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Translation ¾rcuie I .OJ

PatXML 1/23 Lp11646

Description

FUNCTIONAL FOOD PREPARATION AND USE THEREOF

[0001] the present invention concerns a food preparation comprising botanical

products which contain various active principles suitable for preventing

and treating disorders, In particular hypercholesterolemia and

cardlo-clrculatory disorders.

[0002] The main feature of the functional food preparation of the invention is that

it combines a specific phytoestrogen, that is soy isoflavone, with specific

active principles, that is polycosanols and coenzymes, in a single widely

used food preparation belonging to the category of dairy products and/or

soy based preparations and/or rice based preparations.

[0003] Isoflavones are chemical compounds present In nature belonging to the

category of botanical phenols comprised In the class of flavonoids.

Isoflavones can be found In Leguminoseae and Iridaceae and In particular

the can be found In Papilionideae, which are of the family of

Leguminoseae, so that they can be found In foods such as chickpeas,

grains, beans, fennels, lentils, soybeans.

[0004] Several clinical studies (Zhuo XG et al. 2004; G. Moscow, 2008; S. Zhan

et al, 2005) have highlighted the effects of soy protein and of the

isoflavones contained in them on cholesterol and triglycerides and and

they have shown that soy protein containing Isoflavones exerted a

significant action to reduce total cholesterol, LDL cholesterol (low density

lipoprotein) and triglycerides, with an action of Increasing HDL cholesterol

(high density lipoprotein - good cholesterol). The reducing effect has been

shown to be as greater as higher was the cholesterol level before

treatment.

[0005] Isoflavones, in structural and functional terms, are similar to estrogens

produced by the body, with the property of binding to the same receptors.

For this reason they are commonly called phytoestrogens, including one of

the most important and studied which is the genistein and the respective

b-glucoside genistein. In the soy-based foods they can be found in the

form glucoslnoiate, although the bio-active form Is the glucose free

Isoflavone, which is the aglycone. Therefore, natural soy isoflavones must

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be activated, through the hydrolysis of the glucosidic group, to acquire

their biological function.

[0006] In the gastrointestinal apparatus are present enzymes called

beta-glucosldase Involved in the separation of glucose so transforming the

molecule of glucose into the active form named aglycone, and in this form

it can be absorbed in the intestine.

The aglycone is structurally similar to estrogen and can bind to the same

receptors. In humans, there are two different receptors for estrogen and

called ERb (A. Bitto, 2010). With regards to such receptors there is a

different and very Interesting receptor binding activity made by

phytoestrogens, especially genistein, because genistein has a high affinity

for ERb estrogen-like, 20 times greater than the affinity for the receptor

ERa. This differentiated action of genistein leads to a different profile of

safety and efficacy; effectiveness can be explained by referring to the high

affinity of genistein for the estrogen receptor type b (ERb) which is

abundant In the cardiovascular system.

[0007] This publication also showed that the daily intake of genistein aglycone

resulted In a statistically significant reduction of both the decrease in

plasma cholesterol and in the number and intensity of hot flushes, with

absence of side effects, but the interest on isoflavones, further to receiving

scientific confirmations on Its cholesterol-lowering action, has gone far

beyond even coming to confirm the protective action on bone and

cardiovascular system.

[0008] Several studies (MJ Tlkkanen & Adlercreutz, H., 2010, M. Valente, 2009)

have emphasized that the beneficial effect on the cardiovascular are

achieved through the modification of the lipid phenotype with reduction in

LDL, triglycerides and platelet aggregation, the increase in HDL,

apolipoprotein A and coronary vascular reactivity in general.

[0009] Genistein also has proven effective In reducing the growth of blood

vessels that feed tumors. This seems to explain the protective effect that

soy, according to some studies, have against the development of prostate

cancer in humans.

[0010] In patent EP 0998206 is claimed a food preparation In the form of a

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powder mixture, containing isoflavones Including soy flour, ground flax

seeds which contain more phytoestrogens such as llgnans, and

fructooligosaccharides, Inulin in particular, while in patent applications

W097/32593 and GB 1219584 describe mixtures of food components

including even these phytoestrogens - isoflavones and llgnans - for the

production of biscuits with beneficial health effects as supplements of flour

in bread production.

[0011] Differently, the inventor has realized as particularly synergistic and

effective in the prevention and treatment of various disease states

including those noted above, the association of isoflavones with specific

active principles, other than phytoestrogens, such as active policosanol,

coenzymes, plant statins, cynarin and others as described below.

[0012] Main object of the present Invention is Indeed to propose a food

preparation that contains botanical substances that combine and optimize

a cholesterol stabilizing action with a protective action of the

cardio-vascular.

[0013] Further object of the present Invention is to propose a food preparation

including plant substances that, in addition to optimized properties for

stabilizing cholesterol and for cardiovascular protection, they also have an

antioxidant, anti-tumor and liver protection action.

[0014] Another object of the present invention Is to propose a food preparation

with the above characteristics based on dairy foods and / or soybean and /

or rice, preferably In liquid or semi-fluid form.

[0015] Pollcosanols are a mixture of phyto-molecules consisting of high molecular

weight aliphatic alcohols extracted primarily from Saccharum officinarum,

but also from other plants, such as Medicago sativa. The main molecules

are Octacosanoi, Tetracosanol and Esacosanol. The octacosanol Is

contained in the above vegetables, in cotton, and in the waxy layer of

leaves of different plants, and Is also In a significant amount in wheat germ

oil. The policosanol can be produced synthetically but in this case they are

not accompanied by other phytochemicals normally present, so that they

are less effective than natural ones. In nature, for example, is always

accompanied by octacosanol and synergistic with vitamin E and vitamin

16 0 1 20 12 L U N 1 8 : 30 N° TX/ R X 5735 004 PatXML 4/23 Lp11646

Group B as well as minerals. The octacosanol extraction process is conducted by cold pressing, without using solvents, which allows to obtain a product rich in vitamin E, a powerful antioxidant factor.

[0016] Pollcosanol also have medicinal properties such as lowering the 'bad' cholesterol (LDL) through the reduction of an enzyme at the base of its production (H. Prat et al., 1999.), and the percentage of triglycerides (Mas R . et al., 1999), as well antiplatelet action on blood (R. Mas et al. 1998; Arruzazabala ML et al. 2002; G. Castano, R. Mas, JC Fernandez et al. ,

2001) reducing the risk of clogging the blood vessels. The pollcosanol also have important antioxidant functions and thus are effective in combating free radicals by preventing the oxidation of LDL which may be the root cause of atherosclerotic events.

[0017] Numerous clinical studies published up to now (I. Gouna-Berthold et al.,

2002) indicate that a dose of pollcosanol between 1 and 20 mg / day can lower total cholesterol between 17 and 21% and LDL cholesterol between 21 and 29% and raise HDL cholesterol between 8 and 12%; policosanol also reduce triglycerides by 10% on average. Recent studies have confirmed that policosanol Is as effective as simvastatin and pravastatin in lowering cholesterol. (Ortensi G., J. Gladstein, H. Valli et al, 1997). Further studies (Castano G. et al, 2003) have shown that the efficacy of policosanol In lowering cholesterol is only slightly less than that of atorvastatin.

[0018] This drug, which belongs to the so-called statins, is among the most

effective drugs on the market for lowering cholesterol and for the protection of the heart and blood vessels. Statins, chemically speaking, are secondary metabolites of polyketide nature having selective inhibitory action of the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA reductase) that catalyzes the reaction of the synthesis of endogenous cholesterol. Depending on the type of Interest in their pharmacological activity, processes have been developed for the production of statins by fermentation, using strains of fungi.

[0019] The study of the first isolated molecules and used within the drug

(lovastatin and mevastatina) made it possible to Identify other molecules

16 0 1 20 12 L UN 16 : 30 ° PatX L 5/23 Lp116 6

with greater biological activity and fewer side effects, eg. The provastatina.

The study (A. White, 2005) has also extended to the evaluation of the

Influence of fermentation parameters using strains of Monascus purpureus

that do not the problems of side effects associated with synthetic statins.

[0020] In fact, the ferment of red rice forms after the addition of Monascus

purpureus, a fungus that grows on the caryopsls of rice, giving him the

typical reddish, forming compounds known as monacolins: among them

the monacolin K, which is structurally related to lovastatln, one of the most

prescribed synthetic statins against cholesterol, and Just like this one It has

the same pharmacological Inhibiting action of KMG-CoA reductase, the

enzyme member of the cholesterol biosynthesis in the liver, so making the

reduction of plasma cholesterol.

[0021] The fermented red rice has long been the subject of detailed studies

reported in scientific literature which recognizes to the plant Oryza sativa

powerful cholesterol reducing properties. In fact, the therapeutic properties

of fermented red rice have been known for centuries in traditional Chinese

medicine. It is scientifically proven its ability to reduce levels of total

cholesterol, LDL - cholesterol and triglycerides.

[0022] Isoflavonea, policosanol and statins play so everyone, as amply

documented in the literature, stabilizing actions against dysllpidemla.

However, their action is certainly not identical, and although not yet

demonstrable and explicable in terms of bio-molecular process, the

inventor has found through experimentation that a balanced Intake of the

three substances in a single food preparation has stabilizing effect against

dysllpidemla which are enhanced compared to those that are the effects of

equal amounts of each of these substances taken Individually. In addition,

each of the three substances has additional health properties and act

synergistically together to produce, overall, significant protective effects of

the cardio-clrculatory, liver protection and antioxidants.

[0023] Coenzyme Q10, also known as ubiquinone or vitamin Q, is an organic

molecule, and more precisely a benzoqulnone with a very long Isoprene

side chain. This coenzyme, ubiquitous in biological systems, has a similar

structure to vitamin K and vitamin E. It is found in abundance in soybeans,

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grains, nuts and grapes. It participates In redox reactions In organisms. It

has a strong scavenging action and therefore protects cell structures from

free radicals, and its action is carried out in synergy with vitamin E, in turn

protected by coenzyme Q10, which ensures the link with the octacosanol,

also linked in turn to vitamins B group and minerals. In fact, this coenzyme

is a lipophilic compound Insoluble In water having an adjuvant action in

electron transport and mitochondrial energy production.

[0024] The Intake of coenzyme Q10 can exert cardioprotective effects,

cytoprotective and neuroprotective; It also carries an action of Inhibiting

oxidation of LDL cholesterol, which is considered the most pathogenic

component of atherosclerosis. (Littaru GP & L. Tiano, 2005; Llnnane AW

et al. 2002; M. Mizuno et al. 1997; Niklowitz P. et al„ 2002).

[0025] The coenzyme Q10 exerts an improvement of cellular energy production

and synthesis of adenosine triphosphate (ATP). The Q10 conezima thus

contributes to the Improvement of heart function In people suffering from

congestive heart failure and mitochondrial dysfunction and insufficient

cellular energy production.

[0026] The level of coenzyme Q10 in the human body decreases with age,

possibly due to a decrease In its synthesis or because of Increased lipid

oxidation with age. The coenzyme Q10, for Its therapeutic attitudes may

be Indicated In diseases related to cardiovascular disorders and, in

particular, congestive heart failure. It is definitely suited to meet the deficit

of CoQ10 caused by intake of inhibitors of HMG-CoA reductase used as

cholesterol reducing drugs, such as the above mentioned statins. These

can reduce the serum levels of coenzyme Q10 by up to 40%. Recent

studies suggest daily Intake of coenzyme Q10 in conjunction with all the

treatments that can reduce the natural production.

[0027] In view of this it is advantageous the use of this coenzyme in association

with pollcosanol and isoflavones, in place of the association of these active

Ingredients with green tea catechins (R. Fox, 2008).

[0028] The catechlns In green tea (Camellia sinensis), are polyphenols of the

flavan-3-oils belonging to the flavonoid family. The beneficial effects of

green tea have long been attributed to the catechln and in particular

1 6 / 0 1 20 1 2 L U N 1 6 : 30 [ N ° T X / R X 5735 ] @ 007 PatX L 7/23 Lp116 6 all'EGCG component (eplgallocatechln gallate) ranked as the most powerful antioxidant catechln In green tea. It was tested the ability of catechlns to induce Increased synthesis of certain phase II liver enzymes.involved in the detoxification of several xenoblotlcs, and among them also some chemical carcinogens. It was found that EGCG can Inhibit the proteolytic enzyme urokinase, an enzyme used by cancer cells to Invade healthy tissues and produce metastases. The assignment of antithrombotic effect seems to be attributed to the ability of inhibiting platelet aggregation without affecting coagulation parameters. However It is not clear the mechanism of the possible effect of reducing cholesterol levels. It is assumed, but this has not yet been confirmed by scientific studies, the catechins in green tea can stimulate the secretion of bile salts and fecal excretion of cholesterol.

[0029] The cynarln is the extract of Cynara scolymus (artichoke) which Is derived through crossing varieties and selections from the Cardo cardunculus (thistle). It is a herbaceous plant of the family of composite. Its medicinal properties were already known to the Greeks and Egyptians.

[0030] This is a plant rich In polyphenols, flavonoids and sterols, it is also rich in polyphenols and organic acids represented by the 5-caffeil chinic acid also known as chlorogenlc acid of 1.5-2-caffeil chinic acid.

[0031] The artichoke carries out a choleretic action hat Is Increases coleresys for synergistic action of organic acids and ctnaropicrina. It is also linked to this action the llpld-lowering effect: Increase of apollpoprotein A1 and A2 cell receptors by the liver with an increase In HDL. In addition, the artichoke σι uwl ■ Inhibiting she e r«l eynt **!* Wy inMlvltl n «f H

CoA reductase.

[0032] The beneficial effects of the artichoke stem from its significant content in has been demonstrated by numerous scientific studies. (FINTELMANN V., 1996, R. Gebhardt, 1997; T. Wegener et al., 1999). Therapeutic doses of cynarin vary from 5 g to 50 g. The substances contained In artichoke are absolutely devoid of toxicity.

[0033] The main chemical constituents of the artichoke are polyphenols,

e P T/IB2011/055716

PatXML 8/23 14)11646

polyaceta!s, sterols, acidim organic, mineral salts and aromatic volatile

components.

[0034] It was pointed out that the cynarin, long considered the key ingredient In

artichoke is actually not present In the plant during Its complete

phenological cycle, but it Is formed only during the drying process. From

this scientific discovery comes the use in the invention of cynarin obtained

from the dried plant.

[0035] As mentioned above, the policosanol can be found, in addition to

Saccharum officinarum, also In Medicago sativa, which also contains

Isoflavones, saponins, coumarins and folic acid. The saponins, glycosides,

or saponins, are complex molecules characterized by a aglyconic structure

of trlterpenic or steroidal nature. They are responsible for the

cholesteroplasic activity through which total cholesterol and LDL

cholesterol are significantly reduced. The coumarins are, in chemical

terms, derivatives of 5,6-benzo-2-plrone and can be found In the plant

world both In free form and in glycosides, le linked as an aglycone to a

sugar. Thanks to a certain thrombosis reducing that it has, Medicago

sativa helps the prevention and treatment of cardiovascular system.

Moreover, thanks to Its significant content of folic acid, or pteroll (mono)

glutamic acid or vitamin B9, It exerts a competitive containment of

homocysteine.

[0036] Homocysteine is an amino acid of great Interest for the scientific research

for medical risk which may result in an excess of It In our body. In fact the

etiology of many human diseases is attributed to It. The term

hyperhomocysteinemia indicates an excessive amount of blood

homocysteine. Hyperhomocysteinemia is considered an important and

(atherosclerosis, myocardial Infarction), cerebrovascular (stroke) and

, It.is f»s†lma†»H that

twice the chance of

running into cardio vascular disease compared to those who have values

within the normal range. Many studies report that the

hyperhomocysteinemia represents a high risk of developing Alzheimer's

16/ 0 1 201 2 L U N 16 : 30 N° TX / R X 5735 003 PatXML 9 23 Lp11646 disease, and It was also observed a high blood level of homocysteine In women with preeclampsia, placental detachment, and miscarriage. High blood levels of homocysteine have also been reported In women who have given birth to underweight children or with neural tube defects.

Hyperhomocystelnemia can be considered a predisposing factor for the occurrence of osteoporosis. The vast majority of people with

hyperhomocysteinemla follows a diet incorrect and deficient In B vitamins including folic acid.

[0037] A diet rich In vegetables brings the right amount of folate. Some

researchers argue that hyperhomocysteinemla, is one of the few If not the only condition which can be adequately treated with vitamin

supplementation. In fact we know that there are various 5 vitamins Involved In homocysteine metabolism. Several studies confirm that the proper daily Intake of B vitamins Is able to decrease the plasma levels of homocysteine. Some studies have observed a significant reduction In plasma levels of this amino acid after folic acid intake. It has been shown that a daily folic acid supplement leads to a reduction of about 60% homocysteine, and If the dose doubles, the reduction Increases to about 80%.

[0038] The folic acids are essential for the synthesis of certain amino acids, for the synthesis of purines and pyrimidlnes, for the reproduction and growth of cells, particularly of red blood cells. Folic acid participates In nucleic acid synthesis. It Is present in milk, potatoes, medical grass, carrots, spinach, green beans, asparagus, wheat germ, yeast, liver, chicken, eggs. Studies have shown that folic acid is a nutrient most often deficient In the diet. Its deficiency leads to increased homocysteine in the blood, leading to a significantly increased risk of ischemic heart disease. According to nUmerUUS Ullf ai l aUIUOI I IIb

the diet results in significant actions to reduce disease with heart disease fncreasTng th¾ ft&fe . B12 can cause in turn an additional folic acid deficiency which can cause the onset of anemia. Oral contraceptives interfere with the absorption of

° PatXML 10/23 Lp11846 folic acid. The lipid-lowering drugs, the adamantine, barbiturates, cause a reduction of folic acid in the body. The need for folic acid increases considerably during pregnancy. Studies show that most of the metabolic imbalances or neural tube defects are caused by folic acid deficiency, which can lead to severe deformities in the fetus as a cleft palate, brain damage, spina bifida, slowing growth and learning ability of child. Studies confirm that folic acid should be taken with the diet and that women should take six weeks before conception. Studies show that folic acid deficiency can cause toxemia, premature delivery, postpartum hemorrhage and anemia megaloblastic both to the mother and child. Deficiencies in folic acid, during and after pregnancy, determine the increased risk of cancer or cervical dysplasia. The edlcago sativa has a high content of folic acid, which among other things, works by interfering with the decrease of homocysteine in the blood Increased as a result of inhibition of the enzyme action H CoA-reductase determined, in turn, by the action of monacolin K, plant statin of onascus purpureus, developed during fermentation of Oryza sativa.

[0039] Polyphenols are a family of about 5000 organic molecules widespread in the plant kingdom. They are characterized, as Its name indicates, by the presence of multiple phenolic groups associated In more or less complex structures generally of a high molecular weight. In nature, the polyphenols are produced by secondary metabolism of plants, where, In relation to the chemical diversity that characterizes them, cover different roles; defense against herbivores (imparting

unpleasant taste) and pathogens (phytoalexlns), mechanical support

(llynlns) ariU Lia lei ayali iaL li ilwulilal iuvoalui i, allreotli-19 pollinators and dispersal of the fruit (anthocyanlns), Inhibitors of in competition plants growth. From the chemical point of view, the polyphenols are molecules composed of multiple condensed phenolic cycles (organic compounds that possess one or more hydroxyl groups - OH - bound to an aromatic ring). Depending on their structure they can be schematically divided into three different classes: simple phenols, flavonoids, and tannins.

[0040] An Important, in terms of healthy, polyphenol present In grapes and wine is

° PatXML 11/23 Lp11646

Resveratrol.

[0041] Many in vitro studies have confirmed that the Resveratrol molecule plays an important role In the prevention of human diseases and In maintaining optimal physiological balance essential for leading a peaceful and healthy life.

[0042] Mainly, the protective effect of Resveratrol against cardiovascular disease has been demonstrated as well as the action of slowing the evolution of cancer, the fundamental role as antioxidant agent and the action for containing the blood cholesterol. Recently It was discovered a very important action of Resveratrol as an activator of intetieukin 10 (IL10) which suggests to the scientific community that It is an activator of immune tolerance and control of allergies.

[0043] Another discovery has attributed to Resveratrol the role of deactivator of the NFKappa-B protein, which has a protection of cancer cells by chemotherapy and hinders their destruction. This discovery opens a therapeutic setting of great importance especially in the use of Resveratrol during chemotherapy to protect the body and contribute to more active therapy. Resveratrol can also be used as anti-infective and it was found that in some cases it is useful where some antibiotics are no longer able to function. Finally, Resveratrol has recently been attributed the effect of improving the quality of the skin. Several studies have shown that this substance helps to restore tone and clarity, in addition to significantly counteract the signs of aging. This is due to the combination of its anti-Inflammatory and antioxidant. Its vessel relaxing properties results in a significant Improvement of blood microcirculation, which Involves revitalizing the skin while making It more elastic.

[0044] The protective action of Resveratrol on the cardiovascular system is

attributed to Its antioxidant action and its inhibition of platelet aggregation, which is accomplished through inhibition of the synthesis of eicosanoids and by the action on the metabolism of arachldonic acid. Resveratrol also plays protective action of oxidation of LDL and lipoprotein responsible for transporting cholesterol to the body's cells. Taking Resveratrol exerts an action to reduce levels of total cholesterol and a reduction of fat in the Pa XML 12/23 Lp1l6 6

blood. In particular, we found a significant lowering of blood levels of

VLDL, which, among the different types of LDL, are those mainly

responsible for the onset of atherosclerosis.

[0045] Resveratrol has a chemical structure similar to that of dlethylstilbestrol, a

synthetic estrogen, and this explains its hormone-like activity that allows it

to bind and activate estrogen receptors competitively.

[0046] Due to Its estrogenic effect on cholesterol levels and blood flow, several

researchers attribute to Resveratrol the actions of prevention of

cardiovascular disease. In addition, promoting the physiological

mechanism mediated by nitric oxide, resveratrol is able to Induce vessel

dilation leading to a lowering of blood pressure. Resveratrol can also play

anti-Inflammatory activity through Inhibition of cyclooxygenase and

hydroperoxidases.

[0047] The Berberine is a plant alkaloid particularly active In reducing cholesterol.

This substance, with Its bitter taste and yellow color, is present in the bark,

roots and stems, including underground (rhizomes) of plants of the genus

Berberis, such as barberry (Berberis vulgaris L).

[0048] Berberin Is also typical of hydraste berberine (Hydrastis canadensis) and

Huang Lian (Coptls chinensls).

[0049] For the antisecretory and antimicrobial properties attributed to berberine,

the traditional use of berberine addressed the treatment of infections of

various kinds, such as bacterial diarrhea and recurrent Infections by

Candida albicans. Recently, there have been documented and

reevaluated especially cholesterol-lowering and hypoglycemic properties

of berberine. In this sense, the drug has risen to the headlines In 2004,

with the study published In Nature Medicine by Kong, Wei J, Abidi et al.

(Berberine is a novel cholesterol-Lowering drug working through a unique

mechanism distinct from statins). During this research berberine, taken

orally by 32 hypercholesterolem!c patients for three months, reduced

plasma cholesterol by 29%, triglycerides by 35% and LDL cholesterol by

25%. The above data is particularly encouraging, therefore leading to

attribute to Berberine properties that make it a possible alternative to statin

therapy that can cause side effects. The mechanism by which this drug

1 6 /0 1 20 1 2 L U N 1 6 : 30 N ° T X / R X 5735 l 0 1 3 PatXML 13/23 Lp 1646 reduces the plasma levels of cholesterol, however, differs from the one carried out by statins. While these drugs decrease the synthesis of endogenous cholesterol, berberine increases the activity and the number of hepatic LDL receptors, facilitating the removal of 'bad cholesterol' from blood. The combination of berberine with statins may still produce an interesting synergistic effect, also for its ability to inhibit a protein (PCSK9) responsible for the partial degradation of LDL receptors in the liver (which tend to promote statins).

[0050] More recently, new studies have highlighted the hypoglycemic effect of Berberine in patients with diabetes mellitus type 2. Also In this sense, the substance seems to act primarily at the receptor, increasing the

expression of receptors for the insulin, with Increased sensitivity to this hormone, and reduction of insulin resistance.

[0051] According to the present Invention, the above objects are achieved thanks to the solution mentioned specifically in the following claims. In relation to the invention, the claims are an Integral part of technical teaching provided.

[0052] The invention is explained below in detail with non-exhaustive examples of realization of the functional food preparation of the Invention. [Example 1

[0053] For the purpose of stabilizing the levels of cholesterol and triglycerides has been effective the synergistic action of soy isoflavones associated with policosanol, including octacosanol, extracted from Saccharum offlclnarum, statin plant monacolin K by Monascus purpureus extract, coenzyme Q10 and also extracted from soybean (Glycine max), which have been added to a dairy product, and exactly yogurt, where out of 100 grams in total weight of the preparation there are:

^• Saccharum offlclnarum (drums - titled 60% In octacosanol) 35 mg

• Monascus purpureus (yeast Monascus fermented substrate Purpureus Oryza satlva titled 1.5% in monacolin) 200 mg

• Glycine max (beans title 40% in isoflavones) 70 mg

' Dairy Product semifluid- especially yogurt - to reach 100g In total.

where the Saccharum officinarum and fermented red rice are added to the milk after 20 minutes of cooling following the pasteurization process and PatXMU 14/23 Lp11646 the Glycine max ie added to the milk after 30 minutes of cooling In a multi-purpose apparatus commonly known in the dairy sector.

[0054] In this example, Saccharum officinarum brings the amount of daily

recommended policosanol (Octacosanol), the Oryza satlva brings statin monacolln K and Glycine max provides Isoflavones and coenzyme Q10. In addition to achieving optimal doses of policosanol, Isoflavones and plant statins, coenzyme Q10 Is used to cover the deficit of CoQ10 caused by Intake of inhibitors of HMG-CoA reductase inhibitors used as cholesterol reducing drug, such as the above mentioned statins. Example 2

[0055] A second example of implementation of the invention has been developed and defined in view of individual metabolic exceptions, which can offer a different and significant cholesterol-lowering response to food Intake In which there is the association of soy isoflavones associated with policosanol , Including octacosanol, plant statins extracts from Medicago satlva, the cynarin extracted from Cynara scollmus, and coenzyme Q10 extracted from soybean (Glycine max), which are added to a dairy product, and exactly yogurt, where on 100 grams in total weight of the preparation there are:

• Medicago satlva (dried extract) SO mg

^• Cynara scollmus (purified dry extract titled 5% in cynarin) 10 g

» Glycine max (beans - titled 40% in isoflavones) SO mg

' Monascus purpureus (yeast ofMonascus Purpureus fermented on a substrate of Oryza satlva titled 1.5% In monacolin) 200 mg

• Dairy Product semifluid - exactly yogurt - to reach 100g in total, where the above mentioned substances are added to the milk after 30 minutes of cooling following the pasteurization process by making use of multi-purpose apparatus.

[0056] In this example, policosanol are contained in Medicago satlva, monacolin K is contained in Oryza satlva, while isoflavones and coenzyme Q10 are uuiiLalneU In Oly no Ι Ι ΙΛΛ. thanko to Ita significant content In folic acid, or acid pteroll (mono) glutamic acid or vitamin B9, the Medicago sativa exerts a containment of homocysteine. The main contribution of Cynara scollmus Is in cynarin that, in addition to cholesterol-lowering

° PatXML 15/23 Lp11646 action also plays an Important action to protect the liver. Example 3

[0057] In a third example of realization of a food preparation according to the invention the synergistic action of policosanol, isofiavones, plant statins and coenzyme Q10 are combined with the actions of Resveratrol and Berberine. In this example of realization the above active ingredients are added in the form of dry extracts of specific plant varieties to a rice based drink In which, out of 100 grams in total weight of the preparation are:

• Saccharum officinarum (drums - tiffed 60% In octacosanol) 35 mg

• Berbaris sristeta (dry extract 97% In berberine) 500 mg

' Glycine max (beans titled 40% in isot!avones) SO mg

• Monascus purpureus (yeast Monascus Purpureus fermented on a substrate ofOryza satfva titled 1.5% in monacolin) 200 mg

' Wis vinlfera (seed dry extract titled 90% in Resveratrol) SOOmg

• rice milk (rice grains soaked in water, with added enzymes, pressed and filtered) to reach 100g in total

where the plant extracts listed above are added at the end of the process of production of the rice milk.

[0058] In this realization in addiction to policosanol, isofiavones, statins and

coenzymes are Resveratrol and Berberine. While statins reduce the synthesis of endogenous cholesterol, berberine increases the activity and the number of hepatic LDL receptors, thus facilitating the removal of 'bad cholesterol ¹ from blood. The results obtained show that the combination of berberine with statins may still produce an interesting synergistic effect, also for Its ability to inhibit a protein (PCSK9) responsible for the partial degradation of LDL receptors in the liver (that statins tend to promote).

[0059] The preparation of the Invention is preferably a dairy product based on milk that has undergone at least a pasteurization or equivalent.

[0060] For semi-liquid dairy product means a product which has a viscosity (at 10

^• C) less than 10.000 mPa*s.

[0061] Alternatively, the food preparation of the invention can be a soy drink or a rice drink.

[0062] Information and definitions relating to substances used in the preparation examples described above are shown below.

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[0063] Saccharum ofRclnarum (sugar cane):

• contains policosanol, octacosanol in particular

• 0.5% protein content

• 0.2% fat

• 95% carbohydrates

• 0,005% Iron

[0064] Monascus purpureus (yeast red rice) (yeast Monascus Purpureus

fermented on a substrate ofOryza satfva titled 1.5% in monacolln/

• 1.5% monacolin

• 5% Policosanols

• 2.5% Astaxanthin

• 2.5% Coenzyme Q10

•0.1% Folic acid

• 0.001% Vitamin B12

• 8.8% protein content

• 2.75% fat

• 60% carbohydrates

• 1.04% fibers

•2.21% ash

•21% amidoiso

[0065] Glycine max (soybean/.

• contains isoflavones, coenzyme Q10

^• 13.09% protein content

• 6.7% fat

• 9.7% carbohydrate

• 1.1% fiber

• 69% water

• 1.59% ash

• 0.464% potassium

• 0.174% phosphorus

[0066] Medlcago sativa (lucerne.

• contains isoflavones, policosanol, saponins, coumanns, folic acid

• 26% protein content

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• 0.2% fat

• 61% polysaccharides

■ 23.7% fiber

• 4.9% starch

• 12.3% lignin

• 9.3% ash

• 37.9% nitrogen free extract

[0067] Cynara scolimus (artichoke)

• contains cynarin, folic acid, Sylmarin, vitamin C

• 2.7% protein content

• 0.2% fat

• 2.5% carbohydrate

^• 1.1% fiber

• 84% water

[0068] The dairy products used in the context of the invention are milk, yogurt, butter, fresh cheese, mozzarella, crescenza cheese, rlcotta cheese, cottage cheese, quark, mascarpone cheese, single-portion fresh cheese, via and matured cheeses.

[0069] The milk used In the production of the above dairy products may be of a variety of types, and can be chosen from cow's milk or sheep's or goat's milk or buffalo milk or mixtures thereof, or it could also be a milk plant as soy milk or rice milk.

[0070] The milk itself, when It comes from animal milk, preferably has undergone a process of pasteurization, sterilization or other heat treatment.

[0071] Preferably, yogurt means cow's milk fermented with Lactobacillus b

ulgaricus and Streptococcus thermophilus, where these organisms are alive and vital to the moment of consumption. The cell density must be equal to or greater than 100,000,000 cells per milliliter. The enzymes can also be problotlc, such as bifidobacteria and lactobacltli acidophilus.

However, the yogurt may also be obtained from plant milk such as the soy milk.

[0072] The form of coenzyme Q10 that Is used in the Invention is extracted from the oil of Glycine max (soybean) with the Soxhlet method, a known

° PatXML 18/23 Lp11646

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