Dietary supplement composition

Abstract

Provided herein are dietary supplement compositions. For example, provided herein are dietary supplement compositions having beta glucan, quercetin, and one or more of vitamin A, vitamin C, vitamin D, and zinc.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 340,269, filed May 10, 2022. The disclosure of the prior application is considered part of (and incorporated by reference into) the disclosure of the present application. background 1. Technical Field

[0004] The present invention relates to the field of dietary supplements. For example, the present invention relates to dietary supplement compositions that can be used to improve the immunity of humans or other mammals.

[0005] 2. Background Information

[0006] Many people desire improved health and well-being, particularly their immune health and function. According to the CDC in 2020, two of the 10 leading causes of death in the United States are directly related to immune health and function (https: / / www.cdc.gov / nchs / fastats / deaths.htm). COVID-19 and influenza or pneumonia are the third and ninth most deadly conditions, respectively. With the exception of unintentional injuries, all other leading causes of death are indirectly attributed to poor immune health. This fact was demonstrated globally during the COVID-19 pandemic, with over 90% of deaths associated with at least one other pre-existing comorbidity, and the likelihood of death was over 1,000 times higher in those with at least one comorbidity compared to those without. Therefore, people around the world need a stronger immune system. Summary of the Invention

[0007] Provided herein are dietary supplement compositions. For example, provided herein are dietary supplement compositions that can be consumed by humans or animals. Provided herein are dietary supplement compositions that can improve immunity. Typically, provided herein are dietary supplement compositions that include beta glucan, quercetin, and one or more of vitamin A, vitamin C, vitamin D, and zinc.

[0008] Typically, the dietary supplement compositions described herein can enhance the immune function of a subject to which the composition is administered (e.g., the production and / or action of cells that fight disease or infection). In some cases, the compositions provided herein can comprise quercetin having increased bioavailability (e.g., a bioavailability greater than 1, such as a bioavailability of about 2 to about 100). In some cases, the β-glucan and quercetin in the compositions described herein can have a synergistic effect on the immune system.

[0009] In one aspect, the present invention features dietary supplement compositions that may include, consist of, or consist essentially of beta glucan, quercetin, and one or more of vitamin A, vitamin C, vitamin D, and zinc. The composition may include beta glucan in the form of beta-(1,3)-glucan. The composition may include quercetin complexed with one or more phospholipids. The composition may include quercetin in a blend comprising Sophora japonica extract and one or more phospholipids. The composition may include vitamin A. The composition may include vitamin C. The composition may include vitamin D. The composition may include zinc. The composition may include vitamin A, vitamin C, vitamin D, and zinc. The composition may include zinc in the form of amino acid chelated zinc.

[0010] In another aspect, the present disclosure features dietary supplement compositions that may include, consist of, or consist essentially of beta glucan, quercetin, vitamin D, vitamin A, vitamin C, and zinc. The composition may include beta glucan in the form of beta-(1,3)-glucan. The composition may include quercetin complexed with one or more phospholipids. The composition may include quercetin in a blend comprising Sophora japonica extract and one or more phospholipids. The composition may include zinc as a zinc-amino acid compound. The composition may include zinc as a zinc-amino acid compound conjugated to a polysaccharide. The composition may include beta glucan in an amount of about 35 mg to about 1500 mg. The composition may include quercetin in an amount of about 5 mg to about 1500 mg. The composition may include vitamin A in an amount of about 25 mcg RAE to about 1500 mcg RAE. The composition may include vitamin C in an amount of about 9 mg to about 2000 mg. The composition can include vitamin D in an amount of about 0.005 mg to about 0.1 mg. The composition can include zinc in an amount of about 1 mg to about 75 mg. The composition can include quercetin having a bioavailability of greater than 1, or from about 2 to about 100, or from about 25 to about 75, or from about 40 to about 60. The composition can include beta glucan, wherein the beta glucan is isolated from algae. In some cases, the algae is Euglena gracilis algae. The composition can be in the form of a tablet or capsule.

[0011] Also provided herein are dietary supplement compositions that may comprise, consist of, or consist essentially of, beta glucan in an amount of about 35 mg to about 1500 mg, quercetin in an amount of about 5 mg to about 1500 mg, vitamin A in an amount of about 25 mcg RAE to about 1500 mcg RAE, vitamin C in an amount of about 9 mg to about 2000 mg, vitamin D in an amount of about 0.005 mg to about 0.1 mg, and zinc in an amount of about 1 mg to about 75 mg. The composition may comprise beta glucan in an amount of about 100 mg to about 300 mg. The composition may comprise quercetin in an amount of about 5 mg to about 200 mg. The composition may comprise vitamin A in an amount of about 400 mcg RAE to about 500 mcg RAE. The composition may comprise vitamin C in an amount of about 10 mg to about 100 mg. The composition may comprise vitamin D in an amount of about 0.009 mg to about 0.05 mg. The composition may comprise zinc in an amount of about 5 mg to about 50 mg. The composition may comprise zinc in the form of amino acid chelated zinc. The composition may comprise quercetin complexed with one or more phospholipids. The composition may comprise quercetin in a blend comprising Sophora japonica extract and one or more phospholipids. The composition may comprise beta glucan in the form of beta(1,3)-glucan.

[0012] In yet another aspect, the present disclosure features a dietary supplement composition that can include at least about 35 mg of beta glucan, at least about 5 mg of quercetin, at least about 25 mcg RAE of vitamin A, at least about 9 mg of vitamin C, at least about 0.005 mg of vitamin D, and at least about 1 mg of zinc.

[0013] As used herein, the term "about," when used in reference to a weight % in a composition, means ±10% of the reported weight %. As used herein, the term "about," when used in reference to a measured property of a composition, means ±20% of the reported value.

[0014] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention belongs. Although methods and materials similar or equivalent to those described herein can be used to implement the present invention, suitable methods and materials are described below. All publications, patent applications, patents and other references mentioned herein are incorporated herein by reference in their entirety. In the event of a conflict, the present specification including definitions shall prevail. In addition, the materials, methods and examples are illustrative only and are not intended to be limiting.

[0015] The details of one or more embodiments of the invention are set forth in the description below. Other features, objects, and advantages of the invention will be apparent from the description and from the claims. DETAILED DESCRIPTION

[0016] Provided herein are dietary supplement compositions comprising beta glucan, quercetin, and one or more of vitamin A, vitamin C, vitamin D, and zinc. For example, the dietary supplement compositions provided herein can comprise beta glucan, quercetin, vitamin A, vitamin C, vitamin D, and zinc. In some cases, the dietary supplement compositions provided herein can comprise beta glucan, quercetin, and vitamin A; beta glucan, quercetin, and vitamin C; beta glucan, quercetin, and vitamin D; beta glucan, quercetin, and zinc; beta glucan, quercetin, vitamin A, and vitamin C; beta glucan, quercetin, vitamin A, and vitamin D; beta glucan, quercetin, vitamin A, and vitamin D; beta glucan, quercetin, vitamin A, and vitamin D; Vitamin A and zinc; beta glucan, quercetin, vitamin C, and vitamin D; beta glucan, quercetin, vitamin C, and zinc; beta glucan, quercetin, vitamin D, and zinc; beta glucan, quercetin, vitamin A, vitamin C, and vitamin D; beta glucan, quercetin, vitamin A, vitamin C, and zinc; beta glucan, quercetin, vitamin A, vitamin D, and zinc; or beta glucan, quercetin, vitamin C, vitamin D, and zinc.

[0017] The dietary supplement compositions provided herein include quercetin, which is a flavonoid with antioxidant properties, anti-inflammatory properties, and immune-enhancing functions. For example, quercetin can stimulate the production of helper T cells 1, helper T cells 2, and regulatory T cell cytokines, which can enhance the defensive effects of killer T cells (T-killer cells) and enhance the feedback signals (e.g., to prevent cytokine storms) that "turn off" cytokine production once pathogens are no longer present. Quercetin also has antiviral activity mediated by inhibiting viral proteases.

[0018] Quercetin has poor absorption when administered orally or by topical application, in part due to bacterial degradation of the phenolic portion of the molecule, and also due to the formation of complexes with other substances present in the gastrointestinal tract. However, when quercetin is complexed with phospholipids to increase its overall lipophilicity, it can be more easily absorbed after oral administration, thereby increasing the therapeutic effectiveness of quercetin. Therefore, in some embodiments, the dietary supplement compositions provided herein can include quercetin complexed with one or more phospholipids. The phospholipids that can be complexed with quercetin can be natural or synthetic in nature. In some embodiments, the phospholipid molecules can include acyl residues that are the same or different from each other. Non-limiting examples of acyl residues include palmitic acid, stearic acid, oleic acid, linoleic acid, and linolenic acid. In some embodiments, quercetin can be complexed with glycerophospholipids. Non-limiting examples of glycerophospholipids for complexing with quercetin include phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidic acid, phosphatidylinositol, phosphatidylinositol phosphate, phosphatidylinositol bisphosphate, phosphatidylinositol triphosphate, phosphingolipids (e.g., ceramide phosphorylcholine, ceramidephosphorylethanolamine, or ceramide phosphorylipid), and phosphatidylglycerol cardiolipin.

[0019] Any suitable quercetin and phospholipid ratio can be used.In some embodiments, the mol ratio of quercetin and one or more phospholipids can be about 1:0.8 to about 1:5.For example, the mol ratio of quercetin and one or more phospholipids can be about 1:0.8 to about 1:0.9, about 1:0.9 to about 1:1, about 1:1 to about 1:2, about 1:2 to about 1:3, about 1:3 to about 1:4, about 1:5 to about 1:5 or about 1:1 to about 1:1.5.The quercetin of any suitable source can be used in compositions provided herein.In some embodiments, for example, composition can include quercetin in the blend comprising Sophora japonica extract (for example, wherein Sophora japonica extract includes quercetin) and one or more phospholipids.In some embodiments, quercetin blend can include purified quercetin and one or more phospholipids.

[0020] In some embodiments, the quercetin in the compositions provided herein has a bioavailability of at least 1. For example, the quercetin can have a bioavailability of about 2 to about 100, or about 5 to about 95, or about 10 to about 90, or about 20 to about 80, or about 30 to about 70, or about 40 to about 60, or about 50.

[0021] Compositions provided herein can contain the quercetin of any suitable amount.In some embodiments, for example, compositions can include an amount of at least about 5mg of quercetin.In some embodiments, compositions can include an amount of about 5mg to about 1500mg of quercetin.For example, quercetin can be present in the composition in an amount of about 5mg to about 1250mg, about 5mg to about 1000mg, about 5mg to about 750mg, about 25mg to about 500mg, about 5mg to about 500mg, about 5mg to about 200mg, about 10mg to about 350mg, about 15mg to about 300mg, about 20mg to about 200mg, about 25mg to about 150mg, about 25mg to about 100mg or about 25mg to 75mg.In some embodiments, quercetin can be present in the composition in an amount of about 50mg.

[0022] The dietary supplement compositions provided herein also contain beta glucans. The beta glucans contained in the compositions provided herein can contain one or more forms of beta glucans, such as beta-((1,3)(1,4))-glucans, beta-((1,3)(1,6))-glucans, beta-(1,4)-glucans, and beta-(1,3)-glucans. In some embodiments, the beta glucans are in the form of beta-(1,3)-glucans. Beta-(1,3)-glucans and beta-(1,3)(1,6)-glucans, in particular, can provide immune-enhancing properties, but only beta-(1,3)-glucans can provide these immune-enhancing properties at low doses (e.g., less than 200 mg).

[0023] Compositions provided herein can include any suitable amount of beta glucan. In some embodiments, for example, compositions can include an amount of at least about 35mg of beta glucan. In some embodiments, compositions can include an amount of about 35mg to about 1500mg of beta glucan. For example, beta glucan can be present in the composition in an amount of about 50mg to about 1250mg, about 50mg to about 1000mg, about 100mg to about 750mg, about 100mg to about 500mg, or about 150mg to about 350mg, or about 150mg to about 300mg, or about 150mg to about 250mg, or about 150mg to about 220mg, or about 175mg to about 200mg. In some embodiments, beta glucan can be present in the composition in an amount of about 190mg.

[0024] In some embodiments, the compositions provided herein include vitamin A. The vitamin A in the dietary supplement compositions provided herein may include, but is not limited to, one or more of beta-carotene, retinol, retinal, retinoic acid, and salts thereof. For example, vitamin A may include one or more of beta-carotene, retinyl palmitate, or retinyl acetate. In some embodiments, the compositions include vitamin A as retinyl palmitate. In some embodiments, the compositions include vitamin A as beta-carotene.

[0025] When vitamin A is present in the compositions herein, the compositions can include vitamin A in an amount of at least about 5% of the U.S. Recommended Daily Intake (US Recommended Daily Intake, USRDI) of vitamin A. The U.S. Recommended Daily Intake (USRDI) of vitamins and minerals is defined and elaborated in the Recommended Daily Dietary Allowance-Food and Nutrition Board of the National Academy of Sciences-National Research Council (National Academy of Sciences-National Research Council). In some embodiments, vitamin A is present in the compositions provided herein in an amount of about 10% to about 200% of the USRDI of vitamin A. For example, vitamin A can be present in the compositions provided herein in an amount of about 5% to about 150%, about 10% to about 150%, or about 20% to 125%, or about 30% to about 100%, or about 30% to about 75% or about 50% of the USRDI of vitamin A.

[0026] In some embodiments, when vitamin A is present in the compositions provided herein, the compositions can include vitamin A in an amount of at least about 25mcg RAE, wherein the term "mcg RAE" refers to micrograms of retinol activity equivalents. For example, vitamin A can be present in the compositions provided herein in an amount of from about 25mcg RAE to about 1500mcg RAE, from about 50mcg RAE to about 1000mcg RAE, from about 100mcg RAE to about 1000mcg RAE, from about 200mcg RAE to about 750mcg RAE, from about 300mcg RAE to about 750mcg RAE, from about 400mcg RAE to about 500mcg RAE. In some cases, vitamin A is present in the composition in an amount of from about 400mcg RAE to about 500mcg RAE. In some embodiments, vitamin A is present in the composition in an amount of about 450mcg RAE.

[0027] In some embodiments, provided herein are compositions comprising vitamin C. The vitamin C contained in the dietary supplement compositions provided herein can comprise ascorbic acid or a salt thereof. For example, vitamin C can include but is not limited to one or more of ascorbic acid, sodium ascorbate, calcium ascorbate, potassium ascorbate, magnesium ascorbate, ascorbyl palmitate and ascorbyl stearate. In some embodiments, the composition comprises vitamin C as ascorbic acid. In some embodiments, the composition comprises vitamin C as sodium ascorbate. In some embodiments, the composition comprises one or more natural sources of vitamin C (such as lemon, orange, tomato or acerola).

[0028] When vitamin C is present in the compositions provided herein, the compositions can include vitamin C in an amount of at least about 5% of the USRDI for vitamin C. In some embodiments, vitamin C can be present in the compositions provided herein in an amount of about 10% to about 500% of the USRDI for vitamin C. For example, vitamin C can be present in the composition in an amount of about 10% to about 350%, about 10% to about 250%, about 10% to about 150%, about 15% to about 125%, or about 20% to about 100%, about 25% to about 75%, or about 30% of the USRDI for vitamin C.

[0029] In some embodiments, when vitamin C is present in the compositions provided herein, the compositions can include an amount of at least about 9 mg of vitamin C. For example, the compositions provided herein can include an amount of about 9 mg to about 2000 mg of vitamin C. In some cases, vitamin C is present in the composition in an amount of about 10 mg to about 100 mg. In some embodiments, the composition includes an amount of about 27 mg of vitamin C.

[0030] In some embodiments, the compositions provided herein comprise vitamin D. The vitamin D in the dietary supplement compositions herein may include, but is not limited to, cholecalciferol or ergocalciferol. For example, the vitamin D may comprise one or both of cholecalciferol and ergocalciferol. In some embodiments, the composition comprises vitamin D as cholecalciferol. In some embodiments, the composition comprises vitamin D as cholecalciferol and ergocalciferol.

[0031] When vitamin D is present in the compositions provided herein, the compositions can include vitamin D in an amount of at least about 5% of the USRDI for vitamin D. For example, vitamin D can be present in the compositions provided herein in an amount from about 5% to about 200% of the USRDI for vitamin D (e.g., from about 5% to about 150%, from about 10% to about 100%, from about 25% to about 150%, or from about 15% to about 125%, from about 50% to about 150%, from about 75% to about 125%, or about 100% of the USRDI for vitamin D).

[0032] In some embodiments, when vitamin D is present in the compositions provided herein, the compositions can include an amount of at least about 0.001 mg of vitamin D. For example, the compositions provided herein can include vitamin D in an amount of about 0.001 mg to about 0.1 mg (e.g., about 0.005 mg to about 0.1 mg, about 0.009 mg to about 0.05 mg, or about 0.02 mg).

[0033] In some embodiments, provided herein are compositions that can include zinc. In some cases, the zinc in the compositions provided herein can be in the form of a zinc-amino acid compound, wherein zinc is chelated with an amino acid (e.g., forming a salt with an amino acid). In some embodiments, the zinc-amino acid compound can be the zinc of an amino acid chelate. In some embodiments, the zinc-amino acid compound can be a zinc-amino acid salt. Any suitable amino acid can be used to form a chelate with zinc to produce a zinc-amino acid compound. In some embodiments, the amino acid moiety of the zinc-amino acid compound can be one or more natural or non-natural amino acids. For example, amino acid can be a natural amino acid. As used herein, the term "natural" amino acid refers to one of twenty common amino acids. Natural amino acids can be their D form or L form. For example, natural amino acids can be selected from the group consisting of L-alanine, L-arginine, L-asparagine, L-aspartic acid, L-cysteine, L-glutamic acid, L-glutamine, L-glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine, and mixtures thereof. In some cases, the amino acid is selected from L-glycine and L-aspartic acid.

[0034] In some cases, the zinc included in the compositions provided herein can be in the form of a zinc-amino acid compound complexed with a polysaccharide. Any suitable polysaccharide can be conjugated to form a complex with the zinc-amino acid compound. For example, polysaccharide can include cellulose derivatives, polyhexose (polyhexose), polypentose (polypentose), polydextrose, starch, polygalactan (polygalactan), polymannan (polymannan), chitin, chitosan, chondroitin, polyfructose, polyfructose (such as inulin), pectin, and derivatives thereof. In some embodiments, the degree of polymerization ranges from about 2 to about 100 (for example, about 2-10; about 12-15; about 20-30; about 25-45; about 30-40; about 50-75; about 45-65; about 50-55; about 70-80; about 75-90; or about 92-100) inulin can be conjugated to form a complex with the zinc-amino acid compound.

[0035] The complex of zinc-amino acid compound and polysaccharide can be prepared using any suitable method. For example, the zinc-amino acid polysaccharide complex can be prepared by heating a composition comprising water, one or more zinc-amino acid compounds and one or more polysaccharides at a temperature of about 100°F to about 180°F (e.g., about 110°F to about 160°F, or about 120°F to about 150°F; or about 100°F; about 110°F; about 120°F; about 125°F; about 130°F; about 140°F; about 145°F; about 150°F; about 160°F; about 165°F; about 170°F; about 175°F; and about 180°F). In some embodiments, the composition can be heated at about 140°F to about 180°F. In some embodiments, the composition can be heated at about 160°F. In some embodiments, the composition can be heated for about 5 minutes to about 30 minutes (e.g., about 10 minutes to about 25 minutes, about 15 minutes to 20 minutes, or about 5 minutes; about 10 minutes; about 15 minutes; about 20 minutes; about 25 minutes and about 30 minutes). In some embodiments, the composition can be heated for about 20 minutes. In some embodiments, the composite can be dried after heating, for example, to a moisture content of less than about 15% (e.g., less than about 14%, less than about 12%, less than about 10%, less than about 8%, less than about 5%, and less than about 2%).

[0036] Complexes of zinc-amino acid compounds and polysaccharides can be prepared using ratios of zinc-amino acid compound to polysaccharide ranging, for example, from 10:1 to 1:10 (e.g., 10:1; 8:1; 7:1; 6:1; 5:1; 4:1; 3:1; 2:1; 1:1.5; 1:1; 1:1.5; 1:2; 1:3; 1:4; 1:5; 1:6; and 1:10). For example, the ratio of zinc-amino acid compound to polysaccharide can be 5:1 or 1:1. The zinc-amino acid / polysaccharide complex can comprise zinc in any suitable form, any suitable amino acid, and any suitable polysaccharide. For example, the zinc-amino acid compound / polysaccharide complex can comprise one or more of zinc sulfate, zinc picolinate, zinc citrate, zinc gluconate, zinc acetate, zinc glycerate, and zinc monomethionate. The amino acids in the zinc-amino acid / polysaccharide complex may include, but are not limited to, one or more of methionine, glycine, aspartic acid, alanine, arginine, asparagine, cysteine, glutamic acid, glutamine, histidine, isoleucine, leucine, lysine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, and valine. The polysaccharides in the zinc-amino acid / polysaccharide complex may be selected from, but are not limited to, cellulose, polyhexoses, polypentoses, polyglucoses, starches, polygalactans, polymannans, chitin, chitosan, chondroitin, polyfructose, inulin, and pectin. In some cases, the zinc-amino acid compound / polysaccharide complex may comprise zinc sulfate, glycine, and inulin, optionally in combination with sodium citrate. The zinc-amino acid compound / polysaccharide complex can comprise, for example, about 30% to about 60% by weight zinc sulfate, about 25% to about 50% by weight glycine, about 7% to about 13% by weight inulin, and about 7% to about 11% by weight sodium citrate (e.g., about 35% to about 53% by weight zinc sulfate, about 29% to about 45% by weight glycine, about 8.5% to about 11.5% by weight inulin, and about 8% to about 10% by weight sodium citrate, or about 35.3% to about 53% by weight zinc sulfate, about 29.6% to about 44.3% by weight glycine, about 8.9% to about 10.9% by weight inulin, and about 8.1% to about 9.9% by weight sodium citrate). In some cases, the zinc-amino acid / polysaccharide complex can further comprise sodium alginate (e.g., when the sodium alginate is a coating on the zinc-amino acid / polysaccharide complex).Any other suitable coating material (e.g., stearic acid, carbomer copolymer, shellac, hypromellose, sodium carboxymethylcellulose, carrageenan, cellaburate, ethylcellulose, glyceryl monooleate, pregelatinized modified starch, glyceryl monostearate, guar gum, hydroxypropyl-β-cyclodextrin, hydroxypropylcellulose, polyethylene oxide, polyvinyl acetate dispersion, pregelatinized starch, xanthan gum, alginic acid, locust bean gum, hydrogenated vegetable oil, monoglycerides and / or diglycerides) may also be included in any suitable amount. For example, the zinc-amino acid compound / polysaccharide complex may further comprise about 2% to about 15% by weight (e.g., about 2% to about 5%, about 5% to about 8%, about 8% to about 10%, about 10% to about 12%, or about 12% to about 15%) of sodium alginate.

[0037] In some embodiments, the dietary supplement composition may comprise two or more different zinc-amino acid compounds or zinc-amino acid / polysaccharide complexes. For example, in some cases, the zinc-amino acid compound or zinc-amino acid / polysaccharide complex may comprise a zinc-amino acid compound comprising aspartate and glycine (e.g., about 75% aspartate and about 25% glycine). In some cases, the zinc-amino acid compound / polysaccharide complex may comprise polyfructose. In some cases, the zinc-amino acid compound / polysaccharide complex may comprise inulin having a degree of polymerization ranging from about 2 to about 100. In some cases, the zinc-amino acid compound / polysaccharide complex may comprise inulin having a degree of polymerization of about 12-15.

[0038] The dietary supplement compositions provided herein can be formulated in any suitable manner. For example, the compositions provided herein can be in the form of a liquid, solution, suspension, tablet, powder, cream, mist, atomized vapor, aerosol, soft gelatin capsule, hard gelatin capsule, gums, lozenge, candy, sachet, gel, sweet, milk shake, stick, or food supplement.

[0039] In some cases, the dietary supplement compositions provided herein can be formulated for oral administration and can include one or more suitable excipients, flavorings, coloring agents and other ingredients. For oral administration, tablets or capsules can be prepared with pharmaceutically acceptable excipients such as adhesives, fillers, lubricants, disintegrants or wetting agents. In some cases, tablets can include coatings (e.g., coatings based on polymers or polysaccharides with or without plasticizers and / or pigments). Liquid preparations for oral administration can take the form of, for example, solutions, syrups or suspensions, or they can exist as dry products constituted with saline or other suitable liquid solvents before use. In some cases, liquid preparations can suitably include pharmaceutically acceptable additives such as suspending agents, emulsifiers, non-aqueous solvents, preservatives, buffer salts, flavorings, coloring agents and sweeteners. Preparations for oral administration can be suitably formulated to provide the controlled release of one or more compounds. In some cases, tablets or capsules can be formulated with methacrylic acid copolymers (e.g., L100-55 or S100) is coated for release outside the stomach (e.g., in the intestine, colon, or both).

[0040] In some cases, the dietary supplement compositions provided herein can include a pharmaceutically acceptable carrier for administration to a mammal, including but not limited to sterile aqueous or non-aqueous solutions, suspensions, and emulsions. Examples of non-aqueous solvents include but are not limited to propylene glycol, polyethylene glycol, vegetable oils, and organic esters. Aqueous carriers include but are not limited to water, alcohol, saline, and buffered solutions. Pharmaceutically acceptable carriers can also include physiologically acceptable aqueous solvents (e.g., normal saline) or other carriers suitable for oral administration.

[0041] In some cases, provided herein is a dietary supplement composition in the form of a capsule or tablet, which is formulated as a unit dose equal to the daily required dose of a specific mammal. For example, if a specific medicament having a dosage of 100 mg is to be administered to a mammal, each tablet can include the medicament of about 100 mg weight. Provided herein is a composition that can be formulated to be applied to any suitable mammal. For example, provided herein is a composition that can be applied to humans or other mammals (for example, dogs, cats, mice, rats, rabbits, cattle, horses, pigs, or sheep). In some cases, the total daily dose can be prepared and administered in the form of one or more dosage units (for example, two tablets or capsules, three tablets or capsules, four tablets or capsules, five tablets or capsules, or six tablets or capsules). For example, in some cases, exemplary dietary supplement compositions can be provided with three separate tablets or capsules.

[0042] Also provided herein is a method for providing beta glucan, quercetin and one or more of vitamin A, vitamin C, vitamin D and zinc to a subject (e.g., a mammal, such as a human, mouse, rat, rabbit, dog, cat, cattle, horse, pig or sheep). In some cases, the method may include administering to a subject a composition comprising beta glucan, quercetin and one or more of vitamin A, vitamin C, vitamin D and zinc, wherein the subject exhibits increased immunity compared to a corresponding subject not administered a composition as described herein. For example, the composition may comprise beta glucan in the form of beta-(1,3)-glucan to improve the immunity of a subject to which the composition has been administered. In some cases, the composition may comprise quercetin having a bioavailability greater than 1 (e.g., about 25 to about 75) to improve the immunity of a subject to which the composition has been administered.

[0043] In some cases, the methods provided herein can be used to treat a disease or clinical condition (e.g., an immune-related disorder such as, but not limited to, Addison disease, Celiac disease, dermatomyositis, Graves' disease, Hashimoto thyroiditis, multiple sclerosis, myasthenia gravis, pernicious anemia, reactive arthritis, rheumatoid arthritis, Sjögren syndrome, type 1 diabetes, psoriasis, irritable bowel syndrome, asthma, ataxia telangiectasia, autoimmune polyglandular syndrome, Burkitt lymphoma, DiGeorge syndrome, chronic myeloid leukemia, or human immunodeficiency virus (HIV) / acquired immunodeficiency syndrome (AIDS)) in a subject by enhancing the subject's immunity.

[0044] In some cases, the methods provided herein can be used to reduce the likelihood of developing a disease or clinical condition (e.g., an immune-related disorder such as, but not limited to, Addison's disease, celiac disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, multiple sclerosis, myasthenia gravis, pernicious anemia, reactive arthritis, rheumatoid arthritis, Sjögren's syndrome, type 1 diabetes or psoriasis, irritable bowel syndrome, asthma, ataxia telangiectasia, autoimmune polyglandular syndrome, Burkitt's lymphoma, DiGeorge syndrome, chronic myeloid leukemia, or HIV / AIDS) in a subject by improving the subject's immunity.

[0045] In some cases, the methods provided herein can be used to reduce the likelihood of progression of a disease or clinical condition (e.g., an immune-related disorder such as, but not limited to, Addison's disease, celiac disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, multiple sclerosis, myasthenia gravis, pernicious anemia, reactive arthritis, rheumatoid arthritis, Sjögren's syndrome, type 1 diabetes, psoriasis, irritable bowel syndrome, asthma, ataxia telangiectasia, autoimmune polyglandular syndrome, Burkitt's lymphoma, DiGeorge syndrome, chronic myeloid leukemia, or HIV / AIDS) in a subject by improving the subject's immunity.

[0046] The method may include administering to the subject an effective amount of a composition provided herein, wherein the composition comprises beta glucan, quercetin, and one or more of vitamin A, vitamin C, vitamin D, and zinc (e.g., wherein the beta glucan is in the form of beta-(1,3)-glucan and the quercetin has a bioavailability greater than 1). The effective amount of the composition may be, for example, an amount that effectively improves the immune function of the subject to whom the composition is administered. For example, the immune function of the subject to whom the composition is administered may be increased by at least 5% (e.g., at least 10%, at least 20%, at least 25%, at least 30%, at least 50%, or at least 75%). Immune function may be assessed using any appropriate method. For example, immune function may be assessed by measuring B cell activity and / or B cell count, T cell activity and / or T cell count, T cell-dependent antibody response, natural killer cell cytotoxicity, and / or cytokine response). Effectiveness may also be assessed based on the incidence of immune disorders in subjects administered the compositions provided herein relative to the incidence of immune disorders in subjects administered a control composition lacking the beta glucan and / or quercetin contained in the compositions as described herein. In some cases, an effective amount can be a daily dose as shown in the table herein.

[0047] Exemplary embodiments

[0048] Embodiment 1 is a composition comprising (a) beta glucan, (b) quercetin, and (c) one or more of vitamin A, vitamin C, vitamin D, and zinc.

[0049] Embodiment 2 is the composition of embodiment 1, wherein the beta glucan is in the form of beta-(1,3)-glucan.

[0050] Embodiment 3 is the composition of embodiment 1 or 2, wherein the quercetin is in a blend comprising Sophora japonica extract and one or more phospholipids.

[0051] Embodiment 4 is the composition of any one of embodiments 1-3, wherein the quercetin is complexed with one or more phospholipids.

[0052] Embodiment 5 is the composition of any one of embodiments 1-4, wherein the composition comprises vitamin A.

[0053] Embodiment 6 is the composition of any one of embodiments 1-5, wherein the composition comprises vitamin C.

[0054] Embodiment 7 is the composition of any one of embodiments 1-6, wherein the composition comprises vitamin D.

[0055] Embodiment 8 is the composition of any one of embodiments 1-7, wherein the composition comprises zinc.

[0056] Embodiment 9 is the composition of any one of embodiments 1-8, wherein the composition comprises vitamin A, vitamin C, vitamin D, and zinc.

[0057] Embodiment 10 is the composition of embodiment 8, wherein the zinc is in the form of amino acid chelated zinc.

[0058] Embodiment 11 is a composition comprising beta glucan, quercetin, vitamin D, vitamin A, vitamin C, and zinc.

[0059] Embodiment 12 is the composition of embodiment 11, wherein the beta glucan is in the form of beta-(1,3)-glucan.

[0060] Embodiment 13 is the composition of embodiment 11 or embodiment 12, wherein the quercetin is in a blend comprising Sophora japonica extract and one or more phospholipids.

[0061] Embodiment 14 is the composition of any one of embodiments 11-13, wherein the quercetin is complexed with one or more phospholipids.

[0062] Embodiment 15 is the composition of any one of embodiments 11-14, wherein the zinc is a zinc-amino acid compound.

[0063] Embodiment 16 is the composition of any one of embodiments 11-15, wherein the zinc is a zinc-amino acid compound conjugated to a polysaccharide.

[0064] Embodiment 17 is the composition of any one of embodiments 11-16, wherein the beta glucan is present in an amount of about 35 mg to about 1500 mg.

[0065] Embodiment 18 is the composition of any one of embodiments 11-17, wherein quercetin is present in an amount from about 5 mg to about 1500 mg.

[0066] Embodiment 19 is the composition of any one of embodiments 11-18, wherein vitamin A is present in an amount from about 25 meg RAE to about 1500 meg RAE.

[0067] Embodiment 20 is the composition of any one of embodiments 11-19, wherein vitamin C is present in an amount from about 9 mg to about 2000 mg.

[0068] Embodiment 21 is the composition of any one of embodiments 11-20, wherein vitamin D is present in an amount of about 0.005 mg to about 0.1 mg.

[0069] Embodiment 22 is the composition of any one of embodiments 11-21, wherein zinc is present in an amount from about 1 mg to about 75 mg.

[0070] Embodiment 23 is the composition of any one of embodiments 11-22, wherein the quercetin has a bioavailability of greater than 1, or from about 2 to about 100, or from about 25 to about 75, or from about 40 to about 60.

[0071] Embodiment 24 is the composition of any one of embodiments 11-23, wherein the beta glucan is isolated from algae.

[0072] Embodiment 25 is the composition of embodiment 24, wherein the algae is Euglena gracilis.

[0073] Embodiment 26 is the composition of any one of embodiments 11-25, wherein the composition is in the form of a tablet or capsule.

[0074] Embodiment 27 is a composition comprising (a) beta glucan in an amount of about 35 mg to about 1500 mg, (b) quercetin in an amount of about 5 mg to about 1500 mg, (c) vitamin A in an amount of about 25 mcg RAE to about 1500 mcg RAE, (d) vitamin C in an amount of about 9 mg to about 2000 mg, (e) vitamin D in an amount of about 0.005 mg to about 0.1 mg, and (f) zinc in an amount of about 1 mg to about 75 mg.

[0075] Embodiment 28 is the composition of embodiment 27, wherein the beta glucan is present in an amount from about 100 mg to about 300 mg.

[0076] Embodiment 29 is the composition of embodiment 27 or 28, wherein quercetin is present in an amount of about 5 mg to about 200 mg.

[0077] Embodiment 30 is the composition of any one of embodiments 27-29, wherein vitamin A is present in an amount of about 400 meg RAE to about 500 meg RAE.

[0078] Embodiment 31 is the composition of any one of embodiments 27-30, wherein vitamin C is present in an amount of about 10 mg to about 100 mg.

[0079] Embodiment 32 is the composition of any one of embodiments 27-31, wherein vitamin D is present in an amount of about 0.009 mg to about 0.05 mg.

[0080] Embodiment 33 is the composition of any one of embodiments 27-32, wherein zinc is present in an amount from about 5 mg to about 50 mg.

[0081] Embodiment 34 is the composition of any one of embodiments 27-33, wherein the zinc is in the form of amino acid chelated zinc.

[0082] Embodiment 35 is the composition of any one of embodiments 27-34, wherein the quercetin is in a blend comprising Sophora japonica extract and one or more phospholipids.

[0083] Embodiment 36 is the composition of any one of embodiments 27-35, wherein the quercetin is complexed with one or more phospholipids.

[0084] Embodiment 37 is the composition of any one of embodiments 27-36, wherein the beta glucan is in the form of beta (1,3)-glucan.

[0085] Embodiment 38 is a composition comprising (a) at least about 35 mg of beta glucan, (b) at least about 5 mg of quercetin, (c) at least about 25 mcg RAE of vitamin A, (d) at least about 9 mg of vitamin C, (e) at least about 0.005 mg of vitamin D, and (f) at least about 1 mg of zinc.

[0086] The compositions and methods herein are further described in the following examples, which do not limit the scope of the disclosure.

[0087] Example

[0088] Example 1 - Exemplary Dietary Supplement Compositions

[0089] A dietary supplement was prepared with the composition shown in the following Table 1. The dietary supplement was prepared as a vegetarian capsule using hydroxypropylmethylcellulose and further comprising microcrystalline cellulose and magnesium stearate as binders and silicon dioxide as a glidant.

[0090] Table 1. Exemplary dietary supplement compositions.

[0091] Vitamin A (as retinyl palmitate) 400-500mcg RAE Vitamin C (as ascorbic acid) 24-30mg Vitamin D (as cholecalciferol) 0.01-0.03mg Zinc (as zinc-amino acid oligofructose complex) 10-12 mg β-Glucan (as β-(1,3)-glucan) 175-225mg Quercetin Blend (Contains Sophora japonica Extract and Phospholipids) 35-65mg

[0092] Example 2 - Exemplary Dietary Supplement Compositions

[0093] A dietary supplement was prepared with the composition shown in Table 2 below.

[0094] Table 2. Exemplary dietary supplement compositions.

[0095] Vitamin A (as retinyl palmitate) 400-500mcg RAE Vitamin C (as ascorbic acid) 24-30mg Vitamin D (as cholecalciferol) 0.01-0.03mg Zinc (as zinc-amino acid oligofructose complex) 10-12 mg β-Glucan (as β-(1,3)-glucan) 30-500mg Quercetin Blend (Contains Sophora japonica Extract and Phospholipids) 500-2000mg

[0096] Example 3 - Exemplary Dietary Supplement Compositions

[0097] A dietary supplement was prepared with the composition shown in Table 2 below.

[0098] Table 3. Exemplary dietary supplement compositions.

[0099] Vitamin A (as retinyl palmitate) 400-500mcg RAE Vitamin C (as ascorbic acid) 24-30mg Vitamin D (as cholecalciferol) 0.01-0.03mg Zinc (as zinc-amino acid oligofructose complex) 12-16mg β-Glucan (as β-(1,3)-glucan) 30-500mg Quercetin Blend (Contains Sophora japonica Extract and Phospholipids) 35-65mg

[0100] Example 4 - Exemplary Dietary Supplement Compositions A dietary supplement was prepared with the composition shown in Table 2 below.

[0101] Table 4. Exemplary dietary supplement compositions.

[0102] Vitamin A (as retinyl palmitate) 400-500mcg RAE Vitamin C (as ascorbic acid) 50-200mg Vitamin D (as cholecalciferol) 0.01-0.03mg Zinc (as zinc-amino acid oligofructose complex) 10-12 mg β-Glucan (as β-(1,3)-glucan) 30-500mg Quercetin Blend (Contains Sophora japonica Extract and Phospholipids) 35-65mg

[0103] Example 5 - Exemplary Dietary Supplement Compositions A dietary supplement was prepared with the composition shown in Table 2 below.

[0104] Table 5. Exemplary dietary supplement compositions.

[0105] Vitamin A (as retinyl palmitate) 400-500mcg RAE Vitamin C (as ascorbic acid) 24-30mg Vitamin D (as cholecalciferol) 0.01-0.03mg Zinc (as zinc-amino acid oligofructose complex) 12-16mg β-Glucan (as β-(1,3)-glucan) 30-500mg Quercetin Blend (Contains Sophora japonica Extract and Phospholipids) 500-2000mg

[0106] Example 6 - Exemplary Dietary Supplement Compositions A dietary supplement was prepared with the composition shown in Table 2 below.

[0107] Table 6. Exemplary dietary supplement compositions.

[0108] Vitamin A (as retinyl palmitate) 400-500 mcg RAE Vitamin C (as ascorbic acid) 50-200 mg Vitamin D (as cholecalciferol) 0.01-0.03 mg Zinc (as zinc-amino acid oligofructose complex) 10-12 mg β-Glucan (as β-(1,3)-glucan) 30-500 mg Quercetin Blend (Contains Sophora japonica Extract and Phospholipids) 500-2000 mg

[0109] Example 7 - Exemplary Dietary Supplement Compositions A dietary supplement was prepared with the composition shown in Table 2 below.

[0110] Table 7. Exemplary dietary supplement compositions.

[0111] Vitamin A (as retinyl palmitate) 400-500mcg RAE Vitamin C (as ascorbic acid) 50-200mg Vitamin D (as cholecalciferol) 0.01-0.03mg Zinc (as zinc-amino acid oligofructose complex) 12-16mg β-Glucan (as β-(1,3)-glucan) 30-500mg Quercetin Blend (Contains Sophora japonica Extract and Phospholipids) 35-65mg

[0112] Example 8 - Exemplary Dietary Supplement Compositions

[0113] A dietary supplement was prepared with the composition shown in Table 2 below.

[0114] Table 8. Exemplary dietary supplement compositions.

[0115] Vitamin A (as retinyl palmitate) 400-500mcg RAE Vitamin C (as ascorbic acid) 50-200mg Vitamin D (as cholecalciferol) 0.01-0.03mg Zinc (as zinc-amino acid oligofructose complex) 12-16mg β-Glucan (as β-(1,3)-glucan) 30-500mg Quercetin Blend (Contains Sophora japonica Extract and Phospholipids) 500-2000mg

[0116] Other implementation plans

[0117] It should be understood that although the invention has been described in conjunction with the detailed description of the invention, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages and modifications are within the scope of the appended claims.

Claims

1. A composition comprising: (a) β-glucan, (b) quercetin, and (c) one or more of vitamin A, vitamin C, vitamin D and zinc. 2 . The composition according to claim 1 , wherein the β glucan is in the form of β-(1,3)-glucan.

3. The composition of claim 1, wherein the quercetin is in a blend comprising a Sophora japonica extract and one or more phospholipids.

4. The composition of claim 1, wherein the quercetin is complexed with one or more phospholipids.

5. The composition of claim 1, wherein the composition comprises vitamin A.

6. The composition of claim 1, wherein the composition comprises vitamin C.

7. The composition of claim 1, wherein the composition comprises vitamin D.

8. The composition of claim 1, wherein the composition comprises zinc.

9. The composition of claim 1, wherein the composition comprises vitamin A, vitamin C, vitamin D and zinc.

10. The composition of claim 8, wherein the zinc is in the form of amino acid chelated zinc.

11. A composition comprising: Beta Glucan, Quercetin, Vitamin D, Vitamin A, Vitamin C and Zinc.

12. The composition of claim 11, wherein the β glucan is in the form of β-(1,3)-glucan.

13. The composition of claim 11, wherein the quercetin is in a blend comprising Sophora japonica extract and one or more phospholipids.

14. The composition of claim 11, wherein the quercetin is complexed with one or more phospholipids.

15. The composition according to claim 11, wherein the zinc is a zinc-amino acid compound.

16. The composition of claim 11, wherein the zinc is a zinc-amino acid compound conjugated to a polysaccharide.

17. The composition of claim 11, wherein the beta glucan is present in an amount of about 35 mg to about 1500 mg.

18. The composition of claim 11, wherein the quercetin is present in an amount of about 5 mg to about 1500 mg.

19. The composition of claim 11, wherein the vitamin A is present in an amount of about 25 meg RAE to about 1500 meg RAE.

20. The composition of claim 11, wherein the vitamin C is present in an amount of about 9 mg to about 2000 mg.

21. The composition of claim 11, wherein the vitamin D is present in an amount of about 0.005 mg to about 0.1 mg.

22. The composition of claim 11, wherein the zinc is present in an amount of about 1 mg to about 75 mg.

23. The composition of claim 11, wherein the quercetin has a bioavailability of greater than 1, or from about 2 to about 100, or from about 25 to about 75, or from about 40 to about 60.

24. The composition of claim 11, wherein the beta glucan is isolated from algae.

25. The composition of claim 24, wherein the algae is Euglena gracilis.

26. The composition of claim 11, wherein the composition is in the form of a tablet or a capsule.

27. A composition comprising: (a) beta glucan in an amount of about 35 mg to about 1500 mg, (b) quercetin in an amount of about 5 mg to about 1500 mg, (c) vitamin A in an amount of about 25 mcg RAE to about 1500 mcg RAE, (d) vitamin C in an amount of about 9 mg to about 2000 mg, (e) vitamin D in an amount of about 0.005 mg to about 0.1 mg, and (f) zinc in an amount from about 1 mg to about 75 mg.

28. The composition of claim 27, wherein the beta glucan is present in an amount of about 100 mg to about 300 mg.

29. The composition of claim 27, wherein the quercetin is present in an amount of about 5 mg to about 200 mg.

30. The composition of claim 27, wherein the vitamin A is present in an amount of about 400 meg RAE to about 500 meg RAE.

31. The composition of claim 27, wherein the vitamin C is present in an amount of about 10 mg to about 100 mg.

32. The composition of claim 27, wherein the vitamin D is present in an amount of about 0.009 mg to about 0.05 mg.

33. The composition of claim 27, wherein the zinc is present in an amount of about 5 mg to about 50 mg.

34. The composition of claim 27, wherein the zinc is in the form of amino acid chelated zinc.

35. The composition of claim 27, wherein the quercetin is in a blend comprising Sophora japonica extract and one or more phospholipids.

36. The composition of claim 27, wherein the quercetin is complexed with one or more phospholipids.

37. The composition of claim 27, wherein the beta glucan is in the form of beta (1,3)-glucan.

38. A composition comprising: (a) at least about 35 mg of beta glucan, (b) at least about 5 mg of quercetin, (c) at least about 25 mcg RAE of vitamin A, (d) at least about 9 mg of vitamin C, (e) at least about 0.005 mg of vitamin D, and (f) at least about 1 mg of zinc.