FOOD PRODUCTS CONTAINING

HIGH DOSAGES OF BETA-GLUCAN AND OMEGA-3 FATTY ACIDS

CROSS-REFERENCE TO RELATED APPLICATION This application is based on U.S. Provisional application number 61/495,580, filed in the U.S. Patent and Trademark Office on June 10, 2011, the entire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

This disclosure relates to food supplements and, in particular, to food supplements containing high dosages of omega-3 fatty acids, specifically, EPA/DHA omega-3 fatty acids. 2. Discussion of the Related Art

The human body is capable of producing most of the saturated fatty acids that it requires. Certain polyunsaturated, omega-3 fatty acids, however, cannot be synthesized and must be supplied through diet. For this reason, these fatty acids are referred to as essential fatty acids. Only breast milk and certain sea foods, including fish oil, provide all essential fatty acids, and have the advantage of directly offering a consumer eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), thereby bypassing the often inefficient biochemical synthesis of these compounds from alpha linolenic acid (ALA), which is typically found in vegetable sources. Research has shown that these fatty acids, which are referred to herein collectively as "EPA/DHA," reduce the risk of heart disease by lowering chronic inflammation and reducing high triglycerides when consumed in high enough doses, have a positive effect on children's development when taken at sufficient amounts, and are instrumental in a variety of gene expressions.

Results have also been published indicating that these fatty acids have a positive effect on certain mental illnesses, autoimmune diseases, joint complaints, weight control/fat metabolism, and visual accuity. For example, the American Heart Association recommends that people with heart disease or diabetes consume lOOOmg EPA/DHA per day, while the average consumption in the US is 20% of this amount. Since the primary source of EPA/DHA comes from fish and fish consumption is at an historic low rate, there are many reasons for taking dietary supplements such as fish oil, which contain omega-3 EPA/DHA fatty acid sources.

Research has also shown that diets high in beta-glucans, available from, e.g. , consumption of oats and barley, may have equally positive health effects, such as a reduction in blood cholesterol levels, triglyceride/triacylglycerol levels, and blood glucose levels. The FDA has allowed food manufacturers to claim that a food serving containing at least 750mg beta glucans, may reduce the risk of heart disease. However, the typical western diet also lacks sufficient amounts of the types of grains that would supply this health-benefiting water soluble fiber to consumers. For example, it is estimated that the average American consumes less than 50% of recommended fiber amounts. High amounts of beta glucans added to foods typically become unpleasantly dry or viscous and can have an unpleasant taste.

Preparing food products that have high amounts of long-chained omega-3 fatty acids EPA/DHA has been difficult, compared to the shorter-chained vegetable version called alpha-linolic acid (ALA). For example, many people consider the taste and texture of the oils that contain these acids to be unpleasant. Furthermore, oils high in omega-3 fatty acid EPA/DHA are very susceptible to oxidation, which results in reduced health benefits and increased unpleasant odor and taste. Because the long-chained omega-3 fatty acids EPA/DHA are liquid at even freezing temperatures (in contrast with other fats), they will separate out of other food ingredients when added in high amounts and/or easily oxidize, such that most products contain amounts that are far below the required health-benefiting dose of at least 750 mg EPA/DHA per day.

SUMMARY

There remains a need for food products that contain high amounts (e.g. , 500-

4000 mg) of omega-3 fatty acid(s) EPA/DHA and at least 750mg beta-glucans per serving, as well as a manufacturing process for producing such food products, not only because of the dose, but also because these components complement each other health wise: typical fish oils only lower triglycerides and do not affect cholesterol levels, while beta-glucans lower total and LDL cholesterols and blood sugar.

Accordingly, provided herein is a composition comprising an edible food product with high dose and clinically potent omega-3 fatty acids (e.g., EPA/DHA) and beta- glucans (e.g., a dispersion comprising fish oil and oat or barley fiber) per serving. This composition, which can be in the form of a paste, is advantageous because it has a high omega-3 fatty acid content, which in some embodiments is about 500mg-4000mg EPA/DHA, and, in some particular embodiments is 750-4000 mg per serving (e.g. , 15- 150g total weight of food product). The paste also has high amounts of health-benefiting beta-glucans, which in some embodiments is, for example, 750- 1500mg per serving. The food products are also free from the unpleasant taste and odor often associated with omega-3 fatty acids such as EPA/DHA. Furthermore, these products have a high dietary fiber content and a low glycemic index, and can serve as a vehicle for other beneficial vitamins, minerals, nutrients and therapeutics. Once the composition is formed, it can be mixed with other ingredients like chocolate, yogurt, fruit puree or vegetable puree, to form a vegetable sauce, fruit sauce, whipped cream, chantilly cream, dessert mousse, vegetable mousse, meat mousse, fish mousse, meringue, pudding, or milk-based drink. The products can have a variety of flavors, and serve as a vehicle for the delivery of minerals, vitamins, supplements or medications.

Accordingly, in one aspect, provided herein is a food product comprising an omega-3 fatty acid and a beta-glucan, wherein the food product comprises 750-4000mg of total omega-3 fatty acid EPA/DHA and 750- 1500mg beta-glucanfor every 15- 150g of food product.

In one aspect, the food product comprises an omega-3 fatty acid, a beta-glucan, and yogurt, wherein the food product comprises 500-4000mg of total omega-3 fatty acid for every 15-150g of food product. In another aspect, the food product comprises an omega-3 fatty acid such as EPA/DHA, a beta-glucan, and chocolate, wherein the food product comprises 500-4000mg of total omega-3 fatty acid such as EPA/DHA and 750- 1500mg beta-glucan for every 15-150g of food product. In still another aspect, the food product comprises an omega-3 fatty acid, a beta-glucan, and a fruit or vegetable puree, wherein the food product comprises 750-4000mg of total omega-3 fatty acid such as EPA/DHA and 750- 1500mg beta glucan for every 15-150g of food product.

Any of the food products can have a total omega-3 fatty acid such as EPA/DHA of 600-3750mg, 700-2750mg, 800-1750mg, or 900-1200mg. The total food product can have a weight of 15-150g, 40-140g, 50- 130g, 60-120g, 70- 1 lOg, or 80- 100g.

The omega-3 fatty acid source can be a sea weed/algae, fish oil or vegetable oil with added EPA/DHA or fish oil. Examples of fish oil include cod liver oil, fish body oil, krill derived oil, anchovy oil, calamari oil, shark liver oil or seal oil. In one embodiment, the fish oil or vegetable oil contains at least 8 , by weight, omega-3 fatty acid EPA/DHA. In one embodiment, the fish oil or vegetable oil contains EPA and/or DHA.

For any of these food products, the beta-glucan source is baker' s yeast

(Saccharomyces cerevisiae), oats, barley, rye or wheat, bacteria strains or grains.

The chocolate can be non alkalized dark chocolate. The food product can also be in the form of a mousse. In another embodiment, the food product is in the form of a paste or mousse, and the paste or mousse is encapsulated within a hard chocolate or hard candy shell. This encapsulated paste or mousse can comprise an omega-3 fatty acid (e.g., EPA and/or DHA), a beta-glucan, chocolate, and yogurt.

The food product can also be in the form of a fruit puree, and the fruit puree can comprise apricot, pineapple, lemon, orange, peach, pear, lime, banana, grape, mango, apple, tomato, blackberry, plum, watermelon, blueberry, raspberry, strawberry, current, cherry, pomegranate, azai or cranberry, and/or mixtures thereof. The food product can also be in the form of a vegetable puree, and the vegetable puree can comprise carrots, celery, tomato, peas, beets, pumpkin, squash or carrot, and/or mixtures thereof.

The food product can also have added green tea.

In another aspect, provided herein is a food product comprising fish oil, oats or oat fiber, and yogurt, wherein the food product comprises 500-4000mg of total omega-3 fatty acid such as EPA/DHA and 750-1500mg of beta-glucan for every 15-150g of food product. In another aspect, provided herein is a food product comprising fish oil, oats or oat fiber, and a fruit or vegetable puree, wherein the food product comprises 500- 4000mg of total omega-3 fatty acid such as EPA/DHA for every 15-150g of food product. In another aspect, provided herein is food product comprising fish oil, oats or oats fiber, and chocolate, wherein the food product comprises 500-4000mg of total omega-3 fatty acid EPA/DHA for every 15-150g of food product. This food product can be in the form of a mousse. The chocolate can be dark chocolate.

Any of the food products described herein can include additional ingredients, such as milk, sugar, sugar alcohols, green tea, ginseng or vanilla extract. The food product can also include egg yolk, egg lecithin, soy lecithin, phospholipids, mono- glycerides, or di-glycerides. The yogurt can further comprise probiotics. The food products described herein can be in the form of paste, whipped cream, chantilly cream, dessert mousse, vegetable mousse, meat mousse, fish mousse, meringue, pudding, or milk-based drink.

The food products can further include a water-soluble or oil- soluble medicament or diet supplement. In one embodiment, the water-soluble or oil-soluble medicament is selected from the group consisting of cholesterol lowering drugs, antihypertensive drugs, anti-inflammation drugs, pain killers, hormones, antibiotics, antidepressants,

antiepileptics, neuroleptics, neurostimulants, libido stimulant drugs, erectile dysfunction drugs, chemotherapy agents, diabetes medication, HIV medication, hair loss medication, weight loss medications, omega-6 derivatives, omega-9 derivatives, antioxidants, vitamins, and minerals. The mineral can be calcium and/or magnesium.

In another embodiment, the food product provided herein has no perceptible fish odor or taste. In another embodiment, the fish oil described herein is non-encapsulated. In another embodiment, the food product provided herein is not produced through or exposed to the process of baking or heating, or is not a baked product.

In another embodiment, the food product is stored in freezer or refrigerator and eaten cold as ice cream.

In another aspect, provided here is a method of producing a homogenous food product having a high omega-3 fatty acid such as EPA/DHA and/or beta-glucan content, and capable of being prepared without substantial separation of the omega-3 fatty acid, comprising: combining oats or oat fiber, yogurt, and an oil containing an omega-3 fatty acid to form a homogenous mixture that is an edible food product. In an embodiment, the method further comprises combining the oats or oat fiber, yogurt and oil with cocoa or cocoa butter. The method can further comprise combining the oats or oat fiber, yogurt and oil with milk, sugar, sugar alcohols, vanilla extract, egg yolk, egg lecithin, soy lecithin, phosphor-lipids, mono-glycerides, or di-glycerides.

In some embodiments of the method, the omega-3 fatty acid source is a sea grass/algae, fish oil, or vegetable oil with added EPA/DHA. The fish oil can be cod liver oil, fish body oil, krill derived oil, calamari oil, anchovy oil, shark liver oil or seal oil. The prepared food product can be in the form of paste, whipped cream, chantilly cream, dessert mousse, vegetable mousse, meat mousse, fish mousse, meringue, pudding, or milk-based drink or the above encapsuled by a harder outer coating (shell) made with chocolate or candy style coating. In one embodiment, the method does not involve baking or heating.

In one embodiment of the food products described herein having an omega-3 fatty acid, a beta-glucan, and chocolate, the food product can further comprise yogurt.

In one embodiment of the food products described herein having an omega-3 fatty acid, the omega-3 fatty acid is EPA, DHA, or a combination thereof.

DETAILED DESCRIPTION

The lack of health-benefiting vitamins and nutrients such as essential fatty acids EPA/DHA and soluble dietary fiber in the typical western diet has led to a number of health problems, including obesity, chronic inflammation, heart diseases and mental diseases. Moreover, it is estimated that Americans have only half the amount of omega- 3 in their cells compared to the Japanese, who, on average, have the greatest life-spans in the world. In addition, the high EPA/DHA intake in the Japanese culture may explain the low rate of arteriosclerosis in Japan. It is virtually impossible for Americans to reach omega-3 levels found in Japanese societies with a diet of fish alone, because most people are discouraged from ingesting large amounts of fatty fish due to a risk of heavy metal contamination. Thus, there are many reasons for taking dietary supplements containing purified omega-3 fatty acid sources, such as fish oil, to increase levels of EPA/DHA in the cell. However, many people consider the taste or after taste of these oils to be unpleasant, and will resist taking them or using them in adequate amounts, despite strong recommendation from health authorities.

Research has also shown that diets high in beta-glucans, available from, e.g., consumption of oats and barley, may have equally positive health effects. Consumption of this nutrient can be beneficial for overall cardiovascular health, leading to decreases in cholesterol, triglyceride, and blood glucose levels. See, e.g., Queenan et al.

Concentrated oat beta-glucan, a fermentable fiber, lowers serum cholesterol in hypercholesterolemic adults in a randomized controlled trial. Nutrition Journal 2007, 6:6. h ttp ://w ww . n utritionj .com/content/6/ 1 /6. It is estimated that most Westerners only ingest a fraction of the recommended daily amount of these types of fibers, which may be due to increased consumption of highly processed foods that contain limited amounts of fiber. Research indicates that low glycemic (a value relating to how fast and how high a post prandial glucose response will be) foods containing fibers and carbohydrates from whole grains and certain vegetables and fruits may increase satiety (and thereby weight control) and mental focus, and facilitate blood sugar control in subjects with metabolic disorders, such as diabetics or pre-diabetics. See, e.g., Nutrition Reviews Vol. 67(4): 188-205.

Also, dietary fibers and omega-3 fatty acids have many of the same health benefits, but are effective through different modes of action, which opens the possibilities of synergistic and augmented health effects when these nutrients are combined.

While food products containing omega-3 fatty acids and oats are currently available to the public, a typical serving size of these products generally provides meager amounts of EPA or DHA and beta-glucans, which are far lower than the combined high dosages provided by the present invention, described herein in detail. For example, Boundless Nutrition produces a Wellness Bar that contains oats and fish oil, but one bar (serving size of 50g) provides 300mg of EPA and DHA, which is only a fraction of the recommended daily dose of this essential fatty acid. Similarly, the Bellybar by NutraBella and SmartNourish fruit sauces by Gerber contain only limited amounts of DHA. Moreover, omega-3 fatty acids are typically in micro-encapsulated form to prevent their separation during production of the food product. In contrast, through the use of a composition comprising omega-3 fatty acids and beta-glucans (e.g., a composition comprising fish oil and oats), provided herein are food products, and methods of making food products, that have a high omega-3 fatty acid EPA/DHA content of about 500mg-4000mg, e.g., 750-4000 mg, of omega-3 fatty acid and 750-

1500mg beta glucan per serving, where a serving is, for example, 15-150g total weight of food product.

Definitions

The term "serving" or "serving size" as used herein refers to FDA regulation 21

CFR 101.9(b) and 21 CFR 101.12 (herein incorporated by reference). The serving size typically appears on food labels and is based on FDA-established lists of "Reference Amounts Customarily Consumed Per Eating Occasion," which in most cases reflect the food quantities set forth in 21 CFR 101.12. Examples of serving sizes of the food products of the invention include, but are not limited to, approximately 5g - 150g, e.g., 7g - 120g, e.g., lOg - 90g, e.g., 20g - 80g, e.g., 30g - 70g, e.g., 40g - 65g, e.g., about 45- 60g. In one embodiment, the serving size is approximately 40-100g, e.g., approximately 40g, 50g, 60g, or 70g. As used herein, "serving" or "serving size" can include just the composition comprising an omega-3 fatty acid (e.g. , fish oil) and a beta-glucan (e.g. , oats), or a total food product that comprises, e.g. , an omega-3 fatty acid (e.g. , fish oil), a beta-glucan (e.g. , oats), and one or more additional ingredients.

According to some embodiments, the omega-3 fatty acid / beta-glucan composition can be further mixed with a yogurt. As described herein, the term "yogurt" includes, but is not limited to, all of those food products meeting the definition as set forth in 21 C.F.R. Section 131.200, 131.203, and 131.206. Advantageously, the yogurt can also include probiotics.

The term "probiotics" is in general defined to be "living microorganisms capable of improving the balance of the enterobacterial flora in a host to thus bring beneficial effects on the host" (Fuller R.: Gut, 1991, 32:439-42). In addition, it has been reported that the probiotics typically represented by lactic acid bacteria possess a wide variety of functions (Sanders M E & Huis in't Veld J: Antonie van Leeuwenhoek, 1999, 76: 293- 315): 1) Assistance of lactose-digestion; 2) resistance to enterobacteria; 3) inhibition of the occurrence of colon cancer; 4) inhibition of small intestinal bacteria-excess proliferation; 5) immuno-modulating effects; 6) anti-allergic effects; 7) effects of reducing blood lipid concentration; 8) hypotensive effects; 9) inhibition of urinary tract- infection; 10) inhibition of Helicobacter pylori infection; and 11) inhibition of hepatic encephalopathy.

According to some embodiments, the omega-3 fatty acid / beta-glucan composition can be further mixed with a fruit or vegetable puree. As used herein, the term "puree" refers to both heat treated, e.g. , boiled, and untreated food pulp. The term "puree" also refers to whole fruit or vegetable pieces which have been mechanically transformed into fluids. Puree preparation does not require that all fruit or vegetable material be macerated, and the fruit or vegetable puree can include discreet fruit chunks or bits as convenient. Puree is also referred to as "truffle" when encased in a harder outer shell made of chocolate or sugar coating.

According to some embodiments, purees made from any fruit or vegetable can be used herein. Examples of such fruits include apricot, pineapple, lemon, orange, peach, pear, lime, banana, grape, mango, apple, tomato, blackberry, plum, watermelon, blueberry, raspberry, strawberry, current, cherry, cranberry, pomegranate or azai, and mixtures thereof. However, previously frozen fruit is also suitable for use herein. Examples of vegetables that can be used to make purees include carrots, celery, tomato, peas, beets, pumpkin, squash or carrot, and mixtures thereof.

According to some embodiments, the omega-3 fatty acid / beta-glucan composition can be combined with additional ingredients, such as chocolate, to form a mousse. The term "mousse" as used herein applies to a variety of light dessert creams. Mousses can be made either sweet or savory, depending on the ingredients. The mousse can have green tea or ginseng added. Usually, dessert mousses are of the sweet variety. Depending on how it is prepared, a mousse can range from light and fluffy to creamy and thick. It can be light and airy due to, for example, the addition of whipped egg whites, whipped cream or both, in some cases. It can also contain some form of gelatin or gum. The term "mousse" also can refer to "truffle" when encased in a harder outer shell.

Suitable chocolate may be obtained using any of the various processes known in the art as described in, for example, The Science of Chocolate, by Stephen T. Beckett, The Royal Society of London (2000), incorporated by reference in its entirety. The term "chocolate" includes, without limitation, sweet chocolate, semi-sweet chocolate, dark chocolate, milk chocolate, white chocolate, couverture chocolate, baking chocolate, and any of those for which a standard of identity has been established by the U.S. Food and Drug Administration under 21 C.F.R Section 163, Subpart B. "Dark chocolate" generally refers to sweet, semisweet or bittersweet chocolate. "Sweet" chocolate contains not less than 15% chocolate liquor and less than 12% by weight of total milk solids. Semisweet chocolate or bittersweet chocolate contains not less than 35% by weight of chocolate liquor. "Sweet", "semisweet", "bittersweet", "bitter", "baking", "cooking", and "unsweetened" chocolate and contains not less than 15% (if "sweet") and not less than 35% (if "semisweet" or "bittersweet") by weight of chocolate liquor.

Lecithin and other emulsifiers are generally also used in chocolates. Vanilla or vanillin and salt are often added to increase chocolate flavor intensity. Of course, it is within the scope of the invention to include other food components commonly found in chocolate confections, such as nut meats, nut butters, puffed grains, fruit, soy, caramel, and the like. Suitable chocolate may be obtained using any of the various processes known in the art.

According to some embodiments, the omega-3 fatty acid / beta-glucan composition (with or without additional ingredients) can be in the form of a paste. The term "paste" as used herein refers to a material in a state between liquid and solid, which may be described as semi-liquid or semi-solid. These two descriptions, semi-liquid and semi-solid, are synonymous.

According to some embodiments, the omega-3 fatty acid / beta-glucan composition (with or without additional ingredients) can be in the form of a dispersion. The term "dispersion" as used herein refers to the mixture of a dispersible substance (e.g. , an ingredient containing a beta-glucan) and a carrier (e.g. , an oil containing an omega-3 fatty acid). In the context of the invention, an ingredient containing a beta- glucan, such as oats or oat fiber, is dispersible in an oil containing an omega-3 fatty acid, such as fish oil. The term "dispersible" is intended to include the term "soluble." A dispersion can also include an aqueous suspension or an aqueous emulsion.

The term "recommended daily dose" refers to the amount of recommended servings of a nutritional supplement (e.g. , an omega-3 fatty acid, e.g. , EPA, DPA, DHA and/or ALA).

The term "bite- sized" refers to a food product of a size that can be eaten in one bite, e.g. , 15-20 g.

The omega-3 fatty acid / beta-glucan composition (with or without additional ingredients) can be referred to as a manufactured food product. The term "manufactured food product" as used herein refers to a food product produced by combining two or more components, such that the food product does not exist in nature. Accordingly, manufactured food products of the present invention have undergone processing (e.g. , mixing, kneading, stirring, whisking, cutting, chopping, mincing, pounding, pulverizing, macerating, milling, grinding, and/or, cooking, etc.).

The term "subject" refers to mammalian subjects, e.g. , humans, dogs, cows, horses, pigs, sheep, goats, cats, mice, rabbits, and rats, that are capable of benefiting from omega-3 fatty acids and/or beta-glucans.

The terms "treat," "treated," "treating" or "treatment" include the diminishment or alleviation of at least one symptom of a disease upon consuming the omega-3 fatty acid/beta-glucan-containing food product of the invention. Treatment can be

diminishment of one or several symptoms of a disorder or complete cure of a disorder.

The term "prevent" or "prevention" refers to reducing or abolishing the risk that some undesired health condition or disease may occur. The term "combining" refers to the process whereby compounds are brought into a close relationship to result in a mixture in which each individual ingredient is present. Combining of ingredients (e.g., an oil containing an omega-3 fatty acid, and oats) can be done with any suitable mixing technique, including stirring, whisking, pounding, pulverizing, macerating, milling, grinding, tumbling, etc.

Food Products Containing Omega-3 Fatty Acids and Beta-Glucans

In some embodiments, the invention provides a method of producing a food product having an omega-3 fatty acid and beta-glucan content, comprising combining a beta-glucan source (baker's yeast (Saccharomyces cerevisiae), oats, barley, rye or wheat) with an oil containing an omega-3 fatty acid to form a homogenous viscous mixture. Once the viscous mixture is prepared, it can be combined with other ingredients, such as chocolate, yogurt, a fruit puree or vegetable puree to form a paste, whipped cream, chantilly cream, dessert mousse, vegetable mousse, meat mousse, fish mousse, meringue, pudding, or milk-based drink. The method of the present invention is advantageous because it produces a food product that is homogenous, and contains high dosages of omega-3 fatty acids (EPA/DHA) and beta glucans, without substantial separation of the omega-3 fatty acid from the food product, as well as little or no unpleasant taste associated with high dosages of omega-3 fatty acids per each serving unit. In a particular embodiment, the methods of the invention produce a food product that has a high omega-3 fatty acid content of at least about the recommended daily dose of 750mg - 4000mg of omega-3 fatty acids EPA/DHA and 750-1500mg beta glucan. (See, e.g., Covington, American Family Physician, Vol. 70, No. 1, pp. 133- 140, which is incorporated herein by reference in its entirety). The high omega-3 fatty acid content can be supplied by EPA, DHA or a combination thereof.

According to some embodiments, the omega-3 fatty acid component can be any fatty acid that includes a double bond at the third carbon from the omega position of the fatty acid. Omega-3 fatty acids suitable for the invention include EPA, DHA, docosapentaenoic acid (DPA), EDA, and/or alpha linolenic acid (ALA). The food product of the invention can contain one or more of these omega-3 fatty acids, e.g., EPA and DHA, in a variety of different ratios. For example, the omega-3 fatty acid component of the food product can include a ratio of EPA to DHA of about 1:6-6: 1 ; or 10: 1, 5: 1, 2: 1, 1: 1, 1:2, 1:5 or 1: 10; or 1: 1-2:3 by volume, per serving of food product. In a particular embodiment, the omega-3 fatty acid is not encapsulated. In one embodiment of the method, the oil comprises approximately 5-20 %, e.g. , 10-20%, by weight, of the total solid food product. As used herein, the term "omega-3 fatty acid" can refer to either the omega-3 fatty acid itself (EPA, DHA, etc.), or, as described below, an omega- 3 fatty acid source (e.g. , fish oil).

Any suitable source of omega-3 fatty acid can be used in the invention, including, but not limited to, vegetable oils with added EPA/DHA, marine oils such as fish oils and fish liver oils, and algae. Possible vegetable oil sources include olive oil, soybean oil, canola oil, high oleic sunflower seed oil, high oleic safflower oil, safflower oil, sunflower seed oil, flaxseed (linseed) oil, corn oil, cottonseed oil, peanut oil, evening primrose oil, borage oil, and blackcurrant oil. Suitable fish oils include cod liver oil, fish body oil, or krill derived oil. Other sources include salmon oil, cod oil, herring oil, mackerel oil, anchovy oil, anchovies, sardine oil, menhaden oil or shark liver oil. In one embodiment, the method of the invention uses an oil that contains at least 10 %, e.g. , at least 30 %, omega-3 fatty acid. In a particular embodiment, the omega-3 fatty acid source is not encapsulated.

The beta-glucan component can be a polysaccharide of D-glucose monomers linked by beta-glycodidic bonds. Beta-glucans are a diverse group of molecules that can vary with respect to molecular mass, solubility, viscosity, and three-dimensional configuration. As used herein, a beta-glucan can be an insoluble (1,3/1,6) beta-glucan, a soluble (1,3/1,4) beta-glucan, or a combination of both.

According to some embodiments, the beta-glucan / omega-3 fatty acid composition can be made using extracted beta-glucan. In addition, any cereal grain with a beta-glucan component therein may be used to make the beta-glucan / omega-3 fatty acid composition described herein. Such cereal grains include, but are not limited to, baker' s yeast (Saccharomyces cerevisiae), barley, oats, wheat, rice, rye, corn, sorghum and millet. According to some embodiments, oats and barley are preferred because of their higher levels of naturally occurring beta-glucan. For example, oat grain has a 4% by weight beta-glucan content while barley grain has a 5-7% by weight beta-glucan content.

According to some embodiments, the methods of the invention further include the use of a beta-glucan source, such as oats or barley, which, when mixed with the omega-3 fatty acid source (e.g. , fish oil), assists in suppressing the smell and/or taste of the oil in the food product by "reacting" with the oil, creating high-viscosity paste and helping to reduce the separation of the otherwise liquid omega 3 from the other ingredients. By suppressing the smell and/or taste of the omega-3 fatty acid, or the omega-3 fatty acid source (e.g. , fish oil), one can load a higher concentration of the omega-3 fatty acid into a single serving of a food product without the consumer of the food product detecting the presence (i.e., smell, taste and/or visible fat granules) of the omega-3 fatty acid in the food product.

To further stabilize the paste and prevent the high content of omega 3 EPA/DHA to separate and oxidize, it is preferable to keep and store the food in the freezer or refrigerator. Since high-concentration omega 3 EPA/DHA makes the food product soft and flexible, even at cold temperatures, the food can be eaten as ice cream right out of the freezer. To further protect the integrity of the fish oil in the paste, the paste can be enrobed with an outer chocolate or candy shell that will form an additional barrier to oxidation.

Furthermore, by combining the omega-3 fatty acid with a beta-glucan, one can load a higher concentration of the omega-3 fatty acid into a single serving of a food product, without substantial separation of the omega-3 fatty acid from the food product. The food products of exemplary embodiments are also advantageous because, in addition to having a high content of omega-3 fatty acid EPA/DHA, they also serve as a good source of beta-glucans. Beta-glucans are known to have many health benefits, such as a reduction in blood cholesterol levels, triglyceride/triacylglycerol levels, and blood glucose levels.

While not wishing to be bound by theory, it is believed that that the source of the beta-glucans (oats, barley, rye, wheat, etc.) when combined with the oily omega-3 fatty acid component (e.g. , fish oil) forms a homogenous dispersion. In turn, this dispersion, when combined with an additional component, such as chocolate, yogurt, fruit puree or vegetable puree, results in a homogenous food product with an amount of omega-3 fatty acid that would not have been achieved without substantial separation of the oily omega- 3 fatty acid. The dispersion may form due to the interaction of the beta-glucans with the omega-3 fatty acids. Without wishing to be bound by theory, by binding to the omega-3 fatty acids, the beta-glucans from the oats, barley, rye, wheat, etc. interact with the omega-3 molecules and impede oxidation of the fatty acids, thereby preventing the degradation of the fatty acids in the food product in addition to holding the fat and preventing it from floating away from the other ingredients.

The dispersion of beta-glucans and omega-3 fatty acids also can be mixed with a variety of additional ingredients (described herein), including oil or water soluble therapeutic agents, and will not separate from those ingredients. As such, the dispersion, when combined with an additional ingredients like chocolate, yogurt, fruit puree or vegetable puree, results in, or, alternatively, can be used as an ingredient in, a food product that has a "high" omega-3 fatty acid EPA/DHA content, meaning it can provide a subject with a recommended daily dose of essential omega-3 fatty acids in one serving.

Mixing the omega-3 fatty acid / beta-glucan composition with chocolate can also have advantages in chocolate preservation. As discussed in J Food Sci. 2011

Jan;76(l):C142-53, inadequate chocolate storage can lead to rearrangement of triglycerides that make up the bulk of the chocolate matrix, which can result in quality loss. Storing chocolate in a mixture with the omega-3 fatty acid / beta-glucan composition can be useful for preserving the integrity of the chocolate makeup.

According to some embodiments, once the omega-3/beta-glucan-containing food product is prepared, it can be mixed (using known techniques) with additional food ingredients to improve taste or consistency. Such ingredients include, but are not limited to, milk, sugar, sugar alcohols or vanilla extract. Additional ingredients can also include an emulsifier, for example, egg yolk, egg lecithin, soy lecithin, phospholipids and mono- and di-glycerides. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalent ingredients that can be used in combination with the omega-3/beta-glucan-containing food product of the invention. According to some embodiments, other ingredients that may be included in the food product include, but are not limited to, enriched flour, white sugar, brown sugar, margarine, non- hydrogenated margarine, canola oil, non-hydrogenated canola oil, modified palm oil, palm oil, palm kernel oils, water, salt, milk, modified milk

ingredients, soya lecithin, potassium sorbate, artificial flavoring, sugar, chocolate, chocolate liquor, cocoa butter, dextrose, soy lecithin, corn syrup, eggs, sodium bicarbonate, and baking powder. According to some embodiments, alcoholic beverages, such as wine, can also be included in the food product as an ingredient.

According to some embodiments, omega-3/beta-glucan-containing food products additionally can include other oil and/or water soluble therapeutic agents. Because the food product is formed by a dispersion of an oily omega-3 fatty acid source and a beta- glucan source, the additional therapeutic agents can be water-soluble or oil-soluble, including water-soluble or oil-soluble diet supplements, green tea, ginseng or

medicaments, including, but not limited to, antioxidants, cholesterol lowering drugs, antihypertensive drugs, anti-inflammation drugs, pain killers, hormones, antidepressants, and/or weight loss medications.

According to some embodiments, omega-3/beta-glucan-containing food products also can contain minerals, such as calcium, magnesium, manganese, zinc, iron, and phosphorus; and/or vitamins such as Vitamin A, the Vitamin B group, Vitamin C, D, E and K.

According to some embodiments, omega-3/beta-glucan-containing food products can be processed using any known technique (e.g. , mixing, blending, kneading) to form an edible food containing the omega-3-containing food product. In a particular embodiment, the food product is not further processed by cooking (e.g. , heating, baking, toasting, etc.). The result is a homogenous, edible omega-3/beta-glucan-containing food product containing at least about 500mg - 4000mg of omega-3 fatty acids EPA/DHA and 750- 1500mg of beta glucan per serving, without separation (or encapsulation) of the omage-3 fatty acid or unpleasant taste or odor. In one embodiment, the edible food comprises more than about 500 mg, or about 1000-4000 mg of EPA, DHA, ALA, or DPA, individually or in some combination, per serving of foodstuff. According to some embodiments, edible food products include, but are not limited to, paste, whipped cream, chantilly cream, truffle, dessert mousse, vegetable mousse, meat mousse, fish mousse, meringue, pudding, or milk-based drink. In a particular embodiment, the edible food is a mousse.

Thus, in one aspect, provided herein is a composition comprising an omega-3 fatty acid and a beta-glucan. The composition can be further combined with yogurt to make a yogurt product that is rich in omega-3 fatty acids. Thus, provided herein is a food product comprising an omega-3 fatty acid, a beta-glucan, and yogurt, wherein the food product comprises 500-4000mg of total omega-3 fatty acid for every 15- 150g of food product. In another aspect, provided herein is a food product comprising fish oil, oats, and yogurt, wherein the food product comprises 750-4000mg of total omega-3 fatty acid EPA/DHA for every 15- 150g of food product. Advantageously, the yogurt can also include probiotics. Moderate consumption of chocolate has been shown to be useful in the prevention of cardiovascular diseases. See, e.g., J Cardiovasc Pharmacol. 2009 December; 54(6): 483-490; J Thromb Thrombolysis. 2009 Nov;28(4):482-8. Epub 2008 Sep 23; and Am J Clin Nutr 2008;88:58-63. Also, chocolate, especially dark , non alkalized chocolate, is known to have a high oxygen radical absorbance capacity (ORAC) value. The omega-3 fatty acid / beta-glucan composition can be combined with chocolate, such as dark chocolate, to form a chocolate paste or mousse that is rich in omega-3 fatty acids. Thus, provided herein is a mousse or paste comprising an omega-3 fatty acid, a beta-glucan, and chocolate, wherein the food product comprises 500-4000mg of total omega-3 EPA/DHA fatty acid and 750-1500mg of beta glucan for every 15-150g of food product. In another aspect, provided herein is a mousse or paste comprising fish oil, oats, and chocolate, wherein the food product comprises 750- 4000mg of total omega-3 fatty EPA/DHA acid and 750-1500mg of beta glucan for every 15-150g of food product.

In some embodiments, the chocolate mousse or paste that is rich in omega-3 fatty acids can be encapsulated in a chocolate or hard candy shell. Such a shell has the advantage of minimizing the amount of air to which the omega-3 fatty acid is exposed, thereby decreasing the amount of oxidation of the fatty acids. Such a shell can also protect the chocolate of the mousse or paste from air exposure, which will lead to an increased shelf life of the chocolate. In some embodiments, the chocolate mousse or paste that is covered in such a shell is produced in bite-sized pieces.

According to some embodiments, the omega-3 fatty acid / beta-glucan composition can be combined with a fruit or vegetable puree. Thus, provided herein is a food product comprising an omega-3 fatty acid, a beta-glucan, and a fruit or vegetable puree, wherein the food product comprises 500-4000mg of total omega-3 fatty acid EPA/DHA and 750-1500mg of beta glucan for every 15-150g of food product. In another aspect, provided herein is a food product comprising fish oil, oats, and applesauce, wherein the food product comprises 750-4000mg of total omega-3 fatty acid EPA/DHA and 750-1500mg of beta glucan for every 15-150g of food product.

In some embodiments, the food products described herein do not contain a fruit juice or vegetable juice. In some embodiments, the food product described herein does not contain a concentrated fruit juice or concentrated vegetable juice. In some embodiments, the food product is not in the form of a cookie. In some embodiments, the food product contains green tea or ginseng.

Methods of Treatment Using Food Products

Due to the known beneficial effects of omega-3 fatty acids, and the ability to include other nutrients or therapeutic agents, omega-3-containing food products of the invention can be used to treat or prevent a wide variety of diseases and disorders.

Accordingly, the food products of the instant invention can be used, for example, to prevent or reduce the risk of coronary heart disease, treat certain circulatory problems, such as varicose veins, stimulate blood circulation, stimulate the breakdown of fibrin, lower blood pressure, reduce blood triglyceride levels, reduce secondary and primary heart attack, treat rheumatoid arthritis, cardiac arrhythmias, depression, thrombosis and anxiety, as well as reduce the risk of ischemic and thrombotic stroke. The food products of the instant invention also can be used for the treatment of cancer or cancer prevention, such as breast, colon and prostate cancer. The food products of the invention can also be used to control the blood sugar of a subject with a metabolic disorder, e.g. , diabetes, or prevent the passage from pre-diabetic stages to full diabetes. In one embodiment, the omega-3 containing food products of the invention are used to treat autism, ADD, pre- dementia, depression, schizophrenia, epilepsy, macular degeneration, glaucoma, arthritis, weight control, weight loss, hair loss (alopecia) hypertension, dyslipidemia, diabetes, cognitive effects, Parkinson's disease, asthenia, sexual dysfunction, skin burns, infertility and HIV. In some embodiments, the omega- 3-containing food products are used to reduce triglycerides in a subject. In some embodiments, the omega- 3 -containing food products are used to reduce wrinkles in a subject. In some embodiments, the omega-3-containing food products can be used as an adjuvant to a cancer therapy.

In some embodiments, the omega-3 -containing food products can be used to improve weight control, weight loss, and cognitive functioning in a subject. In some embodiments, the omega-3-containing food products are used to reduce the plasma lipid profile of a subject.

In particular embodiments, the omega-3-containing food product contains additional therapeutic agents. Depending on the type of medicaments that are included in the food product (e.g. , cholesterol lowering drugs such as statins, antihypertensive drugs, anti-inflammation drugs, pain killers, hormones, anti-depressants, medications to treat migraine, and/or weight loss medications), the food product can be used to treat any number of diseases and disorders in a subject.

Kits

Advantageously, the present invention also provides kits (e.g. , pre-packaged mixes) for preparing the omega-3-containing food products of the invention. Omega-3 fatty acids are prone to oxidation/loss of effect by time, high temperature, light, and poor storage conditions. Thus, one advantage of such a kit is the ability to ship the pre-mixed ingredients of the invention to the consumer (e.g. , a chef), so the consumer can produce a fresh food product containing a precise and predetermined high-dose of omega-3 fatty acids and beta-glucan.

Kits of the invention comprise, at least in part, a) an oil containing an omega-3 fatty acid, and a beta-glucan source as described herein; and, optionally, b) instructions for preparing the omega-3 containing food products of the invention (e.g. , a food product, e.g. , a mousse, having a high dose of an omega-3 fatty acid). For example, the instructions can include mixing instructions, including how to blend the ingredients of the invention, how to measure the ingredients, how to further combine the beta- glucan/omega-3 fatty acid oil with additional ingredients to form an omega-3-containing food product (e.g. , a mousse), packaging procedures, and storage requirements. The kit can further include the additional food and/or nutritional ingredients described herein, including, but not limited to, green tea, ginseng, apricot, pineapple, lemon, orange, peach, pear, lime, banana, grape, mango, apple, tomato, blackberry, plum, watermelon, blueberry, raspberry, strawberry, current, cherry, cranberry, pomegranate or azai, and mixtures thereof; carrots, celery, tomato, peas, beets, pumpkin, squash or carrot, and mixtures thereof; cocoa, cocoa in the form of dark chocolate; milk, sugar alcohols, sugar, or vanilla extract; egg yolk, egg lecithin, soy lecithin, phospholipids, mono- glycerides, or di-glycerides; yogurt; as well as a water-soluble or oil-soluble diet supplement or medicament.

In some embodiments, the kit includes a container for containing the separate ingredients of the invention (e.g. , a beta-glucan source and oil containing an omega-3 fatty acid, or some combination thereof), such as a divided container. The container can be in any conventional shape or form as known in the art which is made of an acceptable material, for example, a paper or cardboard box, a glass or plastic bottle or jar, or a re- sealable bag, such as a food- grade plastic bag. Furthermore, the kit can include one or more empty food-grade plastic bags with an FDA compliant label that can be used to carry the baked food product of the invention.

Equivalents

Those skilled in the art will recognize, or be able to ascertain using no more routine experimentation, many equivalents to the specific embodiments described herein. Such equivalents are intended to be encompassed by the following claims. Incorporation by Reference

The entire contents of all patents, published patent applications, websites, and other references cited herein are hereby expressly incorporated herein in their entireties by reference. Exemplification

The invention is further illustrated by the following example. The example should not be construed as further limiting.

45-50g Serving of Chocolate Mousse

Having Beta-Glucans and High-Dose of Omega-3 Fatty Acids

8-10g fish oil

15g dark chocolate

20-25g yogurt

28 beta-glucan fiber

Store cold

Mousse can be molded into chocolate size pieces and enrobed with chocolate covering.