper, zinc, manganese, chlorine, potassium, sodium, selenium, chromium, molybdenum and the like and/or mixtures thereof. In an embodiment of the present invention the mineral does not comprise iron. Minerals are usually added in salt form.

The presence and amounts of specific minerals will vary depending on the intended use. In a specific embodiment composition II does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In a specific embodiment composition II does comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment of the present invention the composition II does not comprise one or more minerals.

In another embodiment of the present invention the composition I does not comprise one or more antibodies.

The compositions II of the present invention can be prepared by mixing the at least one HMO, and the at least one phytosterol, optionally the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally further components e.g. vitamins and related compounds thereto, carotenoids, medium chain fatty acids, long chain fatty acids, prebiotics, probiotics, phenolic compounds, herbals, minerals and the like and/or mixtures thereof, as known in the art. In an embodiment thereof the composition I does not comprise more than 80 wt% water.

Furthermore, the present invention provides a composition II which comprises i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for use as a medicament, preferably as a medicament for mammals and/or birds, in particular as a medicament for mammals.

For the purpose of the present invention, the term ’’mammals” encompasses humans and nonhuman mammals. Examples for non-human mammals are livestock, e.g. sheep, goats, pigs, cattles, horses, camels, llamas and the like, and pets, e.g. cats, dogs and the like.

In a preferred embodiment of the present invention the composition II is for use as a medicament for humans.

In another preferred embodiment of the present invention the composition II is for use as a medicament for livestock and/or pets. In another preferred embodiment of the present invention the composition II is for use as a medicament for birds, e.g. poultry (like chickens, ducks, geese, turkeys and the like) and ornamental birds (like canaries and the like).

The compositions II of the present invention for use as a medicament can be administered orally, enterally or parenterally, preferably orally.

In an embodiment of the present invention the composition II for use as a medicament is an orally administrable composition.

In another embodiment of the present invention the composition II comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and optionally iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for use as a medicament, preferably as a medicament for humans.

It is understood that the embodiments mentioned for the composition II shall be applicable for the compositions II for use as a medicament and the specific embodiments thereto.

Furthermore, the present invention provides a composition II which comprises i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the use in the treatment and/or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, preferably of mammals, more preferably of humans.

For the purpose of the present invention the term ’’treatment” in the context of (pre)hypercholesterolemia and/or associated morbidities thereto means using an effective therapy or management to alleviate, reduce or cure the condition and/or disease ((pre)hypercholesterolemia and/or associated morbidities thereto) and/or symptoms thereof, as the case may be, in addition it also includes the stabilization of the condition and/or disease, as the case may be, in order not to worsen in the course of the respective condition and/or disease. In an embodiment of the present invention treatment is understood as using an effective therapy or management to stabilize, alleviate or reduce the condition and/or disease and/or symptoms thereof, as the case may be.

Within the context of the present invention the term ’’prevention” in the context of (pre)hypercholesterolemia and/or associated morbidities thereto means an effective therapy or management so that the condition and/or disease ((pre)hypercholesterolemia and/or associated morbidities thereto) does not de novo develop, manifest and/or symptoms thereof do not occur.

In an embodiment of the present invention the composition II is for use in the treatment of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention the composition II is for use in the prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

For the purpose of the present invention the term ’’(pre)hypercholesterolemia” refers to a condition and/or disease, as the case may be, which is characterized by an abnormal and/or excessive increase of the level of total cholesterol in blood of a respective subject. In particular, a subject is considered as (pre)hypercholesterolemic in case the subject has pre-hypercholesterolemia or hypercholesterolemia, e.g with a level of total cholesterol in blood of 200 mg/ml_ or more.

Within the context of the present invention the term “pre-hypercholesterolemia” refers to a condition or disease wherein the respective subject shows a level of total cholesterol in the blood of 200 to 239 mg/dl_ and the term “hypercholesterolemia” refers to a condition or disease wherein the respective subject shows a level of total cholesterol in the blood of 240 mg/dl_ or more.

In an embodiment of the present invention the composition II is for use in the treatment or prevention of pre-hypercholesterolemia of a human.

In an embodiment of the present invention the composition II is for use in the treatment or prevention of hypercholesterolemia of a human.

For the purpose of the present invention the term “associated morbidities” as well as the term ’’morbidities associated to” mean one or more conditions and/or diseases which are co-occurring to the primary condition or disease ((pre)hypercholesterolemia), or which are occurring later in the life of the subject who had earlier in his or her life said primary condition and/or disease ((pre)hypercholesterolemia). In another embodiment of the present invention the composition II is for use in the treatment or prevention of an associated morbidity, e.g. an associated morbidity of the cardiovascular system, which includes atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure, deep vein thrombosis etc., an associated morbidity of the abdomen, which includes transient ischemic attack (which manifests as abdominal pain), intestinal embolism, renal failure etc., an associated morbidity of the brain and/or nerves, which includes transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure, stroke etc., an associated morbidity of the lungs, which includes transient ischemic attack (which manifests as chest pain), pulmonary embolism, respiratory failure etc., an associated morbidity of the eyes, which arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism, visual failure etc., an associated morbidity of the skin, which xanthelasma palpebarum etc., an associated morbidity of the tendons, which xanthomata etc., and the like, in particular of a human.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of an associated morbidity of the cardiovascular system, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of an associated morbidity of the abdomen, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of an associated morbidity of the brain and/or nerves, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia. In another embodiment of the present invention the composition II is for use in the treatment or prevention of transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke, in particular of a human subject having pre-hyper- cholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of an associated morbidity of the lungs, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of an associated morbidity of the eyes, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of an associated morbidity of the skin, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of xanthelasma palpebarum, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II is for use in the treatment or prevention of an associated morbidity of the tendons, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia. In another embodiment of the present invention the composition II is for use in the treatment or prevention of xanthomata, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition II for use in the treatment or prevention of (pre)hypercholesterolemia is an orally, enterally or parenterally, preferably orally administrable composition, in particular for a human subject.

In another embodiment of the present invention the composition II for use in the treatment or prevention of morbidities associated to (pre)hypercholesterolemia is an orally, enterally or parenterally, preferably orally administrable composition, in particular for a human subject.

In an embodiment of the present invention the composition II comprises i) at least one HMO, and ii) at least one phytosterol, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of a mammal, especially pre-hypercholesterolemia of a human or especially of hypercholesterolemia of a human or especially of morbidities associated to (pre)hypercholesterolemia of a human.

In another embodiment of the present invention the composition II comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto of a mammal, in particular of pre-hypercholesterolemia of a human, or in particular of hypercholesterolemia of a human, or in particular of morbidities associated to (pre)hypercholesterolemia of a human.

In an embodiment of the present invention the composition II for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of a mammal, especially of pre-hypercholesterolemia of a human or especially of hypercholesterolemia of a human or especially of morbidities associated to (pre)hypercholesterolemia of a human, does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof. In another embodiment of the present invention the composition II comprises i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto of a mammal, in particular of pre-hypercholesterolemia of a human, or in particular of hypercholesterolemia of a human or in particular of morbidities associated to (pre)hypercholesterolemia of a human.

In another embodiment of the present invention the composition II comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto of a mammal, in particular of pre-hypercholesterolemia of a human, or in particular of hypercholesterolemia of a human or in particular of morbidities associated to (pre)hypercholesterolemia of a human.

It is understood that the embodiments mentioned for the composition II shall be applicable for the compositions II for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto and the specific embodiments thereto.

Furthermore, the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof. In an embodiment of the invention said method is for treating a subject having prehypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention said method is for treating a subject having hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention said method is for treating a subject having morbidities associated to (pre)hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to (pre)hyper- cholesterolemia, in particular a human.

In another embodiment of the invention said human subject is in the age of 12 years or older, preferably 18 years or older, more preferably 35 years or older, in particular 50 years or older, even more particular 60 years or older.

It is understood that in this method the composition II can be administered, preferably orally, or that any of the “at least one HMO” and the “at least one phytosterol” and optional the “at least one C3- C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components can be administered separately, preferably orally. Furthermore it is understood that in case composition II comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally, and in case composition II comprises as the at least one phytosterol two or more phytosterols these can be administered separately, preferably orally, and in case composition II comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3- C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally.

In an embodiment thereof, the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.

In another embodiment the daily application rate of the at least one phytosterol is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1.5 to 3.0 g.

In another embodiment thereof, the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g. In another embodiment thereof, the propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.

In a further embodiment thereof, the butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1 .0 to 5.0 g/day.

In another embodiment the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g, preferably the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g, more preferably the daily application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 1 .5 to 4.0 g.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) at least one HMO, and ii) at least one phytosterol.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of said composition II which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition II which comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

It is understood that the embodiments mentioned for the composition II shall be applicable for the use of the composition II in this method accordingly and in the specific embodiments thereto.

Furthermore, the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto. In an embodiment the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one phytosterol, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the invention the medicament manufactured as mentioned above is for treating a subject having pre-hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention the medicament manufactured as mentioned above is for treating a subject having hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention the medicament manufactured as mentioned above is for treating a subject having morbidities associated to (pre)hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, in particular a human.

It is understood that the embodiments mentioned for the composition II shall be applicable for the use of the composition II in this use accordingly and in the specific embodiments thereto.

Furthermore, the present invention provides a nutritional supplement comprising a composition II which comprises i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

For the purpose of the present invention the term “nutritional supplement” means a manufactured product intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of (pre)hypercholesterolemia and/or associated morbidities thereto. Examples for nutritional supplements include “dietary supplements” and “medical foods”. A dietary supplement is intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, however it needs not to be used under medical supervision. A medical food is also intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, but it is under medical supervision. The terms “medical foods” and “food for special medical purpose” are interchangeable. It is understood that the nutritional supplement can comprise said composition II or that the nutritional supplement can comprise any of the “at least one HMO” and the “at least one phytosterol” and optional the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components in separate form.

In an embodiment of the present invention the nutritional supplement is a dietary supplement.

In another embodiment of the present invention the nutritional supplement is a medical food.

In an embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment thereof, the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.

In another embodiment the daily application rate of the at least one phytosterol is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1.5 to 3.0 g.

In another embodiment thereof, the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g. Preferably, propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day. Preferably butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day. In another embodiment the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g, preferably the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g, more preferably the daily application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 1 .5 to 4.0 g.

In another embodiment of the invention said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years or older.

It is understood that in this method the nutritional supplement can be administered, preferably orally, or that any of the “at least one HMO” and the “at least one phytosterol” and the optional “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components can be administered separately, preferably orally. Furthermore it is understood that in case the nutritional supplement comprises as at least one HMO two or more HMOs that these can be administered separately, preferably orally, and in case the nutritional supplement comprises as at least one phytosterol two or more phytosterols that these can be administered separately, preferably orally, and in case the nutritional supplement comprises as at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof that these can be administered separately, preferably orally.

Furthermore, the present invention provides a nutritional supplement comprising a composition II which comprises i) at least one HMO, and ii) at least one phytosterol, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a nutritional supplement comprising a composition II which comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In another embodiment the present invention provides a nutritional supplement comprising a composition II which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a nutritional supplement comprising a composition II which comprises i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a nutritional supplement comprising a composition II which comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition II as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the nutritional supplement accordingly and as well as to the specific embodiments thereto.

Furthermore, the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia. It is understood that the nutritional supplement can comprise said composition II or that the nutritional supplement can comprise any of the “at least one HMO” and the “at least one phytosterol” and optional the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components in separate form. Furthermore, it is understood that in case composition II comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally, and in case composition II comprises as the at least one phytosterol two or more phytosterols these can be administered separately, preferably orally, and in case composition II comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3- C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) at least one HMO, and ii) at least one phytosterol.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia. In another embodiment the present invention said method supplement is for the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia. In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition II as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the use of the nutritional supplement in this method accordingly as well as in the specific embodiments thereto.

Furthermore, the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one phytosterol, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk o7 developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto. In another embodiment the present invention provides the use of a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of subjects having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having pre-hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human. In an embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having or being suspected of having or being at risk of developing a morbidity associated to (pre)hypercholesterolemia, in particular a human.

It is understood that the embodiments mentioned for the composition II shall be applicable for the use of the composition II in this use accordingly and in the specific embodiments thereto.

Both, the medicament (in general and for the respective specific use) and the nutritional supplement (in general and for the respective specific use) of the present invention can be delivered in any suitable format. Formulations suitable for oral administration may be in the form of capsules, tablets, pills, dragees, lozenges (using a flavored basis, usually sucrose and acacia or tragacanth), powders, granules, and the like or as a solution or a suspension in an aqueous or non-aqueous liquid, or as an oil-in-water or water-in-oil liquid emulsion, or as an elixir or syrup, or as pastilles (using an inert base, such as gelatin and glycerin, or sucrose and acacia), each comprising a predetermined amount of the at least one HMO, the at least one phytosterol, optional the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and optional further components. The medicament (in general and for the respective specific use) and/or the nutritional supplement (in general and for the respective specific use) of the present invention may also be administered as a bolus, electuary or paste.

It is understood that the active ingredients of said medicament and nutritional supplement can be delivered together in a respective suitable format or that each of component A and component C and optionally component B can be delivered in a respective format or that each of the active ingredients can be delivered in a respective format, or any combination thereof.

In solid dosage forms for oral administration (capsules, tablets, pills, dragees, lozenges, powders, granules, and the like), the desired components of the composition II may be mixed with one or more pharmaceutically acceptable carriers, such as sodium citrate or dicalcium phosphate, and/or any of the following: (1) fillers or extenders, such as starches, lactose, sucrose, glucose, mannitol, and/or silicic acid; (2) binders, such as carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone, sucrose and/or acacia; (3) humectants, such as glycerol; (4) disintegrating agents, such as agar- agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate; (5) solution retarding agents, such as paraffin; (6) absorption accelerators, such as quaternary ammonium compounds; (7) wetting agents, such as acetyl alcohol and glycerol monostearate; (8) absorbents, such as kaolin and bentonite clay; (9) lubricants, such a talc, calcium stearate, magnesium stearate, solid polyethylene glycols, sodium lauryl sulfate, and mixtures thereof; (10) coloring agents; and (11) flavors, such as lemon, orange, apricot, banana, cherry, strawberry, raspberry, blueberry, peppermint, vanilla, chocolate, coffee, cappuccino flavor and the like. In some cases, the compositions II may also comprise buffering agents.

In a specific embodiment, powders and/or granules can be reconstituted with water or another aqueous liquid prior to consumption.

In a particular embodiment the so obtained liquid does not comprise more than 80 wt% water.

In another embodiment such above-mentioned liquid formulations do not comprise more than 80 wt% water.

Furthermore, the present invention provides a functional food comprising a composition II which comprises i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

For the purpose of the present invention the term “functional food” means a food which is fortified with the composition II according to the present invention and intended to be used in a diet, in particular of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto. The terms “functional food” and “fortified food” are interchangeable.

Examples for foods being suitable for the preparation of functional foods are (1) dairy products e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) bakery products e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) candy products e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) beverage products e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.

It is understood that the functional food can comprise said composition II or that the functional food can comprise any of the “at least one HMO” and the “at least one phytosterol” and optional the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components in separate form. Furthermore it is understood that in case the composition II comprises as the at least one HMO two or more HMOs these can be comprised separately in the functional food or together as composition, and in case the composition II comprises as the at least one phytosterol compound two or more phytosterols these can be comprised separately in the functional food or together as composition, and in case the composition II comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be comprised separately in the functional food or together as composition.

In an embodiment of the present invention the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing pre hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the present invention the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the present invention the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment thereof, the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.

In another embodiment the daily application rate of the at least one phytosterol is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1.5 to 3.0 g.

In another embodiment thereof, the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g. Preferably, propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day. Preferably butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day. In another embodiment the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g, preferably the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g, more preferably the daily application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g.

In another embodiment of the invention said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years and older.

In an embodiment the present invention provides a functional food comprising a composition II which comprises i) at least one HMO, and ii) at least one phytosterol, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a functional food comprising a composition II which comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a functional food comprising a composition II which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a functional food comprising a composition II which comprises i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof. In another embodiment the present invention provides a functional food comprising a composition II which comprises i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

In another embodiment of the present invention said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition II as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the functional food accordingly as well as to the specific embodiments thereto.

Furthermore, the present invention provides a method for the dietary management of a subject having, being suspected to have or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia. In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the “at least one HMO” and the “at least one phytosterol” and optional the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional further components can be comprised separately in the functional food or together as composition. Furthermore it is understood that in case the composition II comprises as at least one HMO two or more HMOs that these can be comprised separately in the functional food or together as composition, and in case the composition II comprises as at least one phytosterol two or more phytosterols that also these can be comprised separately in the functional food or together as composition, and in case the composition II comprises as at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3- C4-alkane carboxylic acid or derivative(s) thereof that also these can be comprised separately in the functional food or together as composition.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II comprising i) at least one HMO, and ii) at least one phytosterol.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of a functional food which comprises a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol. In another embodiment the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate. In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition II as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the use of the functional food in this method accordingly as well as in the specific embodiments thereto.

Furthermore, the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one phytosterol, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II, which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II comprising i) at least one HMO, and ii) at least one phytosterol, and iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, for the manufacture of afunctional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition II comprising i) as component A 2’-FL, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the invention the functional food manufactured as mentioned above is for the dietary management of a subject having pre-hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention the functional food manufactured as mentioned above is for the dietary management of a subject having hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having morbidities associated to (pre)hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, in particular a human. It is understood that the embodiments mentioned for the composition II shall be applicable for the use of the composition II in this use accordingly and in the specific embodiments thereto.

The functional food of the present invention can be prepared by known techniques and it can have any suitable type of format such as (1) a dairy product e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) a bakery product e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) a candy product e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) a beverage product e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.

Furthermore, it is contemplated herein that the composition II, the composition II for use as a medicament, the composition II for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, the nutritional supplement and the functional food, in particular for use in the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto, respectively, as disclosed herein, can be co-administered to subjects receiving at least one pharmaceutical against said (pre)hypercholesterolemia and/or associated morbidities thereto. Examples for pharmaceuticals used in the treatment of (pre)hypercholesterolemia are:

- lipid-lowering medications (statins, fibrates, nicotinic acid, cholestyramine and the like)

- immunomodulators (evolocumab, bococizumab, alirocumab and the like).

Furthermore, the present invention provides a method to treat a subject having (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject a) an effective amount of a composition II, a composition II for use as a medicament, a composition II for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, a nutritional supplement or a functional food, in particular for use in the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto, which comprises i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof; and b) an effective amount of at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, in particular, wherein the application rate of the at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone. In an embodiment thereof the (pre)hypercholesterolemia and/or associated morbidities thereto is (pre)hypercholesterolemia and the pharmaceutical is

- lipid-lowering medications (statins, fibrates, nicotinic acid, cholestyramine and the like)

- immunomodulators (evolocumab, bococizumab, alirocumab and the like).

Furthermore, the present invention provides a composition comprising a) i) at least one HMO, and/or ii) at least one phytosterol, and/or iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof; and b) an effective amount of at least one pharmaceutical, in particular for use as a medicament, especially for use in the treatment of (pre)hyper- cholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) i) as component A 2’-FL, and/or ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and/or iii) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate; and b) lipid-lowering medications (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) as component A at least one HMO, preferably 2’-FL, and b) a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, without anyphytosterol, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and b) a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like)in a pharmaceutical effective amount, without any HMO, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and b) a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, without any without HMO and/or without C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hyper- cholesterolemia and/or associated morbidities thereto.

It is understood that the embodiments mentioned for the components and for the diseases and the symptoms mentioned above shall apply here to.

In particular, the composition II, the composition II for use as a medicament, the composition II for use in the treatment or prevention of (pre)hypercholesterolemia, the nutritional supplement or a functional food, in particular for use in the dietary management of (pre)hypercholesterolemia, used in said method comprises - 2’-FL, and/or at least one of sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol, and/or propionic acid and/or butyric acid or derivative(s) thereof, preferably 2’-FL, sitosterol, in particular beta-sitosterol, and/or campesterol, and/or optionally preferably sodium propionate and sodium butyrate.

In another embodiment the composition II, the composition II for use as a medicament, the composition II for use in the treatment or prevention of a morbidity associated to (pre)hypercholesterolemia, the nutritional supplement or a functional food, in particular for use in the dietary management of a morbidity associated to (pre)hypercholesterolemia, used in said method comprises

- 2’-FL, and/or at least one of sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol, and/or propionic acid and/or butyric acid or derivative(s) thereof, preferably 2’-FL, sitosterol, in particular beta-sitosterol, and/or campesterol, and/or optionally preferably sodium propionate and sodium butyrate.

In an embodiment of the present invention the nutritional supplement or the functional food is for use in the dietary management of pre-hypercholesterolemia.

In an embodiment of the present invention the nutritional supplement or the functional food is for use in the dietary management of hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of a morbidity associated to (pre)hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the cardiovascular system, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the abdomen, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia .

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia .

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of brain and/or nerves, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia .

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the lungs, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia. In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the eyes, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the skin, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of xanthelasma palpebarum, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the tendons, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of xanthomata, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

Furthermore, the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising at least one HMO and a second component comprising at least one phytosterol and optionally a third component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In an embodiment the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, and a second component comprising sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5- avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta- sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and optionally a third component comprising propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

In another embodiment the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising 2’-FL, a second component comprising sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7- stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5- avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta- sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and a third component comprising propionic acid or derivative(s) thereof, preferably sodium propionate and a forth component comprising butyric acid or derivative(s) thereof, preferably sodium butyrate.

In another embodiment the present invention provides said kit for the pharmaceutical use for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto or for the dietary management use of the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides said kit for the pharmaceutical use for the treatment or prevention of pre-hypercholesterolemia or for the dietary management use of the dietary management of pre-hypercholesterolemia. In another embodiment the present invention provides said kit for the pharmaceutical use or dietary management use for the treatment or prevention of hypercholesterolemia or dietary management use for the dietary management of hypercholesterolemia.

In another embodiment the present invention provides said kit for the pharmaceutical use for the treatment or prevention of morbidities associated to (pre)hypercholesterolemia or for the dietary management use of the dietary management of associated morbidities to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the components A, C and B shall be applicable for the kit accordingly and in the specific embodiments thereto.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one HMO, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and optionally a third component comprising at least one phytosterol.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is 2’-FL, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, and optionally a third component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta- sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one phytosterol, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and optionally a third component comprising at least one HMO.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta- sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, and optionally a third component which is 2’-FL.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and optionally a third component comprising at least one HMO and/or at least one phytosterol.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is propionic acid and/or butyric acid or derivative(s) thereof, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, and optionally a third component 2’-FL, and/or optionally a third component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta- sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one HMO and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and a third component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and a forth component comprising at least one phytosterol.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is 2’-FL, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, a third component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and a forth component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta- sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

It is understood that the embodiments mentioned for the components A, B and C as well as for the diseases shall be applicable for the kit accordingly and in the specific embodiments thereto.

Within the context of the present invention, the term "butyric acid" denotes n-butyric acid and the term “butyrate” denotes n-butyrate. Also within the content of the present invention, the term ”at least one HMO” is interchangeable with the term ’’component A”, and the term ”at least one C3-C4-alkane carboxylic acid or a derivative thereof’ is interchangeable with the term “component B”, and the term “at least one phytosterol” is interchangeable with the term “component C”.

Wthin the context of the present application, it is noted that in case a composition comprises several components that these can also be administered separately. However, this means that such components can be administered together or separately, as the case may be.

Also, within the context of the present invention, ratios given are weight to weight ratios unless stated otherwise. The weight unit “meg” stands for micro gram. In addition, in the context of the invention, the terms "comprising" or "comprises" do not exclude other possible elements. The composition of the present invention, including the embodiments described herein, can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise depending on the needs. The terminology as set forth herein is for description of the embodiments only and should not be construed as limiting the disclosure as a whole. In a particular embodiment the compositions of the invention consist essentially of the essential elements, and even more particular consist of the essential elements. Furthermore, as used in the description and the appended claims, the singular forms "a", "an", and "the" are inclusive of their plural forms, and the other way around, unless the context clearly indicates otherwise. It is to be understood that the embodiments of the subject matter of the invention can be applied in the specific context but also in other combinations, without leaving the scope of the invention. E.g. it is understood that the embodiments mentioned for the composition of the present invention also apply for composition for use as a medicament, etc. The same applies for the respective conditions and/or diseases.

In the following specific embodiments II of the present invention are described. 1-11. A composition II comprising i) at least one HMO, and ii) at least one phytosterol, and optionally iii) at least one C3-C4-alkane carboxylic acid or a derivative thereof.

2-11. The composition II according to embodiment 1-11, wherein one of the at least one HMO’s is a fucosylated oligosaccharide.

3-11. The composition II according to embodiment 1-11 or 2-11, wherein one of the at least one HMO is 2’-fucosyllactose (2’-FL).

4-11. The composition II according to any one of embodiments 1-11 to 3-11, wherein one of the at least one HMO’s is a sialylated oligosaccharide.

5-11. The composition II according to any one of embodiments embodiment 1-11 to 4-11, wherein one of the at least one HMO is 6’-sialyllactose (6’-SL).

6-11. The composition II according to any one of embodiments 1-11 to 5-11, wherein one of the at least one HMO’s is a N-acetylated oligosaccharide.

7-11. The composition II according to any one of embodiments 1-11 to 6-11, wherein one of the at least one HMO is lacto-N-tetraose (LNT).

8-11. The composition II according to any one of embodiments 1-11 to 7-11, wherein the at least one

HMO is one or more HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyllactose (in particular 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL.

9-11. The composition II according to any one of embodiments 1-11 to 8-11, wherein the at least one

HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyllactose (in particular 2’, 2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL.

10-11. The composition II according to any one of embodiments 1-11 to 9-11, wherein the at least one

HMO is one, two or three HMOs selected from the group consisting of 2’-FL, LNT, LNnT, 3’-SL and 6’-SL.

11-11. The composition II according to any one of embodiments 1-11 to 9-11, wherein the at least one

HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 2’,2”-DiFL and 3,2’-DiFL. 12-11. The composition II according to any one of embodiments 1-11 to 11-11 wherein the at least one

HMO is 2’-FL.

13-11. The composition II according to any one of embodiments 1-11 to 12-11, wherein the at least one phytosterol is at least one of plant sterols or plant stanols, wherein said plant sterols and/or said plant stanols are present in free form and/or in ester form.

14-11. The composition II according to embodiment 1-11 to 13-11, wherein the plant sterol and the plant stanol is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5- avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol.

15-11. The composition II according to any one of embodiments 1-11 to 14-11, wherein wherein the plant sterol and the plant stanol is a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol.

16-11. The composition II according to any one of embodiments 1-11 to 15-11, wherein the plant sterol and the plant stanol is a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

17-11. The composition II according to any one of embodiments 1-11 to 16-11 which does not comprise one or more C3-C4-alkane carboxylic acid or derivative(s) thereof.

18-11. The composition II according to any one of embodiments 1-11 to 16-11 which comprise at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

19-11. The composition II according to any one of embodiments 1-11 to 18-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof.

20-11. The composition II according to any one of embodiments 1-11 to 19-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of propionic acid. 21-11. The composition II according to any one of embodiments 1-11 to 20-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of propionic acid.

22-11. The composition II according to any one of embodiments 1-11 to 21-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium salt of propionic acid.

23-11. The composition II according to any one of embodiments 1-11 to 22-11 wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate.

24-11. The composition II according to any one of embodiments 1-11 to 20-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid.

25-II. The composition II according to any one of embodiments 1-11 to 24-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is butyric acid or a derivative thereof.

26-11. The composition II according to any one of embodiments 1-11 to 25-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of butyric acid.

27-11. The composition II according to any one of embodiments 1-11 to 26-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of butyric acid.

28-11. The composition II according to any one of embodiments 1-11 to 27-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium salt of butyric acid.

29-11. The composition II according to any one of embodiments 1-11 to 28-11 wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium butyrate.

30-11. The composition II according to any one of embodiments 1-11 to 26-11, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of butyric acid. 31-11. The composition II according to any one of embodiments 1-11 to 30-11, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof and butyric acid or a derivative thereof.

32-11. The composition II according to any one of embodiments 1-11 to 31-11, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt of propionic acid and physiologically acceptable salt of butyric acid.

33-11. The composition II according to any one of embodiments 1-11 to 32-11, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of propionic acid and an alkali salt or an alkaline earth salt of butyric acid.

34-11. The composition II according to any one of embodiments 1-11 to 33-11, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium salt of propionic acid and a sodium or potassium salt of butyric acid.

35-11. The composition II according to any one of embodiments 1-11 to 34-11 wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate and sodium or potassium butyrate.

36-11. The composition II according to any one of embodiments 1-11 to 31-11, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable ester of propionic acid and a physiologically acceptable ester of butyric acid.

37-11. The composition II according to any one of embodiments 1-11 to 36-11, wherein the at least one

C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid and a C1 -C6 alkyl ester or a mono- or diglyceride of butyric acid.

38-II. The composition II according to any one of embodiments 1-11 to 37-11, wherein the weight to weight ratio of the at least one HMO (component A) : the at least one phytosterol (component C) is from 50:1 to 1 :100, preferably from 25:1 to 1 :50, more preferably from 20.1 to 1 :30.

39-II. The composition II according to any one of embodiments 1-11 to 38-11, wherein the weight to weight ratio of the at least one HMO (component A) : the at least one C3-C4 alkane carboxylic acid or a derivative thereof (component B) is from 100:1 to 1 : 100. 40-II. The composition II according to any one of embodiments 1-11 to 39-11, wherein the weight to weight ratio of (component A) : (component B) is from 20:1 to 1 :20, preferably from 10:1 to 1 :10, more preferably from 3:1 to 1 :3, in particular from 2:1 to 1 :2.

41-11. The composition II according to any one of embodiments 31-11 to 40-11, wherein the weight to weight ratio of the propionic acid or a derivative thereof : butyric acid or a derivative thereof is from 100:1 to 1 : 100.

42-II. The composition II according to any one of embodiments 31-11 to 41-11, wherein the weight to weight ratio of the propionic acid or a derivative thereof : butyric acid or a derivative thereof is from 20:1 to 1 :20, preferably from 10:1 to 1 :15, more preferably from 2:1 to 1 :8.

43-II. The composition II according to any one of embodiments 1-11 to 42-11, wherein the weight to weight ratio of (component B) : (component C) is from 10:1 to 1 : 100, preferably from 5:1 to 1 :50, even more preferably from 2:1 to 1 :10.

44-II. The composition II according to any one of embodiments 1-11 to 43-11, wherein the at least one

HMO and the at least one phytosterol are present in synergistic amounts.

45-11. The composition II according to any one of embodiments 1-11 to 44-11, wherein the at least one

HMO and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.

46-11. The composition II according to any one of embodiments 1-11 to 45-11, wherein the at least one phytosterol and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.

47-11. The composition II according to any one of embodiments 1-11 to 46-11, wherein the at least one

HMO and the at least one phytosterol and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof are present in synergistic amounts.

48-11. The composition II according to any one of embodiments 1-11 to 47-11, wherein the total amount of the at least one HMO and the at least one phytosterol and optionally the at least one C3- C4-alkane carboxylic acid or derivative(s) thereof is from 1 to 100 wt% of the total composition II, preferably from 10 to 100 wt%.

49-II. The composition II according to any one of embodiments 1-11 to 48-11, wherein the total amount of the at least one HMO is from 0.5 to 95 wt% of the total composition II, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%.

50-II. The composition II according to any one of embodiments 1-11 to 48-11, wherein the total amount of the at least one HMO is from 0.5 to 50 wt% of the total composition II, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%.

51-11. The composition II according to any one of embodiments 1-11 to 49-11, wherein the total amount of the at least one HMO is from 50 to 95 wt% of the total composition II, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

52-11. The composition II according to any one of embodiments 1-11 to 51-11, wherein the total amount of the at least one phytosterol is from 1.0 to 95 wt% of the total composition II, preferably from

10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%, or wherein the total amount of the at least one phytosterol is from 0.5 to 50 wt% of the total composition II, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%, or wherein the total amount of the at least one phytosterol is from 50 to 95 wt% of the total composition II, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

53-II. The composition II according to any one of embodiments 1-11 to 52-11, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 95 wt% of the total composition II, preferably from 10 to 90 wt%, more preferably from 15 to 85 wt%, even more preferably from 20 to 75 wt%, in particular from 25 to 60 wt%.

54-II. The composition II according to any one of embodiments 1-11 to 52-11, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 50 wt% of the total composition II, preferably from 10 to 45 wt%, more preferably from 15 to 35 wt%..

55-II. The composition II according to any one of embodiments 1 to 52-II, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 90 wt% of the total composition II, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

56-II. The composition II according to any one of embodiments 1-11 to 55-11, wherein the composition

11 further comprises one or more vitamins or related compounds thereto.

57-11. A composition II according to embodiment 56-11, wherein the one or more vitamins or related compounds thereto are selected from the group of vitamin A, vitamin B1 , vitamin B2, vitamin B3, pantothenic acid, vitamin B6, biotin, folic acid, vitamin B12, vitamin E, vitamin K, vitamin C and vitamin D, or related compounds thereto and/or mixtures thereof.

58-II. The composition II according to embodiment 57-I, wherein the composition II further comprises one or more carotenoids.

59-II. The composition II according to embodiment 58-II, wherein the one or more carotenoids are selected from the group of astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lutein, lycopene, meso-zeaxanthin, zeaxanthin and the like (including cis/trans isomers) and/or mixtures thereof.

60-II. The composition II according to any one of embodiments 1-11 to 59-11, wherein the composition

II further comprises one or more medium-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof.

61-11. The composition II according to embodiment 60-11, wherein the one or more medium chain fatty acids are selected from the group of caproic acid, caprylic acid, capric acid, lauric acid and/or mixtures.

62-11. The composition II according to any one of embodiments 1-11 to 61-11, wherein the composition

II further comprises one or more long-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof.

63-11. The composition II according to embodiment 62-11, wherein the one or more long chain fatty acids are selected from the group of saturated long chain fatty acids, mono-unsaturated long chain fatty acids, polyunsaturated long chain fatty acids and/or mixtures thereof.

64-11. The composition II according to any one of embodiments 1-11 to 63-11, wherein the composition

II further comprises one or more prebiotics.

65-11. The composition II according to embodiment 64-11, wherein the one or more prebiotics are selected from the group of water-insoluble fibers, water-soluble fibers or oligosaccharides, preferably xylooligosaccharides, fructooligosaccharides, galactooligosaccharides and/or isomalto-oligosaccharides, and/or mixtures thereof.

66-11. The composition II according to any one of embodiments 1-11 to 65-11, wherein the composition

II further comprises one or more probiotics. 67-II. The composition II according to embodiment 66-II, wherein the one or more probiotics are selected from the group of the family Lactobacilaceae, preferably of the genus Lactobacillus, in particular of the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii, lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus rhamnosus, lactobacillus salivarius, of the genus Bifidobacterium, in particular of the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum, of the genus Pediococcus, in particualar of the species pediococcus acidilactici, pediococcus pentosaceus, of the genus Lactococcus, in particular of the species lactococcus lactis, of the genus Streptococcus, in particular of the species streptococcus thermophilus, of the genus Faecalibacterium, in particular of the species faecalibacterium prausnitzii, of the genus Bacillus, in particular of the species bacillus subtilis, and/or mixtures thereof.

68-II. The composition II according to any one of embodiments 1-11 to 67-11, wherein the composition

II further comprises one or more phenolic compounds.

69-11. The composition II according to embodiment 68-11, wherein the one or more phenolic compounds are selected from the group of monophenols, flavonoids, isoflavonoids, aurones, chalconoids, flavonolignans, lignans, phytoestrogens, stilbenoids, piceatannol, curcuminoids, tannins, aromatic acids, phenylethanoids, capsaicin, gingerol, alkylresorcinol and/or mixtures thereof.

70-11. The composition II according to any one of embodiments 1-11 to 69-11, wherein the composition

II further comprises one or more herbals.

71-11. The composition II according to embodiment 70-11, wherein the one or more herbals are selected from herbals known from Chinese diets, Indian diets, Mediterranean diets and/or mixtures thereof.

72-11. The composition II according to any one of embodiments 1-11 to 71-11, wherein the composition

II further comprises one or more minerals.

73-11. The composition II according to any one of embodiments 1-11 to 72-11, wherein the composition does not comprise an antibody.

74-11. A composition II as described in any one of the embodiments 1-11 to 73-11 for use as a medicament, preferably as a medicament for mammals and/or birds, more preferably for mammals, even more preferably for humans. 75-II. A composition II as described in any one of embodiments 1-11 to 723-11 for use in the treatment and/or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans.

76-11. The composition II according to embodiment 75-11, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is pre-hypercholesterolemia, in particular of a human.

77-11. The composition II according to embodiment 75-11, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is a hypercholesterolemia, in particular of a human.

78-11. The composition II according to embodiment 75-11, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is an associated morbidity, in particular of a human.

79-11. A composition II as described in any one of embodiments 1-11 to 78-11, wherein the associated morbidity is an associated morbidity of the cardiovascular system, an associated morbidity of the abdomen, an associated morbidity of the brain and/or nerves or an associated morbidity of the lungs, an associated morbidity of the eyes, an associated morbidity of the skin, or an associated morbidity of the tendons, in particular a human, even more particular a human having (pre)hypercholesterolemia.

80-11. A composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain, cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia.

81-11. A composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia.

82-11. A composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. 83-II. A composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia.

84-11. A composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia.

85-11. A composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is xanthelasma palpebarum of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia.

86-11. A composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is xanthomata of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia.

87-11. The composition II according to any one of embodiments 74-11 to 86-11, wherein the composition II is an orally administrable composition.

88-11. A method for treating a subject having, suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto comprising administering to the subject an effective amount of a composition II according to any one of embodiments 1-11 to 73-11.

89-11. The method according to embodiment 88-11, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing (pre)hypercholesterolemia.

90-11. The method according to embodiment 88-11, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

91-11. The method according to any one of embodiments 88-11 to 90-11, wherein the application rate of the at least one HMO is from 0.1 to 20.0 g/day, preferably from preferably from 1.0 to 15.0 g/day, more 2.0 to 10.0 g/day, in particular from 2.5 to 5.0 g/day. 92-II. The method according to any one of embodiments 88-II to 91-11, wherein the application rate of at least one phytosterol is from 0.5 to 10.0 g, preferably from 1 .0 to 5.0 g, in particular from 1.5 to 3.0 g per day.

93-II. The method according to any one of embodiments 88-II to 92-II, wherein the application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g/day, preferably from 1.0 to 9.0 g/day, more preferably from 1.2 to 9.0 g/day, in particular from 2.0 to 8.0 g/day, especially from 2.5 to 6.0 g/day.

94-II. The method according to any one of embodiments 88-II to 93-II, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is propionic acid or a derivative thereof and is applied at a rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1.0 to 4.0 g/day.

95-II. The method according to any one of embodiments 88-II to 94-II, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is butyric acid and/or a derivative thereof and is applied at a rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.

96-II. The method according to any one of embodiments 88-II to 95-II, wherein the at least one C3-

C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day.

97-II. The method according to any one of embodiments 88-II to 96-II, wherein the composition II is administered orally.

98-II. A nutritional supplement or a functional food comprising a composition II according to any one of embodiments 1-11 to 73-11.

99-11. The nutritional supplement or the functional food according to embodiment 98-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans.

100-11. The nutritional supplement or functional food according to embodiment 99-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia, in particular pre-hypercholesterolemia or in particular hypercholesterolemia, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans.

101-11. The nutritional supplement or functional food according to embodiment 99-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans.

102-11. The nutritional supplement or functional food according to embodiment 101-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing an associated morbidity of the cardiovascular system, an associated morbidity of the abdomen, an associated morbidity of the brain and/or nerves, an associated morbidity of the eyes, an associated morbidity of the skin or an associated morbidity of the tendons, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

103-11. The nutritional supplement or functional food according to embodiment 102-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

104-11. The nutritional supplement or functional food according to embodiment 102-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

105-11. The nutritional supplement or functional food according to embodiment 102-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

106-11. The nutritional supplement or functional food according to embodiment 102-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

107-11. The nutritional supplement or functional food according to embodiment 102-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

108-11. The nutritional supplement or functional food according to embodiment 102-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing xanthelasma palpebarum, in particular of a human, even more particular of a human having (pre)hypercholesterolemia.

109-11. The nutritional supplement or functional food according to embodiment 102-11 for use in the dietary management of subjects having, being suspected of having or being at risk of developing xanthomata, in particular of a human, even more particular of a human having (pre)hypercholesterolemia

110-11. A method for the dietary management of a subject having, suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, comprising administering to the subject an effective amount of a composition II according to any one of embodiments 1-11 to 73-11 or a nutritional supplement according to any one of embodiments 98-11 to 109-11 or a functional food according to any one of embodiments 98-11 to 109-11.

111-11. The method according to claim 110-11, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing (pre)hypercholesterolemia.

112-11. The method according to claim 110-11, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia. 113-11. The method according to any one of embodiments 110-11 to 112-11, wherein the application rate of the at least one HMO is from 0.1 to 20.0 g/day, preferably from preferably from 1 .0 to 15.0 g/day, more preferably 2.0 to 10.0 g/day, in particular from 2.5 to 5.0 g/day.

114-11. The method according to any one of embodiments 110-11 to 113-11, wherein the application rate of the at least one phytosterol is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1 .5 to 3.0 g per day.

115-11. The method according to any one of embodiments 110-11 to 114-11, wherein the application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g/day, preferably from 1.0 to 9.0 g/day, more preferably from 1.2 to 9.0 g/day, in particular2.0 to 8.0 g/day, especially from 2.5 to 6.0 g/day.

116-11. The method according to any one of embodiments 11-11 to 115-11, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is propionic acid or a derivative thereof and is applied at a rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.

117-11. The method according to any one of embodiments 110-11 to 115-11, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is butyric acid and/or a derivative thereof and is applied at a rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.

118-11. The method according to any one of embodiments 110-11 to 115-11, wherein the at least one

C3-C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day.

119-11. The method according to any one of embodiments 110-11 to 118-11, wherein the nutritional supplement or the functional food is administered orally.

120-11. A composition II according to any one of embodiments 1-11 to 73-11, a composition II for use as a medicament according to embodiment 74-11, a composition II for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-II to 87-II, a nutritional supplement or a functional food according to any one of embodiments 98-II to 109-11, which is administered to a subject having or being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, wherein the composition II according to any one of embodiments 1-11 to 73-11, the composition II for use as a medicament according to embodiment 74-11, the composition II for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-11 to 87-11, the nutritional supplement or a functional food according to any one of embodiments 98-11 to 109-11 is administered to the subject in addition to at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, in particular wherein the application rate of the pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, is reduced compared to a treatment with said pharmaceutical alone. -11. A composition II for use in the treatment or prevention of (pre)hypercholesterolemia according to any one of embodiments 75-11 to 87-11, a nutritional supplement or a functional food according to any one of embodiments 98-11 to 109-11, which is administered to a subject having or being suspected of having or being at risk of developing (pre)hypercholesterolemia, wherein the composition II for use in the treatment or prevention of (pre)hypercholesterolemia according to any one of embodiments 75-11 to 87-11, the nutritional supplement or a functional food according to any one of embodiments 98-11 to 109-11 is administered to the subject in addition to at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia, in particular wherein the application rate of the pharmaceutical suitable to treat said (pre)hypercholesterolemia, is reduced compared to a treatment with said pharmaceutical alone. -11. A composition II for use in the treatment or prevention of morbidities associated to

(pre)hypercholesterolemia according to any one of embodiments 75-11 to 87-11, a nutritional supplement or a functional food according to any one of embodiments 98-11 to 109-11, which is administered to a subject having or being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, wherein the composition II for use in the treatment or prevention of morbidities associated to (pre)hypercholesterolemia according to any one of embodiments 75-11 to 87-11, the nutritional supplement or a functional food according to any one of embodiments 98-11 to 109-11 is administered to the subject in addition to at least one pharmaceutical suitable to treat said morbidities associated to (pre)hypercholesterolemia, in particular wherein the application rate of the pharmaceutical suitable to treat said morbidities associated to (pre)hypercholesterolemia, is reduced compared to a treatment with said pharmaceutical alone.

123-11. A method to treat a subject having (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject a) an effective amount of a composition II according to any one of embodiments 1-11 to 73-11, a composition II for use as a medicament according to embodiment 74-11, a composition II for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-11 to 87-11, a nutritional supplement or a functional food according to any one of embodiments 98-11 to 109-11, or with one, two or three of components A, B and C as described in any one of embodiments 1-11 to 73-11, and b) an effective amount of at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, wherein the application rate of the at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone.

124-11. A method according to embodiment 123-11, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is (pre)hypercholesterolemia and wherein the at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia, is selected from the group of pharmaceuticals of lipid lowering medications (preferably statins, fibrates, nicotinic acid and/or cholestyramine) or immunmodulators (preferably evolocumab, bococizumab and/or alirocumab).

125-1. A composition comprising a) i) at least one HMO, and/or ii) at least one phytosterol, and/or iii) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof; and b) an effective amount of at least one pharmaceutical, especially being suitable for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, in particular for use as a medicament, especially for use in the treatment or prevention of hypercholesterolemia and/or associated morbidities thereto.

126-1. A composition comprising a) i) as component A 2’-FL, and/or ii) as component B sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta- sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and/or iii) as component C propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate; and b) a lipid lowering medications (preferably a statin, fibrate, nicotinic acid and/or cholestyramine) or a immunmodulator (preferably evolocumab, bococizumab and/or alirocumab) in a pharmaceutical effective amount, in particular for use as a medicament, especially for use in the treatment or prevention for hypercholesterolemia and/or associated morbidities thereto.

127-11. Use of the composition II as defined in any one of embodiments 1-11 to 73-11 as a nutritional supplement or as a functional food for the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto.

128-11. A composition II for use as a medicament according to embodiment 74-11, a composition II for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-11 to 87-11, a nutritional supplement or a functional food according to any one of embodiments 98-11 to 109-11, a composition according to any one of embodiments 120-11 to 126-11, wherein the subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years or older.

129-11. A method according to any one of embodiments 88-11 to 97-11 or 110-11 to 119-11 or 123-11 to

124-11, wherein the subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older even more in particular 60 years or older

130-II. A kit for the pharmaceutical use or dietary management use comprising a first component A being at least one HMO, preferably as described in any one of embodiments 1-11 to 73-11, and a second component C being at least one phytosterol B, preferably as described in any of embodiments 1-11 to 73-11, and optionally a third component B being at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, preferably as described in any embodiments 1-11 to 73-11 for the treatment or prevention or dietary management use of (pre)hypercholesterolemia and/or associated morbidities thereto.

131-11. The kit according to embodiment 130-11, wherein the kit is for the pharmaceutical use for the treatment or prevention of (pre)hypercholesterolemia or dietary management use of (pre)hypercholesterolemia.

132-11. The kit according to embodiment 130-11, wherein the kit is for the pharmaceutical use for the treatment or prevention of morbidities associated to (pre)hypercholesterolemia or dietary management use of morbidities associated to (pre)hypercholesterolemia.

It has now been found that C3-C4-alkane carboxylic acids or derivatives thereof can be combined with at least one phytosterol, and optionally with HMOs. Such compositions provide beneficial effects as described herein.

The present invention provides composition III. The composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO.

For the purpose of the present invention, the term “HMO" refers to human milk oligosaccharide(s). These carbohydrates are resistant to enzymatic hydrolysis by digestive enzymes (e.g. pancreatic and/or brush border). In the human breast milk many different kinds of HMOs are found. Each individual HMO is based on a combination of glucose, galactose, sialic acid (N-acetylneuraminic acid), fucose and/or N-acetylglucosamine with many and varied linkages between them. So far over 130 such structures have been identified in human milk. Almost all of them have a lactose moiety at their reducing end while sialic acid and/or fucose (when present) occupy terminal positions at the non-reducing ends. The HMOs can be acidic (e.g. charged sialic acid containing oligosaccharide) or neutral (e.g. fucosylated oligosaccharide).

In an embodiment of the present invention the HMO is selected from the group of fucosylated oligosaccharides, N-acetylated oligosaccharides and sialylated oligosaccharides. In an embodiment of the present invention the HMO is a "fucosylated oligosaccharide". These are HMOs having a fucose residue. It has a neutral nature. Some examples are 2'-FL (2'-fucosyllactose), 3-FL (3-fucosyllactose), difucosyllactose, lacto-N-fucopentaose (e.g. lacto-N- fucopentaose I, lacto- N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V), lacto-N-fucohexaose, lacto-N- difucohexaose I, fucosyllacto-N-hexaose, fucosyllacto- N-neohexaose, difucosyllacto-N-hexaose I, difucosyllacto-N-neohexaose II and any combination thereof. In a preferred embodiment the fucosylated oligosaccharide is selected from the group comprising 2’-FL, 3-FL and difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL). In particular the fucosylated oligosaccharide is 2’-FL.

In another embodiment of the present invention the HMO is a ”N-acetylated oligosaccharide”. The term ”N-acetylated oligosaccharide(s)” encompasses both "N-acetyl-lactosamine" and "oligosaccharide(s) containing N-acetyl-lactosamine". They are neutral oligosaccharides having an N-acetyl-lactosamine residue. Suitable examples are LNT (lacto-N-tetraose), para-lacto-N- neohexaose (para-LNnH), LNnT (lacto-N-neotetraose) or any combination thereof. Other examples are lacto-N-hexaose, lacto-N-neohexaose, para-lacto-N-hexaose, para-lacto-N-neohexaose, lacto- N-octaose, lacto-N- neooctaose, iso- lacto-N-octaose, para- lacto-N-octaose and lacto-N-decaose or any combination thereof. In a preferred embodiment the N-acetylated oligosaccharide is selected from the group of LNT and LNnT.

In another embodiment of the present invention the HMO is a ’’sialylated oligosaccharide". The term ’’sialylated oligosaccharide” encompasses an oligosaccharide having a sialic acid residue. It has an acidic nature. Some examples are 3’-SL (3'-sialyllactose) and 6’-SL (6'-sialyllactose). In a preferred embodiment the sialylated oligosaccharide is 6’-SL.

In another embodiment the HMO is selected from the group comprising 2’-FL, 3-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL and/or any combination thereof. In particular, the HMO is selected from the group comprising 2’-FL, difucosyllactose (e.g. 2’,2”-DiFL and/or 3,2’-DiFL), LNT, LNnT and 6’-SL and/or any combination thereof. Especially the HMO is selected from the group comprising 2’-FL, LNT, LNnT and 6'-SL and/or any combination thereof.

For the purpose of the present invention, the term “C3-C4-alkane carboxylic acid or derivative thereof’ encompasses propionic acid, n-butyric acid and iso-butyric acid (2-methyl propionic acid) as well as derivatives thereof and/or any mixture thereof. Suitable derivatives are salts, esters and amides, in particular physiologically acceptable ones.

Examples for physiologically acceptable salts are alkali salts, like sodium or potassium salts, or alkaline-earth salts, like magnesium or calcium salts, or choline salts. Preferably the physiologically acceptable salts are alkali salts, in particular sodium salts or potassium salts, especially sodium salts.

Examples for physiologically acceptable esters are those derived from C1-C6 alcohols, in particular those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or dihydric C1-C6 alcohols, like those derived from 1 ,2-ethandiol, or C1-C4 alkoxy substituted monohydric alcohols, like those derived from 2-methoxyethanol, 2-ethoxyethanol or 2-butoxyethanol. Other examples for physiologically acceptable esters are glycerides, like mono-, di-, or triglycerides, in particular mono- or diglycerides. Preferably the physiologically acceptable esters are those derived from monohydric C1-C6 alcohols, e.g. those derived from methanol or ethanol, or mono- or diglycerides.

Examples for physiologically acceptable amides are those derived from mono- or di-C1-C6-alkyl amines.

In an embodiment of the present invention the C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid (= free propionic acid) or butyric acid (= free butyric acid) or a mixture thereof.

In another embodiment the C3-C4 alkane carboxylic acid is provided as physiologically acceptable derivative thereof; in particular the derivative is a physiologically acceptable salt, e.g. a sodium salt or potassium salt, or a mixture thereof, or a physiologically acceptable ester, e.g. said ester is derived from C1 -C6 alcohols, in particular a mono-or a dihydric C1 -C6 alcohol, or said ester is a mono- or diglyceride, or a mixture thereof.

In a further embodiment the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate or sodium butyrate or potassium butyrate or a mixture thereof. Especially, it is sodium propionate or sodium butyrate or a mixture thereof.

In a further embodiment the C3-C4-alkane carboxylic acid or derivative thereof is propionic acid or a derivative thereof, in particular it is a physiologically acceptable salt of propionic acid, especially it is sodium propionate or potassium propionate, or a physiologically acceptable ester of propionic acid, especially methyl propionate or ethyl propionate or propionic acid monoglyceride or propionic acid diglyceride, particularly ethyl propionate or propionic acid monoglyceride. In a particular embodiment the C3-C4-alkane carboxylic acid or derivative thereof is sodium propionate or potassium propionate.

In a further embodiment the C3-C4-alkane carboxylic acid or derivative thereof is butyric acid or a derivative thereof, in particular it is a physiologically acceptable salt of butyric acid, especially it is sodium butyrate or potassium butyrate, or a physiologically acceptable ester of butyric acid, especially methyl butyrate or ethyl butyrate or butyric acid monoglyceride or butyric acid diglyceride, particularly ethyl butyrate or butyric acid monoglyceride. In a particular embodiment the C3-C4- alkane carboxylic acid or derivative thereof is sodium butyrate or potassium butyrate.

In a further embodiment the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of propionic acid and butyric acid or derivatives thereof, in particular it is a mixture of physiologically acceptable salts of propionic acid and butyric acid, especially it is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate, or a mixture of physiologically acceptable esters of propionic acid and butyric acid, especially a mixture of methyl propionate and methyl butyrate, or a mixture of ethyl propionate and ethyl butyrate, or a mixture of propionic acid monoglyceride and butyric acid monoglyceride, or a mixture of propionic acid diglyceride and butyric acid diglyceride, particularly a mixture of ethyl propionate and ethyl butyrate or a mixture of propionic acid monoglyceride and butyric acid monoglyceride. In a particular embodiment the at least one C3-C4-alkane carboxylic acid or derivative thereof is a mixture of sodium propionate and sodium butyrate or a mixture of potassium propionate and potassium butyrate.

For the purpose of this invention, the term “phytosterol” relates to at least one plant sterol or plant stand, being present in the free form and/or in the ester form. Examples for plant sterols are sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7- stigmasterol, and the like, and examples for plant stands are sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol, D7-stigmastanol, and the like. In one embodiment they can be present in the form of esters, in particular they are fatty acid esters. Said fatty acids are usually obtained from vegetable oils, like soy bean oil, rape oil and the like. In another embodiment the plant sterol or plant stand can be present in free form. Also, mixtures of the free form and the ester form are possible. Unless otherwise specified in the present application, the terms “phytosterd”, “plant sterol”, “plant stand” as well the individual examples mentioned above relate to the respective free form, or the ester form or mixtures thereof.

In a preferred embodiment the at least one phytosterol is a mixture of two or more phytosterols, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or in another embodiment preferably a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or in another embodiment preferably a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment the at least one phytosterol is derived from vegetable sources, in particular it comprises 40 to 60 weight percent equivalent sitosterol, especially beta-sitosterol, and 10 to 40 weight percent equivalent campesterol. Within this application weight percentage equivalent refer to the weight contribution of the sterol/stanol backbone only, that means that in case the phytosterol is present in ester form the weight contribution of the ester moiety is not counted. The contribution of all sterol/stanol backbones present sums up to 100% weight percent equivalents. In another embodiment the at least one phytosterol derived from vegetable sources comprises 40 to 60 weight percent equivalent sitosterol, especially beta-sitosterol, 10 to 40 weight percent equivalent campesterol and 10 to 30 weight percent equivalent stigmasterol, or it comprises 40 to 60 weight percent equivalent sitosterol, especially beta-sitosterol, 10 to 40 weight percent equivalent campesterol and 0.1 to 3.0 weight percent equivalent stigmasterol.

In another embodiment the at least one phytosterol is derived from wood sources, e.g. from pine, in particular it comprises 45 to 80, especially 65 to 80, weight percent equivalent sitosterol, especially beta-sitosterol, and 3 to 25 weight percent equivalent campesterol. In another embodiment the at least one phytosterol derived from wood sources comprises 45 to 80, especially 65 to 80, weight percent equivalent sitosterol, especially beta-sitosterol, 3 to 25 weight percent equivalent campesterol and 0 to 2 weight percent equivalent stigmasterol, or it comprises 45 to 80, especially 65 to 80, weight percent equivalent sitosterol, especially beta-sitosterol, 3 to 25 weight percent equivalent campesterol and 10 to 20 weight percent equivalent sitostanol, especially beta-sitostanol.

In an embodiment of the present invention the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol.

In another embodiment of the present invention the composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In an embodiment of the present invention the composition III does not comprise one or more HMO.

In another embodiment of the present invention the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO.

In another embodiment of the present invention the composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL.

In an embodiment of the present invention the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO, wherein the ratio of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) and the at least one phytosterol(component C) is from is from 10:1 to 1 : 100, preferably 5:1 to 1 :50, even more preferably 2:1 to 1 :10.

In another embodiment of the present invention the composition III comprises as at least one C3-C4- alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100 : 1 to 1 : 100, preferably from 20:1 to 1 : 20, more preferably from 10:1 to 1 :15, even more preferably from 2: 1 to 1 :8.

In another embodiment of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) and the at least one phytosterol (component C) are present in synergistic amounts.

In an embodiment of the present invention said composition III does not comprise one or more HMO.

In an embodiment of the present invention the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO, wherein the ratio of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) and the at least one phytosterol (component C) is from is from 10:1 to 1 : 100, preferably 5:1 to 1 :50, even more preferably 2:1 to 1 :10, and/or wherein the ratio of the at least one HMO (component A) and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof (component B) is from 100:1 to 1 : 100, preferably from 20:1 to 1 :20, more preferably 10:1 to 1 :10, even more preferably from 3:1 to 1 :3, in particular 2:1 to 1 :2, and/or wherein the ratio of the at least one HMO (component A) and the at least one phytosterol (component C) is from is from 50:1 to 1 : 100, preferably from 25:1 to 1 :50, even more preferably from 20:1 to 1 :30.

In another embodiment of the present invention said composition III comprises as at least one C3- C4-alkane carboxylic acid or derivative(s) thereof a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof, in a ratio of from 100 : 1 to 1 : 100, preferably from 20:1 to 1 : 20, more preferably from 10:1 to 1 :15, even more preferably from 2:1 to 1 :8.

In another embodiment of the present invention the at the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol are present in synergistic amounts.

In another embodiment of the present invention the at least one HMO and the at least one the phytosterol are present in synergistic amounts.

In another embodiment of the present invention the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one HMO are present in synergistic amounts.

In another embodiment of the present invention the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, the at least one phytosterol and the at least one HMO are present in synergistic amounts.

In another embodiment of the present invention the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol, and optionally the at least one HMO is from 1 to 100 wt% of the total composition III, preferably from 10 to 100 wt%.

In another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 95 wt% of the total composition III, preferably from 10 to 90 wt%, more preferably from 15 to 85 wt%, even more preferably from 20 to 75 wt%, in particular from 25 to 60 wt%. In yet another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 50 wt% of the total composition III, preferably from 10 to 45 wt%, more preferably from 15 to 35 wt%. In yet another embodiment the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 95 wt% of the total composition III, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%. In another embodiment the total amount of the at least one phytosterol is from 1 .0 to 95 wt% of the total composition III, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%,. In yet another embodiment the total amount of the at least one phytosterol is from 0.5 to 50 wt% of the total composition III, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%. In yet another embodiment the total amount of the at least one phytosterol is from 50 to 95 wt% of the total composition III, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

In another embodiment the total amount of the at least one HMO is from 0.5 to 95 wt% of the total composition III, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%. In yet another embodiment the total amount of the at least one HMO is from 0.5 to 50 wt% of the total composition III, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%. In yet another embodiment the total amount of the at least one HMO is from 50 to 95 wt% of the total composition III, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

In another embodiment of the present invention the composition III can further comprise one or more vitamins or related compounds thereto. Examples of vitamins and related compounds thereto include vitamin A (e.g. retinol, retinyl acetate, retinyl palmitate, retinyl stearate, retinyl esters with other long-chain unsaturated fatty acids, retinal, retinoic acid and the like), vitamin B1 (e.g. thiamine, thiamine pyrophosphate, TPP, thiamine triphosphate, TTP, thiamine hydrochloride, thiamine mononitrate and the like), vitamin B2 (e.g. riboflavine, flavine mononucleotide (FMN), flavine adenine dinucleotide (FAD), lactoflavine, ovoflavine and the like), vitamin B3 (e.g. nicotinic acid, nicotinamide, nicotinamide adenine dinucleotide (NAD), nicotinic acid mononucleotide (NicMN), pyridine-3-carboxylic acid and the like, as well as the vitamin B3-precursor tryptophan), pantothenic acid (e.g. pantothenate, panthenol and the like), vitamin B6 (e.g. pyridoxine, pyridoxal, pyridoxamine, pyridoxine hydrochloride and the like), biotin, folic acid (e.g. folate, folacin, pteroylglutamic acid and the like), vitamin B12 (e.g. cobalamin, methylcobalamin. deoxyadenosyl- cobalamin, cyanocobalamin, hydroxycobalamin, adenosylcobalamin and the like), vitamin E (e.g. alpha-, beta-, gamma- and/or delta-tocopherol, alpha-, beta-, gamma- and/or delta-tocopherol acetate, alpha-, beta-, gamma- and/or delta-tocopherol succinate, alpha-, beta-, gamma- and/or delta-tocopherol nicotinate, alpha-, beta-, gamma- and/or delta tocotrienol and the like), vitamin K (e.g. vitamin K1 , phylloquinone, naphthoquinone, vitamin K2, menaquinone-7, vitamin K3, menaquinone-4, menadione, menaquinone-7, menaquinone-8, menaquinone-9, menaquinone-10, menaquinone-11 , menaquinone-12, menaquinone-13, and the like ), vitamin C (ascorbic acid), vitamin D (e.g. calciferol, cholecalciferol, 1 ,25-dihydroxyvitamin D, ergocalciferol and the like), and the like and/or mixtures thereof. The presence and amounts of specific vitamins and/or related compounds thereto will vary depending on the intended use.

In a specific embodiment composition III does not comprise one or more HMO.

In a specific embodiment composition III does comprise one or more HMO.

In another embodiment of the present invention the composition III does not comprise one or more vitamins or related compounds thereto.

In another embodiment of the present invention the composition III does comprise one or more vitamins or related compounds thereto.

In another embodiment of the present invention the composition III can further comprise one or more carotenoids. Examples of carotenoids include astaxanthin, alpha-carotene, beta-carotene, beta- cryptoxanthin, lutein, lycopene, meso-zeaxanthin, zeaxanthin and the like (including cis/trans isomers) and/or mixtures thereof. The presence and amounts of specific carotenoids will vary depending on the intended use.

In a specific embodiment composition III does not comprise one or more HMO.

In a specific embodiment composition III does comprise one or more HMO.

In another embodiment of the present invention the composition III does not comprise one or more carotenoids.

In another embodiment of the present invention the composition III can further comprise one or more medium-chain fatty acids. These medium-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or alkyl esters. Examples of medium-chain fatty acids include caproic acid, caprylic acid, capric acid, lauric acid and the like and /or mixtures thereof.

The presence and amounts of specific medium chain fatty acids will vary depending on the intended use.

In a specific embodiment composition III does not comprise one or more HMO.

In a specific embodiment composition III does comprise one or more HMO. In another embodiment of the present invention the composition III does not comprise one or more medium-chain fatty acids.

In another embodiment of the present invention the composition III can further comprise one or more long-chain fatty acids. These long-chain fatty acids may be provided as free fatty acids, as glycerides (e.g. as monoglycerides, diglycerides or triglycerides and/or as mixtures thereof), as phospholipids, as alkyl esters and/or as mixtures thereof, preferably as glycerides, more preferably as triglycerides or as alkyl esters. Examples of long chain fatty acids include saturated long chain fatty acids (e.g. myristic acid, palmitic acid, stearic acid, arachidic acid, behenic acid, lignoceric acid, cerotic acid and the like and/or mixtures thereof), mono-unsaturated long chain fatty acids (e.g. myristoleic acid, palmitoleic acid, sapienic acid, oleic acid, elaidic acid, vaccenic acid, erucic acid and the like and/or mixtures thereof), polyunsaturated long chain fatty acids (e.g. linoleic acid, linoelaidic acid, alpha-linolenic acid, arachidonic acid, eicosapentaenoic acid, docosapentenoic acid, docosahexaenoic acid and the like and/or mixtures thereof) and/or mixtures thereof. These long chain fatty acids are comprised for example in vegetable oils, single cell oils and marine oils, e.g. fish oil, krill oil and the like.

The presence and amounts of specific long chain fatty acids will vary depending on the intended use.

In a specific embodiment composition III does not comprise one or more HMO.

In a specific embodiment composition III does comprise one or more HMO.

In another embodiment of the present invention the composition III does not comprise one or more long-chain fatty acids.

In another embodiment of the present invention the composition III can further comprise one or more prebiotics. Examples of prebiotics include water-insoluble fibers (e.g. lignin, cellulose, hemi- cellulose, resistant starch, xanthum gum and the like and/or mixtures thereof), water-soluble fibers (e.g. arabinoxylan, inulin, pectin, alginic acid and derivatives thereof, agar, carrageen, raffinose, xylose, polydextrose, lactulose, and the like and/or mixtures thereof), other oligosaccharides like xylooligosaccharides, fructooligosaccharides, galactooligosaccharides, isomalto-oligosaccharides and the like and/or mixtures thereof.

The presence and amounts of specific prebiotics will vary depending on the intended use.

In a specific embodiment composition III does not comprise one or more HMO. In a specific embodiment composition III does comprise one or more HMO.

In another embodiment of the present invention the composition III does not comprise one or more prebiotics.

In another embodiment of the present invention the composition III can further comprise one or more probiotics. Examples of probiotics optionally present in the composition III of the present invention include microorganisms or parts thereof of the family Lactobacillaceae, e.g. of the genus Lactobacillus (e.g. the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii (like lactobacillus delbrueckii spp. bulgaricus, lactobacillus delbrueckii spp. delbrueckii, lactobacillus delbrueckii spp. lactis), lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus rhamnosus, lactobacillus salivarius and the like), of the genus Bifidobacterium (e.g. the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum and the like), of the genus Pediococcus (e.g. the species pediococcus acidilactici, pediococcus pentosaceus and the like), of the genus Lactococcus (e.g. the species lactococcus lactis (like lactococcus latis spp. cremoris, lactococcus lactis spp. lactic and the like) and of the genus Streptococcus (e.g. the species streptococcus thermophilus and the like) and of the genus Faecalibacterium (e.g. the species faecalibacterium prausnitzii) and of the genus Bacillus (e.g. the species bacillus subtilis) and the like and/or mixtures thereof.

The presence and amounts of specific probiotics will vary depending on the intended use.

In a specific embodiment composition III does not comprise one or more HMO.

In a specific embodiment composition III does comprise one or more HMO.

In another embodiment of the present invention the composition III does not comprise one or more probiotics.

In another embodiment of the present invention the composition III can further comprise one or more phenolic compounds. Examples of phenolic compounds include monophenols (e.g. apiole, carnosol, carvacrol, dillapiole, rosemarinol and the like), flavonoids (e.g. quercetin, kaempferol, myricetin, fisetin, rutin, isorhamnetin, hesperidin, naringenin, silybin, eriodyctiol, acacetin, apigenin, chrysin, diosmetin, tangeritin, luteolin, catechins like epigallocatechin gallate, theaflavin, thearubigins, proanthocyanidins, pelargonidin, peonidin, cyanidin, delphinidin, malvidin, petunidin and the like), isoflavonoids (e.g. daidzein, genistein, glycitein and the like), aurones, chalconoids, flavonolignans, lignans, phytoestrogens, stilbenoids (e.g. resveratrol, pterostilbene, piceatannol and the like), curcuminoids (e.g. curcumin and the like), tannins, aromatic acids (e.g. salicylic acid, vanillic acid, gallic acid, ellagic acid, tannic acid, caffeic acid, chlorogenic acid, cinnamic acid, ferulic acid, coumarin and the like), phenylethanoids (e.g. tyrosol, hydroxytyrosol, oleocanthal, oleuropein and the like ), capsaicin, gingerol, alkylresorcinol and the like and/or mixtures thereof.

The presence and amounts of specific phenolic compounds will vary depending on the intended use.

In a specific embodiment composition III does not comprise one or more HMO.

In a specific embodiment composition III does comprise one or more HMO.

In another embodiment of the present invention the composition III does not comprise one or more phenolic compounds.

In another embodiment of the present invention the composition III can further comprise one or more herbals, e.g. known from Chinese diets, Indian diets, Mediterranean diets and the like. These herbals can be provided as powders obtained from the plant and/or fungus or parts thereof or as extracts thereof.

Examples for herbals known from Chinese diets include extracts or powders of hawthorn fruit, wolfberry, spatholobus stem, caterpillar fungus, cloud mushroom, crysanthemum, honeysuckle flower, mulberry leaf, glossy privet fruit, malaytea scurfpea fruit, cherokee rose fruit, palmleaf raspberry fruit, Chinese magnoliavine fruit, reishi mushroom, ephedra, epimedium, Angelica root, Astragalus root, rhubarb, licorice, morinda root, notoginseng, white peony root, American ginseng, fleeceflower root, kudzu root, rehmannia root, salvia root, Chinese yam, wild buckwheat rhizome, tall gastrodia tuber, golden root, Cassia seed, Coix seed, Dodder seed and the like and/or mixtures thereof.

Examples for herbals known from Indian diets include extracts or powders of Amalaki (Indian gooseberry), Haritaki (chebulic myrobalan), Bibhitaki (beleric), Haldi (turmeric), Tulsi (holy basil), Shigru (moringa), Twak (cinnamon), Yashtimadhu (licorice root), Dhanyaka (coriander), Ashwagandha (winter cherry), Kumkuma (saffron), Manjistha (Indian madder), Brahmi (bacopa), Neem (margosa), Ajwain (Bishop’s weed), Elaichi (cardamom), Shikakai (Acacia concinna), Shatavari (wild asparagus), Jeera (cumin), Guduchi (tinospora) and the like and/or mixtures thereof. Examples for herbals known from Mediterranean diets include extracts or powders of rosemary, basil, parsley, saffron, thyme, oregano, sage, cilantro, lemon, orange, grape, grapeseed, fig, blueberry, raspberry, strawberry, cherry, fennel, sesame seeds, pine seeds, garlic, onion, ginger root, pepper, chili and the like, olive oil and/or mixtures thereof.

The presence and amounts of specific herbals will vary depending on the intended use.

In a specific embodiment composition III does not comprise one or more HMO. In a specific embodiment composition III does comprise one or more HMO.

In another embodiment of the present invention the composition III does not comprise one or more herbals.

In another embodiment of the present invention the composition III can further comprise one or more minerals. Examples of minerals include such ones comprising calcium, phosphorous, iodine, iron, magnesium, copper, zinc, manganese, chlorine, potassium, sodium, selenium, chromium, molybdenum and the like and/or mixtures thereof. In a further embodiment of the present invention the composition III does not comprise a mineral comprising iron. Minerals are usually added in salt form.

The presence and amounts of specific minerals will vary depending on the intended use.

In a specific embodiment composition III does not comprise one or more HMO.

In a specific embodiment composition III does comprise one or more HMO.

In another embodiment of the present invention the composition III does not comprise one or more minerals.

In another embodiment of the present invention the composition III does not comprise one or more antibodies.

The compositions III of the present invention can be prepared by mixing the at least one phytosterol, and the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally the at least one HMO, and optionally further components e.g. vitamins and related compounds thereto, carotenoids, medium chain fatty acids, long chain fatty acids, prebiotics, probiotics, phenolic compounds, herbals, minerals and the like and/or mixtures thereof, as known in the art. In an embodiment thereof the composition III does not comprise more than 80 wt% water.

Furthermore, the present invention provides a composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, ii) at least one phytosterol, and optionally iii) at least one HMO, for use as a medicament, preferably as a medicament for mammals and/or birds, in particular as a medicament for mammals. For the purpose of the present invention, the term ’’mammals” encompasses humans and non human mammals. Examples for non-human mammals are livestock, e.g. sheep, goats, pigs, cattles, horses, camels, llamas and the like, and pets, e.g. cats, dogs and the like.

In a preferred embodiment of the present invention the composition III is for use as a medicament for humans.

In another preferred embodiment of the present invention the composition III is for use as a medicament for livestock and/or pets.

In another preferred embodiment of the present invention the composition III is for use as a medicament for birds, crustaceans, e.g. poultry (like chickens, ducks, geese, turkeys and the like) and ornamental birds (like canaries and the like).

The compositions III of the present invention for use as a medicament can be administered orally, enterally or parenterally, preferably orally.

In an embodiment of the present invention the composition III for use as a medicament is an orally administrable composition.

In another embodiment of the present invention the composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and optionally iii) as component A 2’-FL, for use as a medicament, preferably as a medicament for humans.

It is understood that the embodiments mentioned for the composition III shall be applicable for the compositions III for use as a medicament and the specific embodiments thereto.

Furthermore, the present invention provides a composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO, for the use in the treatment and/or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, preferably of mammals, more preferably of humans.

For the purpose of the present invention the term ’’treatment” in the context of (pre)hypercholesterolemia and/or associated morbidities thereto means using an effective therapy or management to alleviate, reduce or cure the condition and/or disease ((pre)hypercholesterolemia and/or associated morbidities thereto) and/or symptoms thereof, as the case may be, in addition it also includes the stabilization of the condition and/or disease, as the case may be, in order not to worsen in the course of the respective condition and/or disease. In an embodiment of the present invention treatment is understood as using an effective therapy or management to stabilize, alleviate or reduce the condition and/or disease and/or symptoms thereof, as the case may be.

Within the context of the present invention the term ’’prevention” in the context of (pre)hypercholesterolemia and/or associated morbidities thereto means an effective therapy or management so that the condition and/or disease ((pre)hypercholesterolemia and/or associated morbidities thereto) does not de novo develop, manifest and/or symptoms thereof do not occur.

In an embodiment of the present invention the composition III is for use in the treatment of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention the composition III is for use in the prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

For the purpose of the present invention the term ’’(pre)hypercholesterolemia” refers to a condition and/or disease, as the case may be, which is characterized by an abnormal and/or excessive increase of the level of total cholesterol in blood of a respective subject. In particular, a subject with a level of total cholesterol in blood of 200 mg/ml_ or more is considered (pre)hypercholesterolemic.

Within the context of the present invention the term “pre-hypercholesterolemia“ refers to a condition or disease wherein the respective subject shows a level of total cholesterol in the blood of 200 to 239 mg/dL and the term “hypercholesterolemia” refers to a condition or disease wherein the respective subject shows a level of total cholesterol in the blood of 240 mg/dL or more. .

In an embodiment of the present invention the composition III is for use in the treatment or prevention of pre-hypercholesterolemia of a human. In an embodiment of the present invention the composition III is for use in the treatment or prevention of hypercholesterolemia of a human.

For the purpose of the present invention the term “associated morbidities” as well as the term ’’morbidities associated to” mean one or more conditions and/or diseases which are co-occurring to the primary condition or disease ((pre)hypercholesterolemia), or which are occurring later in the life of the subject who had earlier in his or her life said primary condition and/or disease ((pre)hypercholesterolemia).

In another embodiment of the present invention the composition III is for use in the treatment or prevention of an associated morbidity, e.g. an associated morbidity of the cardiovascular system, which includes atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure, deep vein thrombosis etc., an associated morbidity of the abdomen, which includes transient ischemic attack (which manifests as abdominal pain), intestinal embolism, renal failure etc., an associated morbidity of the brain and/or nerves, which includes transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure, stroke etc., an associated morbidity of the lungs, which includes transient ischemic attack (which manifests as chest pain), pulmonary embolism, respiratory failure etc., an associated morbidity of the eyes, which arcus senilis, transient ischemic attack (which manifests as visual loss, eye embolism, visual failure etc., an associated morbidity of the skin, which xanthelasma palpebarum etc., an associated morbidity of the tendons, which xanthomata etc., and the like, in particular of a human.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of an associated morbidity of the cardiovascular system, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of an associated morbidity of the abdomen, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia. In another embodiment of the present invention the composition III is for use in the treatment or prevention of transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of an associated morbidity of the brain and nerves, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of an associated morbidity of the lungs, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of an associated morbidity of the eyes, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism, visual failure, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of an associated morbidity of the skin, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia. In another embodiment of the present invention the composition III is for use in the treatment or prevention of xanthelasma palpebarum, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of an associated morbidity of the tendons, in particular of a human subject having prehypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III is for use in the treatment or prevention of xanthomata, in particular of a human subject having pre-hypercholesterolemia or in particular of a human subject having hypercholesterolemia.

In another embodiment of the present invention the composition III for use in the treatment or prevention of (pre)hypercholesterolemia is an orally, enterally or parenterally, preferably orally administrable composition, in particular for a human subject.

In another embodiment of the present invention the composition III for use in the treatment or prevention of morbidities associated to (pre)hypercholesterolemia is an orally, enterally or parenterally, preferably orally administrable composition, in particular for a human subject.

In an embodiment of the present invention the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of a mammal, especially of pre-hypercholesterolemia of a human or especially of hypercholesterolemia of a human or especially of morbidities associated to (pre)hypercholesterolemia of a human.

In another embodiment of the present invention the composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto of a mammal, in particular of pre-hypercholesterolemia of a human, or in particular of hypercholesterolemia of a human or in particular of morbidities associated to (pre)hypercholesterolemia of a human.

In an embodiment of the present invention the composition III for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, in particular of a mammal, especially of pre-hypercholesterolemia of a human or especially of hypercholesterolemia of a human or especially of morbidities associated to (pre)hypercholesterolemia of a human, does not comprise one or more HMO.

In another embodiment of the present invention the composition III comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO, and for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto of a mammal, in particular of pre-hypercholesterolemia of a human, or in particular of hypercholesterolemia of a human or in particular of morbidities associated to (pre)hypercholesterolemia of a human.

In another embodiment of the present invention the composition III comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL, for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto of a mammal, in particular of pre-hypercholesterolemia of a human, or in particular of hypercholesterolemia of a human or in particular of morbidities associated to (pre)hypercholesterolemia of a human.

It is understood that the embodiments mentioned for the composition III shall be applicable for the compositions III for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto and the specific embodiments thereto. Furthermore, the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO.

In an embodiment of the invention said method is for treating a subject having prehypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention said method is for treating a subject having hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention said method is for treating a subject having morbidities associated to (pre)hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to (pre)hyper- cholesterolemia, in particular a human.

In another embodiment of the invention said human subject is in the age of 12 years or older, preferably 18 years or older, more preferably 35 years or older, in particular 50 years or older, even more particular 60 years or older.

It is understood that in this method the composition III can be administered, preferably orally, or that any of the “at least one phytosterol ” and the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and optional the “at least one HMO” and optional further components can be administered separately, preferably orally. Furthermore it is understood that in case composition III comprises as the at least one phytosterol two or more phytosterols these can be administered separately, preferably orally, and in case composition III comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally, and in case composition III comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally. In another embodiment thereof, the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g.

In another embodiment thereof, the propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day.

In a further embodiment thereof, the butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1 .0 to 5.0 g/day.

In another embodiment the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g, preferably the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g, more preferably the daily application rate of propionic acid and/or a derivative thereof is from 1.0 to 3.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 1 .5 to 4.0 g.

In another embodiment the daily application rate of the at least one phytosterol is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1.5 to 3.0 g.

In an embodiment thereof, the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and ii) at least one phytosterol, and

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition III which comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of said composition III which does not comprise one or more HMO.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO.

In another embodiment the present invention provides a method to treat a subject having a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, or to prevent a subject being suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the composition III which comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL. It is understood that the embodiments mentioned for the composition III shall be applicable for the use of the composition III in this method accordingly and in the specific embodiments thereto.

Furthermore, the present invention provides the use of a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment the present invention provides the use of a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III, which does not comprise one or more HMO, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL, for the manufacture of a medicament, preferably for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the invention the medicament manufactured as mentioned above is for treating a subject having pre-hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention the medicament manufactured as mentioned above is for treating a subject having hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention the medicament manufactured as mentioned above is for treating a subject having morbidities associated to (pre)hypercholesterolemia, in particular a human, or preventing a subject being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, in particular a human.

It is understood that the embodiments mentioned for the composition III shall be applicable for the use of the composition III in this use accordingly and in the specific embodiments thereto.

Furthermore, the present invention provides a nutritional supplement comprising a composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO. For the purpose of the present invention the term “nutritional supplement” means a manufactured product intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of (pre)hypercholesterolemia and/or associated morbidities thereto. Examples for nutritional supplements include “dietary supplements” and “medical foods”. A dietary supplement is intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, however it needs not to be used under medical supervision. A medical food is also intended to supplement a diet, in particular of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, but it is under medical supervision. The terms “medical foods” and “food for special medical purpose” are interchangeable.

It is understood that the nutritional supplement can comprise said composition III or that the nutritional supplement can comprise any of the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and “at least one phytosterol” and optional the “at least one HMO” and optional further components in separate form.

In an embodiment of the present invention the nutritional supplement is a dietary supplement.

In another embodiment of the present invention the nutritional supplement is a medical food.

In an embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In another embodiment thereof, the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1 .2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g. Preferably, propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day. Preferably butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day. In another embodiment the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g, preferably the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g, more preferably the daily application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 1 .5 to 4.0 g.

In another embodiment the daily application rate of the at least one phytosterol is from is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1 .5 to 3.0 g.

In an embodiment thereof, the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.

In another embodiment of the invention said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years or older.

It is understood that in this method the nutritional supplement can be administered, preferably orally, or that any of the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and the “at least one phytosterol” and the optional at least one HMO” and optional further components can be administered separately, preferably orally. Furthermore it is understood that in case the nutritional supplement comprises as at least one HMO two or more HMOs that these can be administered separately, preferably orally, and in case the nutritional supplement comprises as at least one C3- C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof that these can be administered separately, preferably orally, and in case the nutritional supplement comprises as at least one phytosterol two or more phytosterols that these can be administered separately, preferably orally.

Furthermore, the present invention provides a nutritional supplement comprising a composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a nutritional supplement comprising a composition III which comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In another embodiment the present invention provides a nutritional supplement comprising a composition III which does not comprise one or more HMO, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a nutritional supplement comprising a composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO, and in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In another embodiment the present invention provides a nutritional supplement comprising a composition III which comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said nutritional supplement is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia. It is understood that the embodiments mentioned for the composition III as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the nutritional supplement accordingly and as well as to the specific embodiments thereto.

Furthermore, the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol and optionally iii) at least one HMO.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the nutritional supplement can comprise said composition III or that the nutritional supplement can comprise any of the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and “at least one phytosterol” and optional the “at least one HMO” and optional further components in separate form. Furthermore, it is understood that in case composition III comprises as the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3- C4-alkane carboxylic acid or derivative(s) thereof these can be administered separately, preferably orally, and in case composition III comprises as the at least one phytosterol two or more phytosterols these can be administered separately, preferably orally, and in case composition III comprises as the at least one HMO two or more HMOs these can be administered separately, preferably orally.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment the present invention said method supplement is for the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition III, which does not comprise one or more HMO.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol and iii) at least one HMO. In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the nutritional supplement which comprises a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition III as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the use of the nutritional supplement in this method accordingly as well as in the specific embodiments thereto.

Furthermore, the present invention provides the use of a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment the present invention provides the use of a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III, which does not comprise one or more HMO, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL, for the manufacture of a nutritional supplement, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having pre-hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having or being suspected of having or being at risk of developing a morbidity associated to (pre)hypercholesterolemia, in particular a human.

It is understood that the embodiments mentioned for the composition III shall be applicable for the use of the composition III in this use accordingly and in the specific embodiments thereto.

Both, the medicament (in general and for the respective specific use) and the nutritional supplement (in general and for the respective specific use) of the present invention can be delivered in any suitable format. Formulations suitable for oral administration may be in the form of capsules, tablets, pills, dragees, lozenges (using a flavored basis, usually sucrose and acacia ortragacanth), powders, granules, and the like or as a solution or a suspension in an aqueous or non-aqueous liquid, or as an oil-in-water or water-in-oil liquid emulsion, or as an elixir or syrup, or as pastilles (using an inert base, such as gelatin and glycerin, or sucrose and acacia), each comprising a predetermined amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, the at least one phytosterol, optional the at least one HMO and optional further components. The medicament (in general and for the respective specific use) and/or the nutritional supplement (in general and for the respective specific use) of the present invention may also be administered as a bolus, electuary or paste.

It is understood that the active ingredients of said medicament and nutritional supplement can be delivered together in a respective suitable format or that each of component B and component C and optionally component A can be delivered in a respective format or that each of the active ingredients can be delivered in a respective format, or any combination thereof. In solid dosage forms for oral administration (capsules, tablets, pills, dragees, lozenges, powders, granules, and the like), the desired components of the composition III may be mixed with one or more pharmaceutically acceptable carriers, such as sodium citrate or dicalcium phosphate, and/or any of the following: (1) fillers or extenders, such as starches, lactose, sucrose, glucose, mannitol, and/or silicic acid; (2) binders, such as carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone, sucrose and/or acacia; (3) humectants, such as glycerol; (4) disintegrating agents, such as agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate; (5) solution retarding agents, such as paraffin; (6) absorption accelerators, such as quaternary ammonium compounds; (7) wetting agents, such as acetyl alcohol and glycerol monostearate; (8) absorbents, such as kaolin and bentonite clay; (9) lubricants, such a talc, calcium stearate, magnesium stearate, solid polyethylene glycols, sodium lauryl sulfate, and mixtures thereof; (10) coloring agents; and (11) flavors, such as lemon, orange, apricot, banana, cherry, strawberry, raspberry, blueberry, peppermint, vanilla, chocolate, coffee, cappuccino flavor and the like. In some cases, the compositions III may also comprise buffering agents.

In a specific embodiment, powders and/or granules can be reconstituted with water or another aqueous liquid prior to consumption. In a particular embodiment the so obtained liquid does not comprise more than 80 wt% water.

In another embodiment such above-mentioned liquid formulations do not comprise more than 80 wt% water.

Furthermore, the present invention provides a functional food comprising a composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO.

For the purpose of the present invention the term “functional food” means a food which is fortified with the composition III according to the present invention and intended to be used in a diet, in particular of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto. The terms “functional food” and “fortified food” are interchangeable.

Examples for foods being suitable for the preparation of functional foods are (1) dairy products e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) bakery products e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) candy products e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) beverage products e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.

It is understood that the functional food can comprise said composition III or that the functional food can comprise any of the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and “at least one phytosterol” and optional the “at least one HMO” and optional further components in separate form.

Furthermore it is understood that in case the composition III comprises as the at least one C3- C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof these can be comprised separately in the functional food or together as composition, and in case the composition III comprises as the at least one phytosterol two or more phytosterols these can be comprised separately in the functional food or together, and in case the composition III comprises as the at least one HMO two or more HMOs these can be comprised separately in the functional food or together as composition.

In an embodiment of the present invention the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing pre hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the present invention the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the present invention the functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In another embodiment thereof, the daily application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is 0.1 to 10.0 g, preferably from 1.0 to 9.0 g, more preferably from 1.2 to 9.0 g, in particular from 2.0 to 8.0 g, especially from 2.5 to 6.0 g. Preferably, propionic acid and/or a derivative thereof can be administered in an application rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1 .0 to 4.0 g/day. Preferably butyric acid and/or a derivative thereof can be administered in an application rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day. In another embodiment the daily application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g, preferably the daily application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g, more preferably the daily application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g, and the daily application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g.

In another embodiment the daily application rate of the at least one phytosterol is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1.5 to 3.0 g.

In an embodiment thereof, the daily application rate of the at least one HMO is from 0.1 to 20.0 g, preferably from 1.0 to 15.0 g, more preferably from 2.0 to 10.0 g, in particular from 2.5 to 5.0 g.

In another embodiment of the invention said subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years and older.

In an embodiment the present invention provides a functional food comprising a composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a functional food comprising a composition III which comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides a functional food comprising a composition III which does not comprise one or more HMO, in particular for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto. In another embodiment the present invention provides a functional food comprising a composition III which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO.

In another embodiment the present invention provides a functional food comprising a composition III which comprises i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL.

In another embodiment of the present invention said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing prehypercholesterolemia.

In another embodiment of the present invention said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said functional food is for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition III as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the functional food accordingly as well as to the specific embodiments thereto.

Furthermore, the present invention provides a method for the dietary management of a subject having, being suspected to have or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In an embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the “at least one C3-C4-alkane carboxylic acid or derivative(s) thereof’ and the “at least one phytosterol” and optional the “at least one HMO” and optional further components can be comprised separately in the functional food or together as composition. Furthermore it is understood that in case the composition III comprises as at least one C3-C4-alkane carboxylic acid or derivative(s) thereof two or more C3-C4-alkane carboxylic acid or derivative(s) thereof that these can be comprised separately in the functional food or together as composition, and in case the composition III comprises as at least one phytosterol two or more phytosterols that these can be comprised separately in the functional food or together as composition, and in case the comprises as at least one HMO two or more HMOs that these can be comprised separately in the functional food or together as composition.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of a functional food which comprises a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

In another embodiment of the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

In an embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition III, which does not comprise one or more HMO.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO.

In another embodiment the present invention provides a method for the dietary management of a subject having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject an effective amount of the functional food which comprises a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing pre-hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing hypercholesterolemia.

In another embodiment of the present invention said method is for the dietary management of a subject having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

It is understood that the embodiments mentioned for the composition III as well as those mentioned for (pre)hypercholesterolemia and morbidities associated to (pre)hypercholesterolemia shall be applicable for the use of the functional food in this method accordingly as well as in the specific embodiments thereto.

Furthermore, the present invention provides the use of a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment the present invention provides the use of a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III, which does not comprise one or more HMO, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III comprising i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and ii) at least one phytosterol, and iii) at least one HMO, for the manufacture of afunctional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides the use of a composition III comprising i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and iii) as component A 2’-FL, for the manufacture of a functional food, preferably for the dietary management of subjects having, being at risk or developing (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment of the invention the functional food manufactured as mentioned above is for the dietary management of a subject having pre-hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing pre-hypercholesterolemia, in particular a human.

In an embodiment of the invention the functional food manufactured as mentioned above is for the dietary management of a subject having hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing hypercholesterolemia, in particular a human.

In another embodiment of the invention the nutritional supplement manufactured as mentioned above is for the dietary management of a subject having morbidities associated to (pre)hypercholesterolemia, in particular a human, or a subject being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, in particular a human.

It is understood that the embodiments mentioned for the composition III shall be applicable for the use of the composition III in this use accordingly and in the specific embodiments thereto.

The functional food of the present invention can be prepared by known techniques and it can have any suitable type of format such as (1) a dairy product e.g. yogurt, dessert, smoothie, milk and the like or mixtures thereof; (2) a bakery product e.g. bread, rolls, pasta, cookie, cake, cereal bar and the like or mixtures thereof; (3) a candy product e.g. candies, gummies, chewing gum, chocolate, pudding, cookie and the like or mixtures thereof; (4) a beverage product e.g. fruit juice, vegetable juice, lemonade, water and the like or mixtures thereof.

Furthermore, it is contemplated herein that the composition III, the composition III for use as a medicament, the composition III for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, the nutritional supplement and the functional food, in particular for use in the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto, respectively, as disclosed herein, can be co-administered to subjects receiving at least one pharmaceutical against said (pre)hypercholesterolemia and/or associated morbidities thereto. Examples for pharmaceuticals used in the treatment of (pre)hypercholesterolemia are

- lipid-lowering medications (statins, fibrates, nicotinic acid, cholestyramine and the like)

- immunomodulators (evolocumab, bococizumab, alirocumab and the like).

Furthermore, the present invention provides a method to treat a subject having (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject a) an effective amount of a composition III, a composition III for use as a medicament, a composition III for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, a nutritional supplement or a functional food, in particular for use in the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto, which comprises i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and optionally ii) at least one phytosterol, and optionally iii) at least one HMO; and b) an effective amount of at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, in particular, wherein the application rate of the at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone.

In an embodiment thereof the (pre)hypercholesterolemia and/or associated morbidities thereto is (pre)hypercholesterolemia and the pharmaceutical is

- lipid-lowering medications (statins, fibrates, nicotinic acid, cholestyramine and the like)

- immunomodulators (evolocumab, bococizumab, alirocumab and the like).

Furthermore, the present invention provides a composition comprising a) i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and/or ii) at least one phytosterol and/or iii) at least one HMO; and b) an effective amount of at least one pharmaceutical, in particular for use as a medicament, especially for use in the treatment of (pre)hyper- cholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and/or ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and/or iii) as component A 2’-FL; and b) a lipid-lowering medications (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like), in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) as component B at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, preferably propionic acid and/or butyric acid or derivative(s) thereof, more preferably sodium propionate and/or sodium butyrate, and b) a lipid-lowering medications (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like), in a pharmaceutical effective amount, without any phytosterol, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) as component C at least one phytosterol, preferablysitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably the component C is a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and b) a lipid-lowering medications (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like), in a pharmaceutical effective amount, without any C3-C4-alkane carboxylic acid or derivative(s) thereof, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

In an embodiment thereof the present invention provides a composition comprising a) as component A at least one HMO, preferably 2’-FL, and b) a lipid-lowering medications (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like), in a pharmaceutical effective amount, without any C3-C4-alkane carboxylic acid or derivative(s) thereof and/or without any phytosterol, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

It is understood that the embodiments mentioned for the components and for the diseases and the symptoms mentioned above shall apply here to.

In particular, the composition III, the composition III for use as a medicament, the composition III for use in the treatment or prevention of (pre)hypercholesterolemia, the nutritional supplement or the functional food, in particular for use in the dietary management of (pre)hypercholesterolemia, used in said method comprises propionic acid and/or butyric acid or derivative(s) thereof, and/or at least one of sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol, and/or

- 2’-FL, preferably sodium propionate and sodium butyrate, sitosterol, in particular beta-sitosterol, and/or campesterol, and/or optionally 2’-FL.

In another embodiment the composition III, the composition III for use as a medicament, the composition III for use in the treatment or prevention of a morbidity associated to (pre)hypercholesterolemia, the nutritional supplement or the functional food, in particular for use in the dietary management of a morbidity associated to (pre)hypercholesterolemia, used in said method comprises propionic acid and/or butyric acid or derivative(s) thereof, and/or at least one of sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol, and/or

- 2’-FL, preferably sodium propionate and sodium butyrate, sitosterol, in particular beta-sitosterol, and/or campesterol, and/or optionally 2’-FL.

In an embodiment of the present invention the nutritional supplement or the functional food is for use in the dietary management of pre-hypercholesterolemia.

In an embodiment of the present invention the nutritional supplement or the functional food is for use in the dietary management of hypercholesterolemia. In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of a morbidity associated to (pre)hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the cardiovascular system, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the abdomen, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia .

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia .

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of brain and/or nerves, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke,, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the lungs, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the eyes, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism, visual failure, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the skin, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of xanthelasma palpebarum, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of an associated morbidity of the tendons, in particular of a human subject having or being suspected of having or at risk of developing prehypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

In another embodiment of the present invention the nutritional supplement or the functional food is for use in the in the dietary management of xanthomata, in particular of a human subject having or being suspected of having or at risk of developing pre-hypercholesterolemia, or in particular of a human subject having or being suspected of having or at risk of developing hypercholesterolemia.

Furthermore, the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and comprising a second component comprising at least one phytosterol and optionally a third component comprising at least one HMO.

In an embodiment the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate and a second component comprising sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5- avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta- sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol and optionally a third component comprising 2’-FL.

In another embodiment the present invention provides a kit for the pharmaceutical use or dietary management use comprising a first component comprising propionic acid or derivative(s) thereof, preferably sodium propionate, and a second component comprising butyric acid or derivative(s) thereof, preferably sodium butyrate, and a third component comprising sitosterol, in particular beta- sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and optionally a forth component comprising 2’-FL.

In another embodiment the present invention provides said kit for the pharmaceutical use for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto or for the dietary management use of the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto.

In another embodiment the present invention provides said kit for the pharmaceutical use for the treatment or prevention of pre-hypercholesterolemia or for the dietary management use of the dietary management of pre-hypercholesterolemia.

In another embodiment the present invention provides said kit for the pharmaceutical use or dietary management use for the treatment or prevention of hypercholesterolemia or dietary management use for the dietary management of hypercholesterolemia.

In another embodiment the present invention provides said kit for the pharmaceutical use for the treatment or prevention of morbidities associated to (pre)hypercholesterolemia or for the dietary management use of the dietary management of associated morbidities to (pre)hypercholesterolemia.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and optionally a third component comprising at least one phytosterol.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, and optionally a third component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta- sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol. Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one phytosterol, and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and optionally a third component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta- sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, and optionally a third component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one HMO and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and optionally a third component comprising at least one C3- C4-alkane carboxylic acid or derivative(s) thereof and/or at least one phytosterol.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is 2’-FL, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, and optionally a third component is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, and/or optionally a third component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

Furthermore, the present invention provides a kit for the pharmaceutical use comprising a first component comprising at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and a second component comprising a pharmaceutical, preferably a pharmaceutical for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, and a third component comprising at least one phytosterol and a forth component comprising at least one HMO.

In an embodiment the present invention provides a kit for the pharmaceutical use comprising a first component which is propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and sodium butyrate, a second component comprising a lipid-lowering medication (like a statin, fibrate, nicotinic acid, cholestyramine and the like) or a immunomodulator (like evolocumab, bococizumab, alirocumab and the like) in a pharmaceutical effective amount, a third component which is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5- avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta- sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and a forth component which is 2’-FL.

It is understood that the embodiments mentioned for the components A, B and C as well as for the diseases shall be applicable for the kit accordingly and in the specific embodiments thereto.

It is understood that the embodiments mentioned for the components A, B and C shall be applicable for the kit accordingly and in the specific embodiments thereto.

Within the context of the present invention, the term "butyric acid" denotes n-butyric acid and the term “butyrate” denotes n-butyrate. Also within the content of the present invention, the term ”at least one HMO” is interchangeable with the term ’’component A”, and the term ”at least one C3-C4-alkane carboxylic acid or a derivative thereof’ is interchangeable with the term “component B”, and the term “at least one phytosterol” is interchangeable with the term “component C”.

Wthin the context of the present application, it is noted that in case a composition comprises several components that these can also be administered separately. However, this means that such components can be administered together or separately, as the case may be.

Also, within the context of the present invention, ratios given are weight to weight ratios unless stated otherwise. The weight unit “meg” stands for micro gram. In addition, in the context of the invention, the terms "comprising" or "comprises" do not exclude other possible elements. The composition of the present invention, including the embodiments described herein, can comprise, consist of, or consist essentially of the essential elements and limitations of the invention described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise depending on the needs. The terminology as set forth herein is for description of the embodiments only and should not be construed as limiting the disclosure as a whole. In a particular embodiment the compositions of the invention consist essentially of the essential elements, and even more particular consist of the essential elements. Furthermore, as used in the description and the appended claims, the singular forms "a", "an", and "the" are inclusive of their plural forms, and the other way around, unless the context clearly indicates otherwise. It is to be understood that the embodiments of the subject matter of the invention can be applied in the specific context but also in other combinations, without leaving the scope of the invention. E.g. it is understood that the embodiments mentioned for the composition of the present invention also apply for composition for use as a medicament, etc. The same applies for the respective conditions and/or diseases.

In the following specific embodiments III of the present invention are described.

1-111. A composition III comprising i) at least one C3-C4-alkane carboxylic acid or a derivative thereof, and ii) at least one phytosterol, and optionally iii) at least one HMO.

2-MI. The composition III according to embodiments 1-111, wherein one of the at least one C3-C4- alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof.

3-MI. The composition III according to any one of embodiments 1-111 to 2-MI, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of propionic acid.

4-MI. The composition III according to any one of embodiments 1-111 to 3-MI, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of propionic acid.

5-MI. The composition III according to any one of embodiments 1-111 to 4-MI, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium salt of propionic acid.

6-III. The composition III according to any one of embodiments 1-111 to 5-111 wherein the at least one C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate. 7-III. The composition III according to any one of embodiments 1-111 to 3-111, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid.

8-MI. The composition III according to any one of embodiments 1-111 to 7-MI, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is butyric acid or a derivative thereof.

9-MI. The composition III according to any one of embodiments 1-111 to 8-MI, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt or ester of butyric acid.

10-111. The composition III according to any one of embodiments 1-111 to 9-MI, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of butyric acid.

11-MI. The composition III according to any one of embodiments 1-111 to 10-111, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium salt of butyric acid.

12-111. The composition III according to any one of embodiments 1-111 to 11-111 wherein the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium butyrate.

13-111. The composition III according to any one of embodiments 1-111 to 9-MI, wherein one of the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of butyric acid.

14-111. The composition III according to any one of embodiments 1-111 to 13-111, wherein the at least one C3-C4-alkane carboxylic acid or a derivative thereof is propionic acid or a derivative thereof and butyric acid or a derivative thereof.

15-111. The composition III according to any one of embodiments 1-111 to 14-111, wherein the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable salt of propionic acid and physiologically acceptable salt of butyric acid.

16-111. The composition III according to any one of embodiments 1-111 to 15-111, wherein the at least one C3-C4-alkane carboxylic acid or a derivative thereof is an alkali salt or an alkaline earth salt of propionic acid and an alkali salt or an alkaline earth salt of butyric acid. 17-111. The composition III according to any one of embodiments 1-111 to 16-111, wherein the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a sodium or potassium salt of propionic acid and a sodium or potassium salt of butyric acid.

18-111. The composition III according to any one of embodiments 1-111 to 17-111 wherein the at least one C3-C4-alkane carboxylic acid or a derivative thereof is sodium or potassium propionate and sodium or potassium butyrate.

19-111. The composition III according to any one of embodiments 1-111 to 14-111, wherein the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a physiologically acceptable ester of propionic acid and a physiologically acceptable ester of butyric acid.

20-111. The composition III according to any one of embodiments 1-111 to 19-111, wherein the at least one C3-C4-alkane carboxylic acid or a derivative thereof is a C1-C6 alkyl ester or a mono- or diglyceride of propionic acid and a C1 -C6 alkyl ester or a mono- or diglyceride of butyric acid.

21-111. The composition III according to any one of embodiments 1-111 to 20-111, wherein the at least one phytosterol is at least one of plant sterols or plant stanols, wherein said plant sterols and/or said plant stanols are present in free form and/or in ester form.

22-111. The composition III according to embodiment 1-111 to 21-111, wherein the plant sterol and the plant stanol is sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta-sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol.

23-111. The composition III according to any one of embodiments 1-111 to 22-111, wherein the plant sterol and the plant stanol is a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol.

24-111. The composition III according to any one of embodiments 1-111 to 23-111, wherein the plant sterol and the plant stanol is a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol.

25-111. The composition III according to any one of embodiments 1-111 to 24-111 which does not comprise one or more HMOs. 26-III. The composition III according to any one of embodiments 1-111 to 24-111 which comprise at least one HMO.

27-111. The composition III according to any one of embodiment 1-111 to 24-111, wherein one of the at least one HMO’s is a fucosylated oligosaccharide.

28-111. The composition III according to embodiment 1-111 or 27-111, wherein one of the at least one

HMO is 2’-fucosyllactose (2’-FL).

29-111. The composition III according to any one of embodiments 1-111 to 28-111, wherein one of the at least one HMO’s is a sialylated oligosaccharide.

30-111. The composition III according to any one of embodiments embodiment 1-111 to 29-111, wherein one of the at least one HMO is 6’-sialyllactose (6’-SL).

31-111. The composition III according to any one of embodiments 1-111 to 30-111, wherein one of the at least one HMO’s is a N-acetylated oligosaccharide.

32-111. composition III according to any one of embodiments 1-111 to 31-111, wherein one of the at least one HMO is lacto-N-tetraose (LNT).

33-111. The composition III according to any one of embodiments 1-111 to 32-111, wherein the at least one HMO is one or more HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyl- lactose (in particular 2’, 2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL.

34-111. The composition III according to any one of embodiments 1-111 to 33-111, wherein the at least one HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 3-FL, difucosyllactose (in particular 2’, 2”-DiFL and/or 3, 2’-DiFL), LNT, LNnT, 3’-SL and 6’-SL.

35-1. The composition III according to any one of embodiments 1-111 to 34-111, wherein the at least one HMO is one, two or three HMOs selected from the group consisting of 2’-FL, LNT, LNnT, 3’-SL and 6’-SL.

36-111. The composition III according to any one of embodiments 1-111 to 34-111, wherein the at least one HMO is one, two or three HMOs selected from the group consisting of 2’-FL, 2’,2”-DiFL and 3,2’-DiFL. -III. The composition III according to any one of embodiments 1-111 to 36-111 wherein the at least one HMO is 2’-FL. -111. The composition III according to any one of embodiments 1-111 to 37-111, wherein the weight to weight ratio of the at least one C3-C4 alkane carboxylic acid or a derivative thereof (component B) : the at least one phytosterol (component C) is from 10:1 to 1 : 100, preferably 5:1 to 1 :50, even more preferably 2:1 to 1 :10. -MI. The composition III according to any one of embodiments 14-111 to 38-111, wherein the weight to weight ratio of the propionic acid or a derivative thereof : butyric acid or a derivative thereof is from 100:1 to 1 : 100. -MI. The composition III according to any one of embodiments 14-111 to 39-111, wherein the weight to weight ratio of the propionic acid or a derivative thereof : butyric acid or a derivative thereof is from 20:1 to 1 :20, preferably from 10:1 to 1 :15, more preferably from 2:1 to 1 :8. -111. The composition III according to any one of embodiments 1-111 to 40-111, wherein the weight to weight ratio of the at least one HMO (component A) : (component C) is from is from 50:1 to 1 :100, preferably from 25:1 to 1 :50, more preferably from 20.1 to 1 :30. -MI. The composition III according to any one of embodiments 1-111 to 41-111, wherein the weight to weight ratio of (component A) : (component B) is from 100:1 to 1 :100. -MI. The composition III according to any one of embodiments 1-111 to 42-111, wherein the weight to weight ratio of (component A) : (component B) is from 20:1 to 1 :20, preferably from 10:1 to 1 :10, more preferably from 3:1 to 1 :3, in particular from 2:1 to 1 :2. -MI. The composition III according to any one of embodiments 1-111 to 43-111, wherein the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol are present in synergistic amounts. -111. The composition III according to any one of embodiments 1-111 to 44-111, wherein the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one HMO are present in synergistic amounts. -111. The composition III according to any one of embodiments 1-111 to 45-111, wherein the at least one HMO and the at least one phytosterol are present in synergistic amounts. 47-III. The composition III according to any one of embodiments 1-111 to 46-111, wherein the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol and the at least one HMO are present in synergistic amounts.

48-111. The composition III according to any one of embodiments 1-111 to 47-111, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof and the at least one phytosterol and optionally the at least one HMO is from 1 to 100 wt% of the total composition III, preferably from 10 to 100 wt%.

49-ill. The composition III according to any one of embodiments 1-111 to 48-111, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from0.5 to 95 wt% of the total composition III, preferably from 10 to 90 wt%, more preferably from 15 to 85 wt%, even more preferably from 20 to 75 wt%, in particular from 25 to 60 wt%.

50-ill. The composition III according to any one of embodiments 1-111 to 49-111, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.5 to 50 wt% of the total composition III, preferably from 10 to 45 wt%, more preferably from 15 to 35 wt%.

51-111. The composition III according to any one of embodiments 1-111 to 49-111, wherein the total amount of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 50 to 90 wt% of the total composition III, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

52-111. The composition III according to any one of embodiments 1-111 to 51-111, wherein the total amount of the at least one phytosterol is from 1.0 to 95 wt% of the total composition III, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt%, or wherein the total amount of the at least one phytosterol is from 0.5 to 50 wt% of the total composition III, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%, or wherein the total amount of the at least one phytosterol is from 50 to 95 wt% of the total composition III, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

53-ill. The composition III according to any one of embodiments 1-111 to 52-111, wherein the total amount of the at least one HMO is from 0.5 to 95 wt% of the total composition III, preferably from 10 to 90 wt%, more preferably from 20 to 80 wt%, even more preferably from 30 to 70 wt%, in particular from 40 to 60 wt. 54-III. The composition III according to any one of embodiments 1-111 to 52-111, wherein the total amount of the at least one HMO is from 0.5 to 50 wt% of the total composition III, preferably from 5 to 40 wt%, more preferably from 8 to 35 wt%, even more preferably from 10 to 30 wt%

55-ill. The composition III according to any one of embodiments 1-111 to 52-111, wherein the total amount of the at least one HMO is from 50 to 95 wt% of the total composition III, preferably from 55 to 80 wt%, more preferably from 60 to 75 wt%.

56-111 The composition III according to any one of embodiments 1-111 to 55-111, wherein the composition III further comprises one or more vitamins or related compounds thereto.

57-111. A composition III according to embodiment 56-111, wherein the one or more vitamins or related compounds thereto are selected from the group of vitamin A, vitamin B1 , vitamin B2, vitamin B3, pantothenic acid, vitamin B6, biotin, folic acid, vitamin B12, vitamin E, vitamin K, vitamin C and vitamin D, or related compounds thereto and/or mixtures thereof.

58-MI. The composition III according to embodiment 57-I, wherein the composition III further comprises one or more carotenoids.

59-MI. The composition III according to embodiment 58-MI, wherein one or more carotenoids are selected from the group of astaxanthin, alpha-carotene, beta-carotene, beta-cryptoxanthin, lutein, lycopene, meso-zeaxanthin, zeaxanthin and the like (including cis/trans isomers) and/or mixtures thereof..

60-MI. The composition III according to any one of embodiments 1-111 to 59-111, wherein the composition III further comprises one or more medium-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof.

61-111. The composition III according to embodiment 60-111, wherein the one or more medium chain fatty acids are selected from the group of caproic acid, caprylic acid, capric acid, lauric acid and/or mixtures.

62-111. The composition III according to any one of embodiments 1-111 to 61-111, wherein the composition III further comprises one or more long-chain fatty acids, in free form, as glyceride, phospholipid, alkyl ester and/or mixtures thereof. 63-III. The composition III according to embodiment 62-ill, wherein the one or more long chain fatty acids are selected from the group of saturated long chain fatty acids, mono-unsaturated long chain fatty acids, polyunsaturated long chain fatty acids and/or mixtures thereof.

64-MI. The composition III according to any one of embodiments 1-111 to 63-111, wherein the composition III further comprises one or more prebiotics.

65-111. The composition III according to embodiment 64-111, wherein the one or more prebiotics are selected from the group of water-insoluble fibers, water-soluble fibers, or oligosaccharides, preferably xylooligosaccharides, fructooligosaccharides, galactooligosaccharides and/or isomalto-oligosaccharides, and/or mixtures thereof.

66-111. The composition III according to any one of embodiments 1-111 to 65-111, wherein the composition III further comprises one or more probiotics.

67-111. The composition III according to embodiment 66-111, wherein the one or more probiotics are selected from the group of the family Lactobacilaceae, preferably of the genus Lactobacillus, in particular of the species lactobacillus acidophilus, lactobacillus alimentarius, lactobacillus casei, lactobacillus delbrueckii, lactobacillus helveticus, lactobacillus plantarum, lactobacillus reuteri, lactobacillus rhamnosus, lactobacillus salivarius, of the genus Bifidobacterium, in particular of the species bifidobacterium animalis, bifidobacterium bifidum, bifidobacterium breve, bifidobacterium infantis, bifidobacterium lactis, bifidobacterium longum, of the genus Pediococcus, in particualar of the species pediococcus acidilactici, pediococcus pentosaceus, of the genus Lactococcus, in particular of the species lactococcus lactis, of the genus Streptococcus, in particular of the species streptococcus thermophilus, of the genus Faecalibacterium, in particular of the species faecalibacterium prausnitzii, of the genus Bacillus, in particular of the species bacillus subtilis, and/or mixtures thereof.

68-111. The composition III according to any one of embodiments 1-111 to 67-111, wherein the composition III further comprises one or more phenolic compounds.

69-111. The composition III according to embodiment 68-111, wherein the one or more phenolic compounds are selected from the group of monophenols, flavonoids, isoflavonoids, aurones, chalconoids, flavonolignans, lignans, phytoestrogens, stilbenoids, piceatannol, curcuminoids, tannins, aromatic acids, phenylethanoids, capsaicin, gingerol, alkylresorcinol and/or mixtures thereof. -III. The composition III according to any one of embodiments 1-111 to 69-111, wherein the composition III further comprises one or more herbals. -111. The composition III according to embodiment 70-111, wherein the one or more herbals are selected from herbals known from Chinese diets, Indian diets, Mediterranean diets and/or mixtures thereof. -111. The composition III according to any one of embodiments 1-111 to 71-111, wherein the composition III further comprises one or more minerals. -111. The composition III according to any one of embodiments 1-111 to 72-111, wherein the composition does not comprise an antibody. -111. A composition III as described in any one of the embodiments 1-111 to 73-111 for use as a medicament, preferably as a medicament for mammals and/or birds, more preferably for mammals, even more preferably for humans. -111. A composition III as described in any one of embodiments 1-111 to 73-111 for use in the treatment and/or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans. -111. The composition III according to embodiment 75-111, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is pre-hypercholesterolemia, in particular of a human. -111. The composition III according to embodiment 75-111, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is a hypercholesterolemia, in particular of a human. -111. The composition III according to embodiment 75-111, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is an associated morbidity, in particular of a human. -111. A composition III as described in any one of embodiments 1-111 to 78-111, wherein the associated morbidity is an associated morbidity of the cardiovascular system, an associated morbidity of the abdomen, an associated morbidity of the brain and/or nerves, an associated morbidity of the lungs, an associated morbidity of the eyes, an associated morbidity of the skin, or an associated morbidity of the tendons, in particular a human, even more particular a human having (pre)hypercholesterolemia. -III. A composition III as described in any one of embodiments 1-111 to 79-111, wherein the associated morbidity is atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -111. A composition III as described in any one of embodiments 1-111 to 79-111, wherein the associated morbidity is transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -111. A composition III as described in any one of embodiments 1-111 to 79-111, wherein the associated morbidity is transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -111. A composition III as described in any one of embodiments 1-111 to 79-111, wherein the associated morbidity is transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -II.A composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -11. A composition II as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is xanthelasma palpebarum of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -11. A composition III as described in any one of embodiments 1-11 to 79-11, wherein the associated morbidity is xanthomata of a subject, in particular a human, even more particular a human having (pre)hypercholesterolemia. -111. The composition III according to any one of embodiments 74-111 to 86-111, wherein the composition III is an orally administrable composition. -III. A method for treating a subject having, suspected of having or being at risk of developing a disease, in particular (pre)hypercholesterolemia and/or associated morbidities thereto comprising administering to the subject an effective amount of a composition III according to any one of embodiments 1-111 to 73-111. -111. The method according to embodiment 88-111, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing (pre)hypercholesterolemia. -111. The method according to embodiment 88-111, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia. -111. The method according to any one of embodiments 88-111 to 90-111, wherein the application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g/day, preferably from 1.0 to 9.0 g/day, more preferably from 1.2 to 9.0 g/day, in particular from 2.0 to 8.0 g/day, especially from 2.5 to 6.0 g/day. -MI. The method according to any one of embodiments 88-MI to 91-111, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is propionic acid or a derivative thereof and is applied at a rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1.0 to 4.0 g/day. -MI. The method according to any one of embodiments 88-MI to 92-MI, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is butyric acid and/or a derivative thereof and is applied at a rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day. -MI. The method according to any one of embodiments 88-MI to 93-MI, wherein the at least one C3-

C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day. 95-III. The method according to any one of embodiments 88-MI to 94-MI, wherein the application rate of at least one phytosterol is from 0.5 to 10.0 g, preferably from 1 .0 to 5.0 g, in particular from 1.5 to 3.0 g per day.

96-MI. The method according to any one of embodiments 88-MI to 95-MI, wherein the application rate of the at least one HMO is from 0.1 to 20.0 g/day, preferably from 1.0 to 15.0 g/day, more preferably from 2.0 to 10.0 g/day, in particular from 2.5 to 5.0 g/day.

97-ill. The method according to any one of embodiments 88-ill to 96-ill, wherein the composition III is administered orally.

98-ill. A nutritional supplement or a functional food comprising a composition III according to any one of embodiments 1-111 to 73-111.

99-111. The nutritional supplement or the functional food according to embodiment 98-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans.

100-111. The nutritional supplement or functional food according to embodiment 98-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing (pre)hypercholesterolemia, in particular pre-hypercholesterolemia or in particular hypercholesterolemia, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans.

101-111. The nutritional supplement or functional food according to embodiment 99-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, preferably of mammals and/or birds, more preferably of mammals, even more preferably of humans.

102-111. The nutritional supplement or functional food according to embodiment 101-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing an associated morbidity of the cardiovascular system, an associated morbidity of the abdomen, an associated morbidity of the brain and/or nerves, an associated morbidity of the eyes, an associated morbidity of the skin or an associated morbidity of the tendons, in particular of a human, even more particular of a human having (pre)hypercholesterolemia. -111. The nutritional supplement or functional food according to embodiment 102-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing atherosclerosis, transient ischemic attack (which manifests as chest pain and/or leg pain), cardiovascular disease, coronary embolism, myocardial infarction, congestive heart failure and/or deep vein thrombosis, in particular of a human, even more particular of a human having (pre)hypercholesterolemia. -111. The nutritional supplement or functional food according to embodiment 102-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing transient ischemic attack (which manifests as abdominal pain), intestinal embolism and/or renal failure, in particular of a human, even more particular of a human having (pre)hypercholesterolemia. -111. The nutritional supplement or functional food according to embodiment 102-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing transient ischemic attack (which manifests as dizziness, impairment of balance, difficulties in speaking, weakness, numbness and/or tingling), brain embolism, cognitive failure, neuro-muscular failure and/or stroke, in particular of a human, even more particular of a human having (pre)hypercholesterolemia. -111. The nutritional supplement or functional food according to embodiment 102-111 for use in the dietary management of subjects having, being suspected of having or being at risk of transient ischemic attack (which manifests as chest pain), pulmonary embolism and/or respiratory failure, in particular of a human, even more particular of a human (pre)hypercholesterolemia. -11. The nutritional supplement or functional food according to embodiment 102-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing arcus senilis, transient ischemic attack (which manifests as visual loss), eye embolism and/or visual failure, in particular of a human, even more particular of a human having (pre)hypercholesterolemia. -11. The nutritional supplement or functional food according to embodiment 102-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing xanthelasma palpebarum, in particular of a human, even more particular of a human having (pre)hypercholesterolemia. -11. The nutritional supplement or functional food according to embodiment 102-111 for use in the dietary management of subjects having, being suspected of having or being at risk of developing xanthomata, in particular of a human, even more particular of a human having (pre)hypercholesterolemia

110-111. A method for the dietary management of a subject having, suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto, comprising administering to the subject an effective amount of a composition III according to any one of embodiments 1-111 to 73-111 or a nutritional supplement according to any one of embodiments 87-111 to 109-111 or a functional food according to any one of embodiments 98-111 to 109-111.

111-111. The method according to claim 110-111, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing (pre)hypercholesterolemia.

112-111. The method according to claim 110-111, wherein the subject, in particular a human, has, is suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia.

113-111. The method according to any one of embodiments 110-111 to 112-111, wherein the application rate of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is from 0.1 to 10.0 g/day, preferably from 1 .0 to 9.0 g/day, more preferably from 1.2 to 9.0 g/day, in particular from 2.0 to 8.0 g/day, especially from 2.5 to 6.0 g/day.

114-111. The method according to any one of embodiments 110-111 to 113-111, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is propionic acid or a derivative thereof and is applied at a rate from 0.1 to 6.0 g/day, preferably from 0.5 to 5.0 g/day, more preferably from 1.0 to 4.0 g/day.

115-111. The method according to any one of embodiments 110-111 to 114-111, wherein one of the at least one C3-C4-alkane carboxylic acid or derivative(s) thereof is butyric acid and/or a derivative thereof and is applied at a rate from 0.1 to 9.0 g/day, preferably from 0.5 to 7.0 g/day, more preferably from 1.0 to 5.0 g/day.

116-111. The method according to any one of embodiments 110-111 to 115-111, wherein the at least one

C3-C4-alkane carboxylic acid or derivative(s) thereof is a mixture of propionic acid or a derivative thereof and butyric acid or a derivative thereof and the application rate of propionic acid and/or a derivative thereof is from 0.1 to 4.0 g/day and the application rate of butyric acid and/or a derivative thereof is from 0.1 to 6.0 g/day, preferably the application rate of propionic acid and/or a derivative thereof is from 0.5 to 4.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 0.5 to 5.0 g/day, more preferably the application rate of propionic acid and/or a derivative thereof is from 1 .0 to 3.0 g/day, and the application rate of butyric acid and/or a derivative thereof is from 1.5 to 4.0 g/day.

117-111. The method according to any one of embodiments 110-111 to 116-111, wherein the application rate of the at least one phytosterols is from 0.5 to 10.0 g, preferably from 1.0 to 5.0 g, in particular from 1 .5 to 3.0 g per day.

118-111. The method according to any one of embodiments 110-111 to 117-111, wherein the application rate of the at least one HMO is from 0.1 to 20.0 g/day, preferably from 1.0 to 15.0 g/day, more preferably from 2.0 to 10.0 g/day, in particular from 2.5 to 5.0 g/day.

119-111. The method according to any one of embodiments 110-111 to 118-111, wherein the nutritional supplement or the functional food is administered orally.

120-111. A composition III according to any one of embodiments 1-111 to 73-111, a composition III for use as a medicament according to embodiment 74-111, a composition III for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-111 to 87-111, a nutritional supplement or a functional food according to any one of embodiments 98-111 to 109-111, which is administered to a subject having or being suspected of having or being at risk of developing (pre)hypercholesterolemia and/or associated morbidities thereto , wherein the composition III according to any one of embodiments 1-111 to 73-111, the composition III for use as a medicament according to embodiment 74-111, the composition III for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-111 to 87-111, the nutritional supplement or a functional food according to any one of embodiments 98-111 to 109-111 is administered to the subject in addition to at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, in particular wherein the application rate of the pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, is reduced compared to a treatment with said pharmaceutical alone.

121-111. A composition III for use in the treatment or prevention of (pre)hypercholesterolemia according to any one of embodiments 75-111 to 87-111, a nutritional supplement or a functional food according to any one of embodiments 98-111 to 109-111, which is administered to a subject having or being suspected of having or being at risk of developing (pre)hypercholesterolemia, wherein the composition III for use in the treatment or prevention of (pre)hypercholesterolemia according to any one of embodiments 75-111 to 87-111, the nutritional supplement or a functional food according to any one of embodiments 98-III to 109-111 is administered to the subject in addition to at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia, in particular wherein the application rate of the pharmaceutical suitable to treat said (pre)hypercholesterolemia, is reduced compared to a treatment with said pharmaceutical alone. -111. A composition III for use in the treatment or prevention of morbidities associated to

(pre)hypercholesterolemia according to any one of embodiments 75-111 to 87-111, a nutritional supplement or a functional food according to any one of embodiments 98-111 to 109-111, which is administered to a subject having or being suspected of having or being at risk of developing morbidities associated to (pre)hypercholesterolemia, wherein the composition III for use in the treatment or prevention of morbidities associated to (pre)hypercholesterolemia according to any one of embodiments 75-111 to 87-111, the nutritional supplement or a functional food according to any one of embodiments 98-111 to 109-111 is administered to the subject in addition to at least one pharmaceutical suitable to treat said morbidities associated to (pre)hypercholesterolemia, in particular wherein the application rate of the pharmaceutical suitable to treat said morbidities associated to (pre)hypercholesterolemia, is reduced compared to a treatment with said pharmaceutical alone. -111. A method to treat a subject having (pre)hypercholesterolemia and/or associated morbidities thereto, by administering to the subject a) an effective amount of a composition III according to any one of embodiments 1-111 to 73- IN, a composition III for use as a medicament according to embodiment 74-111, a composition III for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-111 to 87-111, a nutritional supplement or a functional food according to any one of embodiments 98-111 to 109-NI, or with one, two or three of components A, B and Cas described in any one of embodiments 1-NI to 73-NI, and b) an effective amount of at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto, wherein the application rate of the at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia and/or associated morbidities thereto is reduced compared to a treatment with the at least one pharmaceutical alone. -111. A method according to embodiment 123-111, wherein the (pre)hypercholesterolemia and/or associated morbidities thereto is (pre)hypercholesterolemia and wherein the at least one pharmaceutical suitable to treat said (pre)hypercholesterolemia, is selected from the group of pharmaceuticals of lipid lowering medications (preferably statins, fibrates, nicotinic acid and/or cholestyramine) or immunmodulators (preferably evolocumab, bococizumab and/or alirocumab).

125-111. A composition comprising a) i) at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, and/or ii) at least one phytosterol, and/or iii) at least one HMO; and b) an effective amount of at least one pharmaceutical, especially being suitable for the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto, in particular for use as a medicament, especially for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto.

126-111. A composition comprising a) i) as component B propionic acid and/or butyric acid or derivative(s) thereof, preferably sodium propionate and/or sodium butyrate, and/or ii) as component C sitosterol, in particular beta-sitosterol, campesterol, stigmasterol, brassicasterol, D5-avenasterol, D7-stigmasterol, sitostanol, in particular beta- sitostanol, campestanol, stigmastanol, brassicastanol, D5-avenastanol or mixtures thereof, preferably a mixture comprising sitosterol, especially beta-sitosterol, and campesterol, or a mixture comprising sitosterol, especially beta-sitosterol, and stigmasterol, or a mixture comprising sitosterol, especially beta-sitosterol, and sitostanol, especially beta-sitostanol, and/or iii) as component A 2’-FL; and b) a lipid lowering medications (preferably a statin, fibrate, nicotinic acid and/or cholestyramine) or a immunmodulator (preferably evolocumab, bococizumab and/or alirocumab) in a pharmaceutical effective amount, in particular for use as a medicament, especially for use in the treatment or prevention for (pre)hypercholesterolemia and/or associated morbidities thereto.

127-111. Use of the composition III as defined in any one of embodiments 1-111 to 73-111 as a nutritional supplement or as a functional food for the dietary management of (pre)hypercholesterolemia and/or associated morbidities thereto. 128-111. A composition III for use as a medicament according to embodiment 74-111, a composition III for use in the treatment or prevention of (pre)hypercholesterolemia and/or associated morbidities thereto according to any one of embodiments 75-111 to 87-111, a nutritional supplement or a functional food according to any one of embodiments 98-1 to 109-1, a composition according to any one of embodiments 120-111 to 126-111, wherein the subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older, even more in particular 60 years or older.

129-111. A method according to any one of embodiments 88-111 to 97-111 or 110-111 to 119-111 or 123-111 to 124-111, wherein the subject is a human, preferably in the age of 12 years or older, more preferably 18 years or older, even more preferably 35 years or older, in particular 50 years or older even more in particular 60 years or older.

130-III. A kit for the pharmaceutical use or dietary management use comprising a first component B being at least one C3-C4-alkane carboxylic acid or derivative(s) thereof, preferably as described in any of embodiments 1-111 to 73-111, and a second component C being at least one phytosterol, preferably as described in any embodiments 1-111 to 73-111, and optionally a third component A being at least one HMO, preferably as described in any one of embodiments 1-111 to 73-111, for the treatment or prevention or dietary management use of (pre)hypercholesterolemia and/or associated morbidities thereto.

131-111. The kit according to embodiment 130-111, wherein the kit is for the pharmaceutical use for the treatment or prevention of (pre)hypercholesterolemia or dietary management use of (pre)hypercholesterolemia.

132-111. The kit according to embodiment 130-111, wherein the kit is for the pharmaceutical use for the treatment or prevention of morbidities associated to (pre)hypercholesterolemia or dietary management use of morbidities associated to (pre)hypercholesterolemia.

Examples

The following examples illustrate certain exemplary embodiments of the subject matter of the present invention as detailed above. The Examples are given solely for the purpose of illustration and are not to be construed as limitation. Example 1 : Randomized, double blind study

The study was performed with seventy-two patients in a double-blind, randomized clinical trial.

Patients meet the below criteria to be included in the trial: between 18 and 90 years of age, primary Parkinson syndrome, moderate disease severity (UPDRS III 8 or lower, stable daily dosage of 500 - 850 mg per day levodopa), completely oriented regarding time, place and person, independent mobility without, with one-sided or two-sided walking aid. and did not meet any of the following exclusion criteria: bad general condition, pregnancy, serious accompanying illness or organ dysfunction (e. g. Heart Faillure NYHA grade lll-IV, severe respiratory failure (e.g. with calm dyspnea), irreversible multiple organ failure, sepsis, acute viral hepatitis, serious disease of the gastrointestinal tract, malignancies (actual or in actual follow-up, aftercare), therapy with immunesuppresiva in the last 6 months (e.g. with mitoxantron, azathioprin, cyclophosphamid), vegan eating habits.

The patients were grouped in three groups, in one group each of the patients received 1260 mg per day sodium propionate and 2550 mg per day sodium butyrate, in another group each of the patients received 3250 mg per day 2’-FL, and in the third group each of the patients received 1260 mg per day sodium propionate, 2550 mg per day sodium butyrate and 3250 mg per day 2’-FL, for the duration of the trial. During the trial the individual dosage of each of the patients with levodopa was readjusted if possible and/or necessary.

At the beginning of the trial, after 12 weeks and after 24 weeks the blood pressure and the dosage of levodopa of each patient was determined. It could be observed that the total cholesterol levels of the blood of the patients did improve.