BACKGROUND

[0001] High triglyceride levels are associated with genetically-, diet-, and alcohol- induced fatty liver, hyperlipidemia or hyperlipoproteinemia, and contribute to risk of developing pancreatitis. Lowering the high levels of triglycerides can alleviate symptoms of fatty liver and prevent cirrhosis of the liver. Lowering low-density lipoprotein (LDL) cholesterol levels and increasing high-density lipoprotein (HDL) cholesterol levels can reduce the risk of cardiovascular disease. Non-alcoholic fatty liver disease, which is accumulation of excessive fat in liver cells that is not caused by alcohol, tends to develop in overweight or obese people, people with diabetes, and people having high cholesterol or high triglyceride levels. For animals such as livestock, fish and poultry, the accumulation of excessive fat in the liver leads to fatty liver and weakens their ability of resistance to diseases.

[0002] According to some studies, niacin (pyridine-3 -carboxylic acid, also known as vitamin B3, or vitamin PP) functions in vivo after conversion to nicotinamide adenine dinucleotide in the nicotinamide adenine dinucleotide (NAD) coenzyme system. Niacin consumption can lower total cholesterol, LDL cholesterol, triglycerides and increase HDL cholesterol. Niacin consumption can also lower high blood pressure. The mechanism by which niacin changes lipid distribution has not been clearly defined, and may include partial inhibition of release of free fatty acids from adipose tissue and increased lipoprotein lipase activity, which may increase the rate of removal of particulate triglycerides from plasma.

[0003] Niacin ingredient as a dietary supplement is generally regarded as safe (GRAS) by the United States Food and Drug Administration (FDA). Niacin is rapidly and extensively absorbed (at least 60 to 76% of the amount) after oral administration. However, in order to maximize bioavailability and reduce the risk of gastrointestinal disorders and skin flush, it is recommended to give low-fat meals or snacks. Minimum 500 mg dosage up to 1 g of niacin such as in the forms of pill or capsules, Niacin, Niaspan, Nicolar, Wampocap, etc. have been approved by the FDA as prescription drugs to treat cardiovascular disease and also effectively reduce triglyceride levels. However, such high dosages often lead to

gastrointestinal complaints, and in some cases skin flush.

[0004] Distribution of radiolabeled niacin in mice showed that niacin and its metabolites were concentrated in liver, kidney and adipose tissue. The pharmacokinetic profile of niacin is complex, and is species-specific and dose-rate specific. In humans, one pathway involves the formation of niacin with glycine via simple conjugation steps and excretion in urine, albeit there may be a reversible metabolism for those metabolites to return to niacin. However, vast majority of niacin and its metabolites are rapidly eliminated from the system.

[0005] Currently niacinamide (or nicotinamide, also commonly referred to as niacin, and often used interchangeably with vitamin B3, or vitamin PP), rather than niacin, is commonly used as food and beverage additives and dietary supplements for healthy human in energy drinks due to its benign vasodilation effect of niacin that in some occasions cause the so-called harmless“skin flush”. However, niacinamide itself does not have the ability to lower total cholesterol, LDL cholesterol, triglycerides, and increase HDL cholesterol.

[0006] The recommended daily value of niacin is 16 mg for men or 14 mg for women. However, 70-88% of orally absorbed niacin are initially excreted rapidly with urine, resulting in low niacin intake that cannot provide sufficient amount of bioavailable niacin nutrients to those suffering with high triglyceride and high cholesterol symptoms. Hence, for niacin to be able to function as an effective dietary supplement, higher than daily value is desirable.

SUMMARY

[0007] The present invention provides a dietary supplement formula that can beneficially provide a user with a significant fraction of niacin and various other nutritional components without causing undesirable health effects.

[0008] In an embodiment, a dietary supplement formula including a food carrier and niacin distributed in the food carrier is provided.

[0009] The food carrier may be a solid food carrier. The solid food carrier may include ground coffee beans, water-soluble coffee powder, whole tea leaves, ground tea leaves, water-soluble tea extracts, spices, herbs, or a combination thereof.

[0010] The food carrier may be a liquid food carrier. The liquid food carrier may include coffee extract, tea extract, soft drinks and their concentrates.

[0011] The food carrier may be an animal food or an animal feed.

[0012] An amount of niacin may be from about 0.001 part by weight to about 100 parts by weight based on 100 parts by weight of the dietary supplement formula.

[0013] The dietary supplement formula may further include a natural sweetener, a sugar alcohol, an artificial sweetener, a mineral element, a nutraceutical, a vitamin, a nutraceutical such as food additives and herbs, an amino acid, a peptide, a dietary fiber such as cellulose, resistant starch, resistant dextrins, inulin, lignins, chitins, pectins, beta-glucans and oligosaccharides such as fructooligosaccharide (FOS) and xylooligosaccharide (XOS), a polysaccharide such as maltodextrin, a prebiotic, or a combination thereof. The natural sweetener may be sucrose, fructose, stevia extracts, tagatose, trehalose, agave nectar, date sugar, fruit juice concentrate, honey, maple syrup, molasses. The sugar alcohol may be erythritol, hydrogenated starch hydrolysate, isomalt, lactitol, maltitol, mannitol, sorbitol, xylitol. The artificial sweetener may be sucralose, aspartame, advantame, acesulfame potassium, neotame, saccharin. The mineral element may be calcium, phosphorus, potassium, sodium, magnesium, sulfur, iron, chlorine, cobalt, copper, zinc, manganese, molybdenum, iodine, selenium. The vitamin may be thiamin (vitamin Bl), riboflavin (vitamin B2), niacinamide (vitamin B3), pyridoxine (vitamin B6), folate (folic acid), vitamin B12, biotin, pantothenic acid, and ascorbic acid (vitamin C), any derivative thereof, or any combination thereof. The nutraceuticals or food additives may be acidulants such as vinegar, citric acid, tartaric acid, malic acid, fumaric acid, and lactic acid, acidity regulators, anticaking agents, antifoaming and foaming agents, antioxidants, bulking agents such as starch, food coloring, color retention agents, emulsifiers, flavors, flavor enhancers such as monosodium glutamate, flour treatment agents, glazing agents, humectants, tracer gas, preservatives, stabilizers, thickeners and gelling agents such as agar or pectin, and thickeners. The herbs may be acai, aloe vera, Asian ginseng, astragalus, bilberry, bromelain, chamomile, chasteberry, cinnamon, cranberry, dandelion, echinacea, European elder, European mistletoe, evening primrose oil, fenugreek, feverfew, flaxseed and flaxseed oil, garcinia, garlic, ginger, ginkgo, goldenseal, grape seed extract, hawthorn, hoodia, horse chestnut, kava, lavender, licorice root, milk, thistle, noni, passionflower, peppermint oil, pomegranate, red clover, rhodiola, sage, saw palmetto, soy, St. John's wort, tree oil, thunder god vine, turmeric, valerian, yohimbe.

[0014] In another embodiment, a package comprising the dietary supplement formula is provided. In the package, an amount of niacin in the dietary supplement formula may be from about 0.1 milligrams to about 500 milligrams, for example, about 1 milligram to about 500 milligrams, about 10 milligrams to about 500 milligrams, or about 100 milligrams to about 500 milligrams. The package may be a sealed bag, a sealed packet, a sealed bottle, a sealed cup, or a sealed pouch. The package may be a formulation selected from a soft capsule, a hard capsule, a tablet, or a granule.

[0015] Also in the package, an amount of niacin in the dietary supplement formula may be about 400 milligrams or less, for example, about 300 milligrams or less, about 200 milligrams or less, or about 100 milligrams or less. [0016] In another embodiment, a method of lowering plasma triglyceride levels in a subject having elevated plasma triglyceride levels is provided. According to the method, a dietary supplement formula including a food carrier niacin distributed in the food carrier is provided, and an effective amount of the dietary supplement formula is administered to the affected subject.

[0017] In another embodiment, a method of lowering plasma low-density lipoprotein levels in a subject having elevated plasma low-density lipoprotein levels is provided.

According to the method, a dietary supplement formula including a food carrier and niacin distributed in the food carrier is provided, and an effective amount of the dietary supplement formula is administered to the affected subject.

[0018] In another embodiment, a method of alleviating the fatty liver symptoms in a subject in need thereof is provided. According to the method, a dietary supplement formula including a food carrier and niacin distributed in the food carrier is provided, and an effective amount of the dietary supplement formula is administered to the affected subject.

[0019] In the above methods, the providing a dietary supplement formula may be followed by contacting the dietary supplement formula with water to provide an extract of the food carrier comprising niacin prior to the administering to the subject an effective amount of the extract.

[0020] In the above methods, the providing a dietary supplement formula may include providing a package comprising a dietary supplement formula.

[0021] Also in the above methods, the providing a dietary supplement formula may include mixing niacin and the food carrier.

DETAILED DESCRIPTION

[0022] Reference will now be made in detail to exemplary embodiments. In this regard, the exemplary embodiments may have different forms and should not be construed as being limited to the descriptions set forth herein. Accordingly, the embodiments are merely described below to explain aspects of the present disclosure. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

[0023] It will be understood that when an element is referred to as being“on” another element, it can be directly in contact with the other element or intervening elements may be present therebetween. In contrast, when an element is referred to as being“directly on” another element, there are no intervening elements present. [0024] It will be understood that, although the terms first, second, third, etc., may be used herein to describe various elements, components, regions, layers, and/or sections, these elements, components, regions, layers, and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer, or section from another element, component, region, layer, or section. Thus, a first element, component, region, layer, or section discussed below could be termed a second element, component, region, layer, or section without departing from the teachings of the present embodiments.

[0025] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms“a,” “an,” and“the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0026] The term“or” means“and/or.” It will be further understood that the terms “comprises” and/or“comprising,” or“includes” and/or“including” when used in this specification, specify the presence of stated features, regions, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and/or groups thereof.

[0027] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this general inventive concept belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure, and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0028] The terms "substantially" and "about" as used herein are inclusive of the stated value and mean within an acceptable range of deviation for the particular value as determined by one of ordinary skill in the art, considering the measurement in question and the error associated with measurement of the particular quantity ( i.e ., the limitations of the

measurement system). For example, "substantially" or "about" can mean within one or more standard deviations, or within ± 30%, 20%, 10%, 5% of the stated value.

[0029] Niacin (pyridine-3 -carboxylic acid) plays an important role in the metabolism of proteins, fats and carbohydrates into energy. It is also known to promote a number of other health benefits, such as decreasing the risk of coronary artery disease. Niacin is present in a number of natural and non-natural sources, and is rapidly and extensively absorbed after oral administration. A dosage of 500 mg to 1 g of niacin has been approved by the FDA to treat cardiovascular diseases by effectively reducing triglycerides and low-density lipoprotein (LDL) levels in the plasma of the affected subjects. However, such high dosages often lead to gastrointestinal complaints, and in some cases, may cause skin flush. The present invention addresses this problem by providing dietary supplement formulas that includes a food carrier and niacin distributed in the food carrier.

[0030] As used herein, the term“food carrier” refers to an item of food or a beverage which may serve as a vehicle for oral delivery of niacin to a subject in need thereof. The food carrier may be an edible item of food, such as breads, biscuits, cereals, various vegetables, sauces, mustard, confectionary products, noodles, rice, soups, oatmeal, energy bars, yogurts, ice cream, milk and dairy products, meat and cheese products, but not limited thereto. The food carrier may be animal feed, for example, a livestock feed, a poultry feed, or a fish feed. The food carrier may also be an item of food which is not edible per se , but which may produce edible extracts upon treatment with water, such as ground coffee beans, whole tea leaves, or ground tea leaves. The food carrier may also be a beverage, such as water, juice, or cocktail, which may be non-alcoholic or alcoholic. Niacin may be added to a wide variety of food carriers without significantly altering their taste, odor, and consistency.

[0031] The food carrier may be an item of food that is recognized as safe for consumption by a user. The food carrier may be a solid food carrier or a liquid food carrier.

[0032] In some embodiments, the solid food carrier may be any solid item of food capable of being mixed with niacin. A suitable solid food carrier may also include any odorless and flavorless solid medium that is recognized as safe for consumption by a user. In an embodiment, a suitable solid food carrier may include, for example, nutrient delivery vehicles such as starches, cellulose and modified cellulose derivatives, sugars, sugar alcohols, gelatin, and the like. Use of a solid medium may be desirable when uniform mixing of niacin with a food carrier is not necessary. For example, a dietary supplement formula prepared may be prepared by sprinkling a powdered or granulated niacin to a food carrier as a condiment or topping.

[0033] Upon mixing, niacin becomes dispersed in the solid food carrier. In an embodiment, the solid food carrier may be an item of food which is not consumed per se , but which produces an extract upon contact with water, that is used for consumption. Non limiting examples of such items include ground coffee beans, water-soluble coffee powder, whole tea leaves, ground tea leaves, or herbs such as ginger powder, each of which may be pre-mixed with niacin to form a dietary supplement formula. Upon contact with water, the dietary supplement formula produces a coffee or tea extract containing niacin, which may be used for consumption by a user.

[0034] In other embodiments, the food carrier may be a liquid food carrier, for example, a beverage. A suitable liquid food carrier may include any odorless and flavorless liquid medium that is recognized as safe for consumption by a user. In an embodiment, the liquid carrier may include water, which may be bottled water, mineral water, sparkling water, tap water, and the like. Water can be a particularly advantageous liquid food carrier due to its own health benefits and the ready solubility of niacin and other various food-related components therein. In some embodiments, the liquid food carrier may include a mixture of water and an organic solvent. Suitable organic solvents that may optionally be present in a liquid food carrier containing water include, for example, ethanol, glycerol, polyethylene glycol, and the like. By pre-dissolving or dispersing niacin in a liquid food carrier, a user can obtain a more uniform mixing of niacin in an item of food.

[0035] The liquid food carrier may be a beverage, for example, a tea or coffee, which may be hot or cold. The liquid food carrier may include non-alcoholic carbonated beverages, fruit juices, vegetable juices, milk, or sports drinks. The liquid food carrier may also include a cooking oil, a salad dressing, a condiment, a soup, and the like. Because niacin does not significantly change the taste and/or odor of the solid or liquid food items, these food items may be enjoyed by a user in substantially the same manner as that of their everyday consumption.

[0036] In some embodiments, the dietary supplement formula described herein may include a coffee bean extract, a tea extract, or any combination thereof. The coffee bean extract may be a green coffee bean extract. The tea extract may be an extract of white tea, green tea, black tea, yellow tea, oolong tea, and the like. The tea may be caffeinated or decaffeinated, and may be prepacked in tea bags or canned. The tea may be bottled tea, iced tea, but is not limited thereto. The herbal extract may be an extract of ginger powder, chamomile, but is not limited thereto.

[0037] In some embodiments, the dietary supplement formula described herein can contain a tea extract. A tea extract is a herbal derivative of tea leaves, which contains a number of antioxidant compounds, mainly catechins, also known as tea polyphenols.

Illustrative but non-limiting examples of tea polyphenols can include, for example, epigallocatechin gallate (EGCG), epigallocatechin, epicatechin gallate, and epicatechin. Of these, EGCG is the primary constituent of a green tea extract. Other constituents of a tea extract can include, but are not limited to, caffeine and flavonoids such as, for example, kaempferol, quercetin and myricetin. In some embodiments, a tea extract may contain low amounts of caffeine or may be substantially caffeine free. Tea and its derivatives have long been considered a natural material that can promote beneficial health effects in a user.

Without being bound to a particular theory or mechanism, it is believed that the catechins of a tea extract may activate phosphodiesterase to produce beneficial health effects. In some embodiments, the dietary supplement formula described herein can contain up to about 0.05% of the tea extract by weight. In some embodiments, the dietary supplement formula can contain up to about 0.04% of the tea extract by weight, or up to about 0.03% of the tea extract by weight, or up to about 0.02% of the tea extract by weight, or up to about 0.01% of the tea extract by weight. In some embodiments, an amount of the tea extract in the dietary supplement formula may range between about 0.005% to about 0.1% (weight to volume, w/v) of the dietary supplement. In some or other embodiments, an amount of the tea extract in the dietary supplement formula may range between about 0.008% to about 0.08% weight by volume (w/v) of the dietary supplement, or between about 0.01% and about 0.05% (w/v) of the dietary supplement, or between about 0.01% and about 0.03% (w/v) of the dietary supplement.

[0038] In some embodiments, the tea extract may include about 90% or less polyphenols by weight. In other embodiments, the tea extract may include about 80% or less polyphenols by weight, or about 70% or less polyphenols by weight, or about 60% or less polyphenols by weight, or about 50% or less polyphenols by weight, or about 40% or less polyphenols by weight, or about 30% or less polyphenols by weight, or about 20% or less polyphenols by weight, or about 10% or less polyphenols by weight.

[0039] Although the dietary supplement formula described herein may be

substantially odorless and flavorless, it is to be recognized that in alternative embodiments, the dietary supplement formula may be formulated to possess either an odor or a flavor. In some embodiments, various spices, flavorants, and enhancers that will be familiar to one of ordinary skill in the art may be present in the dietary supplement formula described herein.

In some or other embodiments, sugars and/or other carbohydrates may optionally be present in the dietary supplement formula. Sugars and other carbohydrates, in particular, may provide additional energy to a user and/or improve the taste of a food carrier to which niacin is being applied. Although sugars or other carbohydrates may impart a flavor to the dietary supplement formula in some embodiments, it is to be recognized that in other embodiments, the quantities of these substances may be sufficiently small that the flavor of the dietary supplement formula is not substantially altered.

[0040] In related embodiments, an artificial sweetener may be present in the dietary supplement formula for purposes similar to those in which a sugar or other carbohydrate is included. In some embodiments, the artificial sweetener stevia can be included in the dietary supplement formula. Stevia can be a particularly desirable artificial sweetener in this regard, since it is derived from natural sources and is generally recognized as safe.

[0041] The dietary supplement formula may further include a mineral element. A mineral element is a chemical element required as an essential nutrient by organs to perform functions necessary for life. Most chemical elements that are ingested by organisms are in the form of simple compounds. Non-limiting examples of mineral elements include potassium, chlorine, sodium, calcium, phosphorus, magnesium, iron, zinc, manganese, copper, iodine, chromium, molybdenum, selenium, and cobalt.

[0042] The dietary supplement formula may further include a nutraceutical. A nutraceutical is an item of food containing health-giving additives and having medicinal benefit. Non-limiting examples of nutraceuticals and food additives include acidulants such as vinegar, citric acid, tartaric acid, malic acid, fumaric acid, and lactic acid, acidity regulators, anticaking agents, antifoaming and foaming agents, antioxidants, bulking agents such as starch, food coloring agents, color retention agents, emulsifiers, flavors, flavor enhancers such as monosodium glutamate, flour treatment agents, glazing agents,

humectants, tracer gas, preservatives, stabilizers, thickeners and gelling agents such as agar or pectin, and thickeners. The herbs may be acai, aloe vera, Asian ginseng, astragalus, bilberry, bromelain, chamomile, chasteberry, cinnamon, cranberry, dandelion, echinacea, European elder, European mistletoe, evening primrose oil, fenugreek, feverfew, flaxseed and flaxseed oil, garcinia, garlic, ginger, ginkgo, goldenseal, grape seed extract, hawthorn, hoodia, horse chestnut, kava, lavender, licorice root, milk, thistle, noni, passion flower, peppermint oil, pomegranate, red clover, rhodiola, sage, saw palmetto, soy, St. John's wort, tree oil, thunder god vine, turmeric, valerian, yohimbe.

[0043] The dietary supplement formula may further include a vitamin. In some embodiments, the dietary supplement formula may contain one or more of thiamin (vitamin Bl), riboflavin (vitamin B2), niacinamide (vitamin B3), pyridoxine (vitamin B6), folate (folic acid), vitamin B 12, biotin, pantothenic acid, ascorbic acid (vitamin C), any derivative thereof, or any combination thereof. In some embodiments, the dietary supplement formula can provide up to about 60% of the Recommended Dietary Allowance (RDA) of any of the foregoing B vitamins in a single unit dose serving size. For example, in some embodiments, a single unit dose serving size of the dietary supplement formula may provide up to about 1.2 mg of pyridoxine hydrochloride, up to about 3.6 pg of cyanocobalamin, and up to about 6 mg of pantothenic acid. In some embodiments, the dietary supplement formula can provide up to about 100% of the RDA of any of the foregoing B vitamins in a single unit dose serving size.

[0044] In some embodiments, niacin can be formulated in pre-mixed liquid unit dose serving sizes for convenience of the user. In an embodiment, a suitable liquid unit dose serving sizes for the dietary supplement formula can range between about 0.05 fluid ounces (1.48 mL) and about 2 fluid ounces (59.1 mL). In another embodiment, a suitable liquid unit dose serving sizes for the dietary supplement formula can range between about 0.1 fluid ounces (2.96 mL) and about 1 fluid ounces (29.6 mL), or between about 0.25 fluid ounces (7.4 mL) and about 0.5 fluid ounces (14.8 mL). In still another embodiment, a suitable liquid unit dose serving size for the dietary supplement formula can be about 0.25 fluid ounces (7.4 mL) or about 0.5 fluid ounces (14.8 mL). Depending on the type of the food carrier to which niacin is being added, it may be desirable to use smaller unit dose serving sizes in order to lessen the likelihood of changing the taste, odor or consistency of the food carrier.

[0045] In other embodiments, niacin can be pre-mixed in a bulk liquid food carrier.

In such embodiments, an appropriate amount of niacin can be determined by the overall quantity of the food carrier to which niacin is being added to and the expected volume of dietary supplement formula that is anticipated to be consumed by a user at a given time.

[0046] In some embodiments, a unit dose serving size of the dietary supplement formula may be substantially calorie-free. As used herein, the term "substantially calorie- free" refers to a unit dose serving size of the dietary supplement formula that contains about 10 calories or less, for example, 5 calories or less, or 1 calorie or less. In some embodiments, the dietary supplement formula may contain about 4 calories or less per serving, or about 3 calories or less per serving, or about 2 calories or less per serving, or about 1 calorie or less per serving.

[0047] An amount of niacin may be from about 0.001 parts by weight to about 100 parts by weight, for example, from about 0.1 parts by weight to about 10 parts by weight based on 100 parts by weight of the dietary supplement formula.

[0048] Recommended daily allowance values for various nutritional items are established by the FDA and will be known to one having ordinary skill in the art. As discussed hereinafter, in some embodiments, the present dietary supplement formula can beneficially provide a user with a significant fraction of the RDA of niacin and various other nutritional components contained therein.

[0049] The RDA of niacin is about 14 mg/day for women and about 16 mg/day for men, and the recommended maximum daily intake is about 35 mg/day to avoid skin flushing and gastrointestinal events. The present invention provides a dietary supplement formula which allows a daily dose of up to 500 mg/day without any skin flushing and gastrointestinal symptoms.

[0050] In some embodiments, the dietary supplement formula including a food carrier and niacin distributed in the food carrier can be packaged in premeasured solid unit dose serving sizes that a user can immediately utilize. In other embodiments, the dietary supplement formula can be packaged in a bulk solid food carrier that a user can use in a chosen amount. An amount of niacin in the dietary supplement formula included in the package may be from about 1 milligram to about 500 milligrams, for example, from about 50 milligrams to about 500 milligrams, for example, from about 100 milligrams to about 500 milligrams, for example, from about 200 milligrams to about 500 milligrams, for example, from about 300 milligrams to about 500 milligrams, or for example, from about 400 milligrams to about 500 milligrams. An amount of niacin in the dietary supplement formula included in the package may be from about 500 milligrams or less, about 450 milligrams or less, about 400 milligrams or less, about 350 milligrams or less, about 300 milligrams or less, about 250 milligrams or less, about 200 milligrams or less, about 150 milligrams or less, about 100 milligrams or less, about 75 milligrams or less, about 50 milligrams or less, or about 25 milligrams or less. The package may be a sealed bag, a sealed packet, a sealed bottle, a sealed cup, a sealed pouch, but is not limited thereto. The package may also be a formulation selected from as soft capsule, a hard capsule, a tablet, a granule, and the like.

[0051] In another embodiment, a method of lowering plasma triglyceride levels in a subject having elevated plasma triglyceride levels is provided. According to the method, a dietary supplement formula including a food carrier niacin distributed in the food carrier is provided, and an effective amount of the dietary supplement formula is administered to the affected subject.

[0052] In another embodiment, a method of lowering plasma low-density lipoprotein (LDL) levels in a subject having elevated plasma low-density lipoprotein levels is provided. According to the method, a dietary supplement formula including a food carrier and niacin distributed in the food carrier is provided, and an effective amount of the dietary supplement formula is administered to the affected subject. [0053] In another embodiment, a method of alleviating the fatty liver symptoms in a subject in need thereof is provided. According to the method, a dietary supplement formula including a food carrier and niacin distributed in the food carrier is provided, and an effective amount of the dietary supplement formula is administered to the affected subject.

[0054] The total cholesterol level should be below 200 milligrams per deciliter (mg/dL) with LDL cholesterol level below 100 mg/dL for anyone with a previous

cardiovascular event and below 130 mg/dL for everyone else. The high-density lipoprotein (HDL) levels should be above 45 mg/dL or between 40 mg/dL and 45 mg/dL. The triglyceride levels should be below about 175 mg/dL.

[0055] In the above methods, the providing a dietary supplement formula may be followed by contacting the dietary supplement formula with water to provide an extract of the food carrier including niacin prior to the administering to the subject an effective amount of the extract.

[0056] In the above methods, the providing a dietary supplement formula may include providing a package including a dietary supplement formula.

[0057] Also in the above methods, the providing a dietary supplement formula may include mixing niacin and the food carrier.

[0058] The present invention involves the discovery that the oral dosage of a dietary supplement formula including a food carrier and niacin distributed in the food carrier will result in lowering plasma triglyceride levels, lowering plasma LDL levels, and alleviating the fatty liver symptoms in the subject in need thereof within a short period of time. The present invention also involves the discovery that the oral dosage of a dietary supplement formula including a food carrier and niacin distributed in the food carrier will promote beneficial dietary supplement effects, such as energy enhancement, and result in high quality of life in humans and animals.

[0059] The present invention is illustrated and further described in more detail with reference to the following non-limiting examples.

EXAMPLES

[0060] The following exemplary technical schemes describe various nutrition dietary supplement products that are useful for reducing triglycerides and cholesterol and treating fatty liver symptoms and enhancing overall health. Example 1

[0061] 3.3 grams of instant coffee with 100 to 400 mg of niacin, can be prepared in situ in separate packets or pre-mixed to obtain niacin dietary supplement coffee packets. Example 2

[0062] 2 grams of powdered tea (black tea) with 100 to 400 milligrams of niacin, can be prepared in situ in separate packets or pre-mixed to obtain niacin dietary supplement tea bags.

Example 3

[0063] 500 ml bottle of water with 136 mg niacin, 1 packet of 1 gram of artificial sweeteners, can be prepared in situ in separate bottles and packets or pre-mixed to obtain niacin dietary supplement bottled water.

[0064] Typical cases of using niacin dietary supplement products are described below.

Case 1

[0065] A 51 years old male, was initially detected with severe fatty liver symptoms, and triglycerides level of 7.65 mmol/L (about 676 mg/L, reference range 0.50-1.7 mmol/L or 44-150 mg/L), total cholesterol level of 5.67 mmol/L (about 2188 mg/L, reference range 2.90-5.70 mmol/L or 1119-2200 mg/L).

[0066] After 6 months of administration of the formulated niacin dietary supplement coffee packets stated in Example 1 of the present invention, triglycerides were measured at 266 mg/L (reference range 30-180 mg/L) and total cholesterol 242 mg/L (reference range <= 199 mg/L). Liver function was improved.

Case 2

[0067] In the embodiment of the invention described in Example 2, triglycerides were measured at 266 mg/L (reference range 30-180 mg/L) and total cholesterol 242 mg/L

(reference range <= 199 mg/L).

[0068] After 12 months of administration of the formulated niacin dietary supplement tea packets stated in Example 2 of the present invention, the detected triglyceride level was 175 mg/L (reference range 30-180 mg/L), total cholesterol level was 211 mg/L (reference range <= 199 mg/L). Liver function returned to normal, and hepatomegaly disappeared.

Case 3

[0069] In the embodiment of the invention described in Example 3, after one month of administration of the formulated niacin dietary supplement bottled water described in Example 3 of the present invention, physical strength completely restored. The following cases are in the embodiment of the invention described in Example 2.

Case 4

[0070] Male, age 53, test results:

Triglycerides 2.42 mmol/L (reference range 0.50-1.7 mmol/L),

Total cholesterol 4.68 mmol/L (reference interval 2.90-5.70 mmol/L),

Glucose (blood sugar) 6.32 mmol/L (reference interval 3.90-6.10 mmol/L), Low-density lipoprotein cholesterol 2.41 mmol/L (reference range is 1.25-4.25 mmol/L).

[0071] After 45 minutes of taking the formulation described in Example 2 of the present invention, testing:

Triglycerides 2.15 mmol/L (reference range 0.50-1.7 mmol/L),

Total cholesterol 4.66 mmol/L (reference interval 2.90-5.70 mmol/L),

Glucose (blood sugar) 6.08 mmol/L (reference interval 3.90-6.10 mmol/L), Low-density lipoprotein cholesterol 2.38 mmol/L (reference range is 1.25-4.25 mmol/L).

Case 5

[0072] Male, age 53, test results:

Triglycerides 2.06 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 4.82 mmol/L (reference interval 2.12-6.24 mmol/L),

Glucose (blood sugar) 4.36 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 2.0 mmol/L (reference range 0-3.5 mmol/L).

[0073] After 30 minutes of taking the formulation described in Example 2 of the present invention, testing:

Triglycerides 2.08 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 4.69 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 4.93 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 2.0 mmol/L (reference range 0-3.5 mmol/L).

Case 6

[0074] Male, age 53, test results:

Triglycerides 2.08 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 4.69 mmol/L (reference range 2.12-6.24 mmol/L), Glucose (blood sugar) 4.93 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 2.0mmol/L (reference range 0-3.5 mmol/L).

[0075] After 2 days of taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 1.16 mmol/L (reference range 0.50-1.70 mmol/L),

Total cholesterol 4.53 mmol/L (reference interval 2.90-5.70 mmol/L),

Glucose (blood sugar) 6.79 mmol/L (reference interval 3.90-6.10 mmol/L), Low-density lipoprotein cholesterol 2.55mmol/L (reference range is 1.25-4.25 mmol/L).

Case 7

[0076] Male, age 53, test results:

Triglycerides 1.16 mmol/L (reference range 0.50-1.70 mmol/L),

Total cholesterol 4.53 mmol/L (reference interval 2.90-5.70 mmol/L),

Glucose (blood sugar) 6.79 mmol/L (reference interval 3.90-6.10 mmol/L), Low-density lipoprotein cholesterol 2.55 mmol/L (reference range is 1.25-4.25 mmol/L).

[0077] After 2 days of taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 1.10 mmol/L (reference range 0.50-1.70 mmol/L),

Total cholesterol 4.69 mmol/L (reference interval 2.90-5.70 mmol/L),

Glucose (blood sugar) 5.21 mmol/L (reference interval 3.90-6.10 mmol/L), Low-density lipoprotein cholesterol 2.47 mmol/L (reference range is 1.25-4.25 mmol/L).

Case 8

[0078] Male, age 50, test results:

Triglycerides 3.11 mmol/L (reference range 0.48-1.82 mmol/L),

Total cholesterol 4.68 mmol/L (reference range 3.1-5.7 mmol/L),

Glucose (blood sugar) 4.8 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 2.17 mmol/L (reference range 0-4.11 mmol/L).

[0079] Two weeks after taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 1.09 mmol/L (reference range 0.50-1.7 mmol/L), Total cholesterol 4.10 mmol/L (reference interval 2.90-5.70 mmol/L), Glucose (blood sugar) 4.6 mmol/L (reference range 3.90-6.10 mmol/L), Low-density lipoprotein cholesterol 2.00 mmol/L (reference range 0-4.11 mmol/L).

Case 9

[0080] Male, age 43 years, test results:

Triglycerides 15.09 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 7.66 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 10.98 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 0.6 mmol/L (reference range 0-3.5 mmol/L).

[0081] After 30 minutes of taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 12.95 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 6.96 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 11.60 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 0.2 mmol/L (reference range 0-3.5 mmol/L).

Case 10

[0082] Male, age 53, test results:

Triglycerides 5.25 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 4.88 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 9.45 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 1.2 mmol/L (reference range 0-3.5 mmol/L).

[0083] After 30 minutes of taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 5.19 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 4.62 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 8.93 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 1.1 mmol/L (reference range 0-3.5 mmol/L).

Case 11

[0084] Male, age 53, test results: Triglycerides 7.54 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 4.87 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 11.32 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 0.7 mmol/L (reference range 0-3.5 mmol/L).

[0085] After 30 minutes of taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 5.90 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 4.40 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 11.25 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 0.7 mmol/L (reference range 0-3.5 mmol/L).

Case 12

[0086] Male, age 53, test results:

Triglycerides 6.77 mmol/L (reference range is 0-1.7 mmol/L),

Total cholesterol 6.25 mmol/L (reference range 0-5.72 mmol/L),

Glucose (blood sugar) 11.20 mmol/L (reference range 3.9-6.1 mmol/L), Low-density lipoprotein cholesterol 2.66 mmol/L (reference range 0-3.64 mmol/L).

[0087] After 30 minutes of taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 3.95 mmol/L (reference range is 0-1.7 mmol/L),

Total cholesterol 5.58 mmol/L (reference range 0-5.72 mmol/L),

Glucose (blood sugar) 10.97 mmol/L (reference range 3.9-6.1 mmol/L), Low density lipoprotein cholesterol 2.00 mmol/L (reference range 0-3.64 mmol/L).

Case 13

[0088] Female, age 55, test results:

Triglycerides 2.47 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 6.16 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 11.95 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 3.3mmol/L (reference range 0-3.5 mmol/L). [0089] After 30 minutes of taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 2.58 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 5.96 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 11.46 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 3.0 mmol/L (reference range 0-3.5 mmol/L).

Case 14

[0090] Male, Age 38, Test Results:

Triglycerides 1.91 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 5.05 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 12.78 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 2.5mmol/L (reference range 0-3.5 mmol/L).

[0091] After 30 minutes of taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 1.90 mmol/L (reference range 0.4-2.3 mmol/L),

Total cholesterol 4.97 mmol/L (reference range 2.12-6.24 mmol/L),

Glucose (blood sugar) 12.74 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 2.4mmol/L (reference range 0-3.5 mmol/L).

Case 15

[0092] Male, age 53, test results:

Triglycerides 1.04 mmol/L (reference range 0.55-1.70 mmol/L),

Total cholesterol 5.45 mmol/L (reference interval 3.00-5.18 mmol/L), Low-density lipoprotein cholesterol 3.73 mmol/L (reference interval 1.50-3.37 mmol/L).

[0093] 6 days after taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 0.92 mmol/L (reference range 0.55-1.70 mmol/L),

Total cholesterol 4.96 mmol/L (reference interval 3.00-5.18 mmol/L),

Low density lipoprotein cholesterol 3.29 mmol/L (reference interval 1.50-3.37 mmol/L). Case 16

[0094] Male, age 52, test results:

Triglycerides 2.08 mmol/L (reference range 0-2.3 mmol/L),

Total cholesterol 5.60 mmol/L (reference range 0-5.17 mmol/L),

Glucose (blood sugar) 5.24 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 3.40 mmol/L (reference range 0-3.37 mmol/L).

[0095] After 14 days of taking the formulation described in Example 1 of the present invention, testing:

Triglycerides 1.80 mmol/L (reference range 0-2.3mmol/L),

Total cholesterol 4.81 mmol/L (reference range 0-5.17 mmol/L),

Glucose (blood sugar) 5.24 mmol/L (reference interval 3.89-6.11 mmol/L), Low-density lipoprotein cholesterol 3.02mmol/L (reference range 0-3.37 mmol/L).

[0096] The present inventive concept has been described in terms of exemplary principles and embodiments, but those skilled in the art will recognize that variations may be made and equivalents substituted for what is described without departing from the scope and spirit of the disclosure as defined by the following claims.