HK40070100B - Super-oxide dismutase soluble fiber compositions - Google Patents

Description

Superoxide dismutase soluble fiber composition

Technical Field

The present disclosure relates generally to compositions comprising superoxide dismutase and soluble fiber. The composition can be used as a dietary supplement and for improving health and well-being.

Background

Superoxide dismutase (SOD) is a group of metalloenzymes that prevent Reactive Oxygen Species (ROS) from damaging cells. SOD catalyzed superoxide anion radical (O) ₂ ^- ) Disproportionation into molecular oxygen and hydrogen peroxide (H) ₂ O ₂ ). ROS in cells can destroy nucleic acids, proteins, and lipids, leading to reduced cell function and possible apoptosis. Thus, the ability to convert ROS to harmless molecules is critical to protecting cellular function and overall health.

Although almost all organisms naturally produce some type of SOD, the level of SOD produced in cells decreases with the age of the subject or with some health disorder. In addition, the presence of various contaminants and toxins in the environment can lead to elevated levels of ROS in cells. Therefore, supplementation of naturally occurring SOD by meal is important to maintain health.

Another important dietary ingredient is soluble fiber. The soluble fiber absorbs moisture and forms a gel in the digestive tract. Soluble fiber has many benefits to the gut including slowing the digestion of certain types of lipids and carbohydrates, helping to prevent ingestion of dietary cholesterol and preventing a surge in blood glucose levels. Soluble fiber is also important for maintaining a healthy intestinal microbiota, as intestinal bacteria can ferment certain types of soluble fiber. The content of soluble fiber in modern diets is generally low and supplementation is often required to improve health.

Diabetes (diabetes) is a common disorder of carbohydrate metabolism. In the united states, over 3000 tens of thousands have diabetes. Over the last 20 years, as the united states population ages and becomes more and more overweight or obese, the number of adults diagnosed with diabetes increases by a factor of two. In diabetics, the normal ability of the body to utilize glucose is compromised, resulting in elevated blood glucose levels. Diabetes is associated with an increased risk of cardiovascular or circulatory diseases or disorders.

Dietary fiber, such as soluble fiber, has been shown to attenuate glycemic response to meal. When fermented by intestinal bacteria, fibers also produce metabolites of short chain fatty acids [ SCFA ] that are involved in glucose homeostasis. However, high fiber foods can cause gastric discomfort, and certain fiber supplements can also cause gastric discomfort.

Antioxidants have been shown to have beneficial effects in humans against free radicals, which are associated with many disease processes. However, the absorption of the effective metabolites of many antioxidants (e.g. polyphenols) depends on the microbial metabolism of the antioxidants in the intestinal tract. Thus, for many nutritional supplements, these potent polyphenol metabolites are not produced and the antioxidant activity of the supplement is limited.

Summary of The Invention

The present invention relates to compositions comprising from about 0.5 units/mg to about 500 units/mg superoxide dismutase and soluble fiber. In some embodiments of the invention, the composition comprises about 1 unit/mg to about 100 units/mg of superoxide dismutase. In some embodiments of the invention, the composition comprises about 5 units/mg to about 50 units/mg of superoxide dismutase. In some embodiments of the invention, the composition comprises about 10 units/mg to about 15 units/mg of superoxide dismutase. In some embodiments of the invention, the composition comprises about 14 units/mg superoxide dismutase.

In some embodiments of the invention, the superoxide dismutase in the composition is extracted from melon, bovine liver, heterotrophic bacteria, or marine phytoplankton. In some embodiments of the invention, the superoxide dismutase is copper/zinc superoxide dismutase, iron/manganese superoxide dismutase, or nickel superoxide dismutase.

In some embodiments of the invention, the superoxide dismutase in the composition is extracted from a plant. In some embodiments, the plant is a fruit, grain, or tuber. In some embodiments, the plant is a fruit selected from melon, citrus fruit, peach, pear, apple, or banana. In some embodiments, the plant is a cereal selected from the group consisting of wheat, barley, rye, millet, oat, spelt (spelt), barker (bulger), sorghum, and fargesia (farro). In some embodiments, the plant is a tuber selected from horseradish, potato, yam, sweet potato, tapioca, or dahlia.

In some embodiments of the invention, the superoxide dismutase in the composition is extracted from an animal. In some embodiments, the animal is a cow, pig, sheep, or goat.

In some embodiments of the invention, the superoxide dismutase in the composition is extracted from the microorganism. In some embodiments, the microorganism is a phytoplankton or a bacterium.

In some embodiments of the invention, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:100 to about 1:1000. In some embodiments of the invention, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:200 to about 1:800. In some embodiments of the invention, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:300 to about 1:700. In some embodiments of the invention, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:500 to about 1:700. In some embodiments of the invention, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:650 to about 1:675.

In some embodiments of the invention, the soluble fiber in the composition is a water-soluble polysaccharide. In some embodiments of the invention, the soluble fiber in the composition is isolated from corn, wheat, barley, rye, beans, apples, pears, peaches, citrus fruits, berries, peas, rice bran, or oats. In some embodiments of the invention, the soluble fiber in the composition is selected from the group consisting of soluble corn fiber, inulin, dextrin, guar gum, oligosaccharides, galactopolysaccharides, fructooligosaccharides, lactulose, digestion resistant starch, xylooligosaccharides, and isomaltooligosaccharides. In some embodiments of the invention, the soluble fiber in the composition is soluble corn fiber. In some embodiments of the present disclosure, the soluble fiber in the composition is digestion-resistant maltodextrin.

In some embodiments of the invention, the composition is in powder form. In some embodiments, the powder composition comprises from about 0.1ppm to about 10ppm by weight of superoxide dismutase. In some embodiments, the powder composition comprises from about 0.5ppm to about 5ppm by weight of superoxide dismutase. In some embodiments, the powder composition comprises from about 0.7ppm to about 2ppm by weight of superoxide dismutase. In some embodiments, the powder composition comprises from about 0.8ppm to about 1.2ppm by weight of superoxide dismutase. In some embodiments, the powder composition comprises from about 1% to about 90% by weight of soluble fiber. In some embodiments, the powder composition comprises from about 1% to about 50% by weight of soluble fiber. In some embodiments, the powder composition comprises from about 5% to about 25% by weight of soluble fiber. In some embodiments, the powder composition comprises from about 10% to about 20% by weight of soluble fiber. In some embodiments, the powder composition comprises from about 12% to about 14% by weight of soluble fiber.

In some embodiments of the invention, the composition is in the form of a gel. In some embodiments of the invention, the composition is in liquid form. In some embodiments, the gel or liquid composition comprises about 0.005mg/mL to about 3.0mg/mL superoxide dismutase. In some embodiments, the gel or liquid composition comprises about 0.01mg/mL to about 2.0mg/mL superoxide dismutase. In some embodiments, the gel or liquid composition comprises about 0.05mg/mL to about 1.0mg/mL superoxide dismutase. In some embodiments, the gel or liquid composition comprises about 0.1mg/mL to about 0.5mg/mL superoxide dismutase.

In some embodiments, the gel or liquid composition comprises about 50mg/mL to about 1000mg/mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 70mg/mL to about 500mg/mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 90mg/mL to about 250mg/mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 100mg/mL to about 200mg/mL of soluble fiber.

In some embodiments of the invention, the composition comprising superoxide dismutase and soluble fiber further comprises fruit juice. In some embodiments, the juice is a pomegranate juice, red grape juice, blueberry juice, black sweet cherry juice, sour cherry juice, medlar juice, brazil berry juice, blackberry juice, raspberry juice, strawberry juice, gooseberry juice, cranberry juice, orange juice, grapefruit juice, watermelon juice, beet juice, apple juice, lemon juice, lime juice, litchi juice, pineapple juice, prune juice, or a combination thereof. In some embodiments, the juice is a concentrated pomegranate juice, red grape juice, blueberry juice, black sweet cherry juice, sour cherry juice, medlar juice, brazil berry juice, blackberry juice, raspberry juice, strawberry juice, gooseberry juice, cranberry juice, orange juice, grapefruit juice, watermelon juice, beet juice, apple juice, lemon juice, lime juice, litchi juice, pineapple juice, prune juice, or a combination thereof. In some embodiments, the concentrated juice removes about 60% to about 97% of the water in the juice. In some embodiments, the concentrated juice removes from about 85% to about 95% of the water in the juice. In some embodiments, the composition comprises about 5mg/mL to about 200mg/mL of concentrated juice. In some embodiments, the composition comprises about 75mg/mL to about 150mg/mL of concentrated pomegranate juice. In some embodiments, the composition comprises about 75mg/mL to about 150mg/mL of concentrated red grape juice. In some embodiments, the composition comprises about 25mg/mL to about 100mg/mL of concentrated blueberry juice. In some embodiments, the composition comprises about 20mg/mL to about 80mg/mL of concentrated black cherry juice. In some embodiments, the composition comprises about 20mg/mL to about 80mg/mL of concentrated sour cherry juice. In some embodiments, the composition comprises about 2mg/mL to about 20mg/mL of concentrated medlar juice. In some embodiments, the composition comprises about 2mg/mL to about 20mg/mL of concentrated brazil juice.

In some embodiments of the invention, the composition comprising superoxide dismutase and soluble fiber further comprises aloe vera (aloe vera). In some embodiments, the aloe is aloe vera concentrate. In some embodiments, concentrating aloe removes about 60% to about 97% of the aloe moisture. In some embodiments, the composition comprises about 2mg/mL to about 20mg/mL of aloe vera concentrate.

In some embodiments of the invention, the composition comprising superoxide dismutase and soluble fiber further comprises green tea. In some embodiments, the green tea is concentrated green tea. In some embodiments, the concentrated green tea is a green tea extract. In some embodiments, the composition comprises from about 2mg/mL to about 20mg/mL of concentrated green tea.

In some embodiments of the invention, the composition comprising superoxide dismutase and soluble fiber further comprises resveratrol. In some embodiments, the composition comprises from about 0.5mg/mL to about 6mg/mL resveratrol.

In some embodiments of the invention, the gel composition comprising superoxide dismutase and soluble fiber further comprises carboxymethyl cellulose. In some embodiments, the composition comprises about 0.5mg/mL to about 5.0mg/mL of carboxymethyl cellulose.

In some embodiments of the invention, the gel composition comprising superoxide dismutase and soluble fiber further comprises xanthan gum. In some embodiments, the composition comprises about 0.5mg/mL to about 5.0mg/mL xanthan gum.

The invention also relates to a composition comprising: a) About 0.5 units/mg to about 100 units/mg superoxide dismutase; b) A soluble fiber; and c) at least two juices selected from the group consisting of pomegranate juice, red grape juice, blueberry juice, black cherry juice, sour cherry juice, medlar juice, and brazil berry juice. In some embodiments, the composition comprises at least three juices. In some embodiments, the composition comprises at least four juices. In some embodiments, the composition comprises at least five juices. In some embodiments, the composition comprises at least six juices. In some embodiments, the composition comprises pomegranate juice, red grape juice, blueberry juice, black cherry juice, sour cherry juice, medlar juice, and brazil berry juice.

In some embodiments of the composition, the juice is a concentrated juice. In some embodiments of the composition, the soluble fiber is soluble corn fiber. In some embodiments, the soluble corn fiber is digestion resistant maltodextrin.

The invention also relates to a composition comprising: a) Superoxide dismutase; b) Soluble corn fiber; c) At least two juices selected from the group consisting of pomegranate juice, red grape juice, blueberry juice, black sweet cherry juice, sour cherry juice, medlar juice, and brazil berry juice; d) Aloe vera; e) Green tea; and f) resveratrol. In some embodiments, the composition comprises at least three juices. In some embodiments, the composition comprises at least four juices. In some embodiments, the composition comprises at least five juices. In some embodiments, the composition comprises at least six juices. In some embodiments, the composition comprises pomegranate juice, red grape juice, blueberry juice, black cherry juice, sour cherry juice, medlar juice, and brazil berry juice.

In some embodiments of the composition, the juice is a concentrated juice. In some embodiments of the composition, the soluble corn fiber is digestion resistant maltodextrin. In some embodiments, the composition further comprises carboxymethyl cellulose. In some embodiments, the composition further comprises xanthan gum.

The invention also relates to a composition comprising: a) About 30 units to about 1000 units of superoxide dismutase; b) About 50mg/mL to about 200mg/mL of soluble corn fiber; c) At least two concentrated juices selected from the group consisting of pomegranate juice, red grape juice, blueberry juice, black cherry juice, sour cherry juice, medlar juice, and brazil berry juice, each at about 5mg/mL to about 200 mg/mL; d) About 2mg/mL to about 20mg/mL of aloe vera concentrate; e) About 2mg/mL to about 20mg/mL of concentrated green tea; and f) from about 0.5mg/mL to about 6mg/mL resveratrol.

In some embodiments of the composition, the soluble corn fiber is digestion resistant maltodextrin. In some embodiments, the composition further comprises about 0.5mg/mL to about 5.0mg/mL of carboxymethyl cellulose. In some embodiments, the composition further comprises from about 0.5mg/mL to about 5.0mg/mL xanthan gum.

In an embodiment of any of the compositions disclosed herein, the composition has an Oxygen Radical Absorption Capacity (ORAC) of greater than 1000 μmol/g of the composition. In an embodiment of any of the compositions disclosed herein, the composition has an ORAC of greater than 1500 μmol/g composition. In an embodiment of any of the compositions disclosed herein, the ORAC value of the composition is at least 1.5 times higher than the sum of the ORAC values of each component of the composition alone. In an embodiment of any of the compositions disclosed herein, the ORAC value of the composition is at least 1.6 times higher than the sum of the ORAC values of each component of the composition alone.

The invention further relates to a method of reducing the number of oxygen radicals in a mammal comprising administering to the mammal any of the compositions disclosed herein. In some embodiments of the method, the reduced amount of oxygen radicals are peroxy radicals, hydroxy radicals, peroxynitrite, superoxide anions, singlet oxygen, hypochlorite, or a combination thereof.

The invention also relates to a method of reducing inflammation in a mammal comprising administering to the mammal any of the compositions disclosed herein.

The invention also relates to a method of alleviating a viral symptom in a mammal comprising administering to the mammal any of the compositions disclosed herein.

In embodiments of the methods disclosed herein, the composition is administered to the mammal once daily. In embodiments of the methods disclosed herein, the composition is administered to the mammal twice daily. In embodiments of the methods disclosed herein, the mammal is a human.

Drawings

FIG. 1 is a plot of viscosity (poise) versus shear rate (1/second) for two 5mL samples of the gel formulation of example 1 tested according to example 3, wherein the open circles represent sample 1; filled circles represent sample 2.

Detailed Description

The present invention provides compositions comprising superoxide dismutase and soluble fiber. The compositions disclosed herein can be used as supplements to increase the level of superoxide dismutase and soluble fiber in a subject. As described herein, the composition may also include additional components such as antioxidants, vitamins, or other nutrients, as well as excipients and other formulation ingredients.

It should be understood that the specific embodiments illustrated and described herein are examples and are not intended to limit the scope of the present application in any way.

The published patents, patent applications, websites, company names and scientific literature referred to herein are incorporated by reference in their entirety to the same extent as if each was specifically and individually indicated to be incorporated by reference. Any conflict with any references cited herein and with the specific teachings of this specification shall be resolved in favor of the latter. Also, any conflict between a definition of a word or phrase, as understood in the art, and a definition of the word or phrase, as specifically taught in this specification, shall be resolved in favor of the latter.

As used herein, "a" or "an" may refer to one or more. As used herein, when used in conjunction with the word "comprising," the "a" or "an" may refer to one or more than one. As used herein, "another" or "yet another" may refer to at least a second/species or more/species.

Throughout this application, the term "about" is used to denote a value that contains inherent differences in the error of the apparatus/method used to determine the value or differences present in the subject. Generally, the term "about" is meant to include about or less than 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19% or 20% variability, as the case may be.

The term "or" as used in the claims means "and/or" unless specifically indicated to the contrary, or the alternatives are mutually exclusive, but the disclosure supports definitions of alternatives and/or.

As used herein, the terms "comprises," comprising, "" including "(and any variant or form thereof, such as" comprises "and" containing ")," having, "" and any variant or form thereof, such as "contains" and "having," "including" (and any variant or form thereof, such as "contains" and "containing") or "containing" (and any variant or form thereof, such as "contains" and "containing") are inclusive or open-ended and do not exclude other unrecited elements or method steps.

The use of the term "e.g." and its corresponding abbreviation "such as" (whether italicized or not) means that the particular term cited is representative of examples and embodiments of the present disclosure and is not intended to be limited to the particular examples cited or referenced unless specifically indicated otherwise.

Unless defined otherwise, technical and scientific terms used herein have the meaning commonly understood by one of ordinary skill in the art to which this application belongs. Reference is made herein to various methods and materials known to those skilled in the art.

As used herein, the term "superoxide dismutase" (sometimes abbreviated SOD) refers to a catalytic superoxide anion radical (O) ₂ ^- ) Disproportionation into molecular oxygen and hydrogen peroxide (H) ₂ O ₂ ) Is an enzyme of (a). Superoxide dismutase has an Enzyme Class (EC) number of 1.15.1.1. Superoxide dismutase is an important component that protects cells from Reactive Oxygen Species (ROS), such as O formed during the metabolic process of the cells ^2- . Thus, superoxide dismutase, an important antioxidant, is present in almost all classesIn a cellular organism of the type. However, especially in complex organisms (e.g., mammals), superoxide dismutase levels in the cells decrease with age of the organism, making the organism more susceptible to cellular damage by reactive oxygen species.

As used herein, the term "soluble fiber" refers to any type of water-soluble dietary fiber. After consumption, the soluble fiber absorbs water and forms a gel in the intestinal tract of the organism, which helps to slow down the metabolism of lipids and carbohydrates. Soluble fiber is also a prebiotic that can be fermented by intestinal bacteria and helps maintain a healthy intestinal microbiota.

As used herein, the term "antioxidant" refers to a substance that significantly reduces the adverse effects of active substances such as reactive oxygen and nitrogen species by fully or partially neutralizing the active substance. Antioxidants can be classified as "primary antioxidants" and "secondary antioxidants". Primary antioxidants retard or inhibit the initial steps of oxidation, while secondary antioxidants slow oxidation by removing the substrate or by quenching oxygen radicals.

Superoxide dismutase and soluble fiber

In some embodiments, the compositions disclosed herein comprise superoxide dismutase in an amount measured in units of activity per mg protein. For enzyme activity, one unit (U) (in. Mu. Mol/min) is defined as the amount of enzyme that catalytically converts 1. Mu. Mol of substrate per minute under the specified conditions. The units of superoxide dismutase activity may be measured by any known method. For example, methods for determining superoxide dismutase activity in units can be found in McCord, J.M. and Fridovich, I., J.biol. Chem.1969,244:6049-6055; weydert et al, nature Protocols 2010,5 (1): 51-66; andhttps://www.sigmaaldrich.com/technical-documents/protocols/biology/ enzymatic-assay-of-superoxide-dismutase.htmltechnical protocol of (2); the respective disclosures of which are incorporated herein by reference. In some embodiments, the units of superoxide dismutase activity are defined as cells in a coupled system using xanthine and xanthine oxidase in a reaction volume of 3.0 milliliters at pH 7.8, 25 ℃The reduction rate of pigment c suppressed the amount of superoxide dismutase by 50%.

In some embodiments, the compositions disclosed herein comprise a high concentration of superoxide dismutase, e.g., greater than 0.5 units/mg, greater than 0.1 units/mg, greater than 1 unit/mg, greater than 10 units/mg, greater than 50 units/mg, greater than 100 units/mg, greater than 200 units/mg, greater than 500 units/mg, greater than 1000 units/mg, greater than 2000 units/mg, greater than 2500 units/mg, greater than 3000 units/mg, greater than 4000 units/mg, or greater than 5000 units/mg of superoxide dismutase and soluble fiber. In some embodiments, the compositions disclosed herein comprise from about 5 units/mg to about 5000 units/mg, from about 5 units/mg to about 4000 units/mg, from about 5 units/mg to about 3000 units/mg, or from about 5 units/mg to about 2000 units/mg of superoxide dismutase and soluble fiber. In some embodiments, the composition comprises from about 1 unit/mg to about 1000 units/mg, from about 1 unit/mg to about 750 units/mg, from about 1 unit/mg to about 500 units/mg, or from about 1 unit/mg to about 250 units/mg. In some embodiments, the compositions disclosed herein comprise about 0.5 units/mg to about 100 units/mg of the composition of superoxide dismutase and soluble fiber. In some embodiments, the composition comprises from about 1 unit/mg to about 50 units/mg of superoxide dismutase. In some embodiments, the composition comprises about 5 units/mg to about 25 units/mg of superoxide dismutase. In some embodiments, the composition comprises about 10 units/mg to about 15 units/mg of superoxide dismutase. In some embodiments, the composition comprises about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30 units/mg superoxide dismutase. In some embodiments, the composition comprises about 14 units/mg superoxide dismutase.

The superoxide dismutase used in the compositions disclosed herein can be obtained from any source of enzyme. In some embodiments, the superoxide dismutase is extracted from melon, bovine liver, heterotrophic bacteria, or marine phytoplankton. Superoxide dismutase may also be any type of enzyme. In some embodiments, the superoxide dismutase is copper/zinc superoxide dismutase, iron/manganese superoxide dismutase, or nickel superoxide dismutase.

In some embodiments, the superoxide dismutase is extracted from a plant. In some embodiments, the plant is a fruit, grain, or tuber. In some embodiments, the plant is a fruit selected from melon, citrus fruit, peach, pear, apple, or banana. In some embodiments, the plant is a cereal selected from the group consisting of wheat, barley, rye, millet, oat, spelt (spelt), barker (bulger), sorghum, and fargesia (farro). In some embodiments, the plant is a tuber selected from horseradish, potato, yam, sweet potato, tapioca, or dahlia.

In some embodiments, the superoxide dismutase is extracted from an animal. In some embodiments, the animal is a cow, pig, sheep, or goat.

In some embodiments, the superoxide dismutase is extracted from a microorganism. In some embodiments, the microorganism is a phytoplankton or a bacterium. In some embodiments, the microorganisms are heterotrophic bacteria, e.g., bacteria that extract the sugars required for energy production from their environment.

The ratio of superoxide dismutase to soluble fiber can be adjusted as desired by varying the amount of either or both components of the composition. In some embodiments, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:100 to about 1:1000. In some embodiments, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:200 to about 1:800. In some embodiments, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:300 to about 1:700. In some embodiments, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:500 to about 1:700. In some embodiments, the weight ratio of superoxide dismutase to soluble fiber in the composition is about 1:650 to about 1:675.

In some embodiments of the compositions disclosed herein, various types of soluble fibers may be used, including mixtures of two, three, four, five, six, or more different types of soluble fibers. In some embodiments, the soluble fiber is a water-soluble polysaccharide. In some embodiments, the soluble fiber is isolated from corn, wheat, barley, rye, beans, apples, pears, peaches, citrus fruits, berries, peas, rice bran, or oats. In some embodiments, the soluble fiber is selected from the group consisting of soluble corn fiber, inulin, dextrin, guar gum, oligosaccharides, galactose polysaccharide, fructo-oligosaccharides, lactulose, digestion-resistant starch, xylo-oligosaccharides, and isomalto-oligosaccharides. In some embodiments, the soluble fiber is soluble corn fiber. In some embodiments, the soluble fiber is digestion resistant maltodextrin. In some embodiments, the soluble fiber is Fibersol- . In some embodiments, the soluble fiber is Fibersol-/>Such as, for example, fiber sol-2AG, fiber sol-LQ, fiber sol-2L, fibersol-DLQ, or non-transgenic (non-GMO) fiber sol.

Powder composition

In some embodiments of the compositions disclosed herein, the compositions are in powder form. In embodiments where the composition is in powder form, it may be consumed in dry powder form or added to a beverage or foodstuff. In some embodiments, the powder is mixed into water, a hydrated beverage, a protein milkshake, a fruit juice, tea, coffee, milk, kefir (kefir), ice cream, yogurt, smoothies, broth, or soup prior to consumption.

In some embodiments, the powder composition comprises a high concentration of superoxide dismutase by weight, e.g., greater than 0.1ppm, greater than 0.5ppm, greater than 1ppm, greater than 2ppm, greater than 5ppm, greater than 10ppm, greater than 20ppm, greater than 50ppm, greater than 100ppm, greater than 200ppm, greater than 300ppm, greater than 400ppm, or greater than 500ppm. In some embodiments, the powder composition comprises from about 0.1ppm to about 10ppm by weight of superoxide dismutase. In some embodiments, the powder composition comprises from about 0.5ppm to about 5ppm by weight of superoxide dismutase. In some embodiments, the powder composition comprises from about 0.7ppm to about 2ppm by weight of superoxide dismutase. In some embodiments, the powder composition comprises from about 0.8ppm to about 1.2ppm by weight of superoxide dismutase. In some embodiments, the powder composition comprises about 0.1, 0.25, 0.5, 0.75, 1.0, 1.1, 1.2, 1.25, 1.3, 1.4, 1.5, 1.6, 1.7, 1.75, 1.8, 1.9, 2.0, 2.25, 2.5, 2.75, 3.0, 3.25, 3.5, 3.75, 4.0, 4.25, 4.5, 4.75, 5.0, 5.25, 5.5, 5.75, 6.0, 6.25, 6.5, 6.75, 7.0, 7.25, 7.5, 7.75, 8.0, 8.25, 8.5, 8.75, 9.0, 9.25, 9.5, 9.75, or 10.0ppm of superoxide dismutase by weight.

In some embodiments, the powder composition comprises from about 1% to about 90% by weight of soluble fiber. In some embodiments, the powder composition comprises from about 1% to about 50% by weight of soluble fiber. In some embodiments, the powder composition comprises from about 5% to about 25% by weight of soluble fiber. In some embodiments, the powder composition comprises from about 10% to about 20% by weight of soluble fiber. In some embodiments, the powder composition comprises from about 12% to about 14% by weight of soluble fiber. In some embodiments, the powder composition comprises about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29% or 30% by weight of soluble fiber.

Liquid or gel composition

In some embodiments of the compositions disclosed herein, the compositions are in the form of gels. In some embodiments of the compositions disclosed herein, the compositions are in liquid form. In embodiments where the composition is in gel or liquid form, it may be consumed directly in that form. In other embodiments, the gel or liquid may be added to a beverage or foodstuff. In some embodiments, the powder is mixed into water, a hydrated beverage, a protein milkshake, a fruit juice, tea, coffee, milk, kefir (kefir), ice cream, yogurt, smoothies, broth, or soup prior to consumption.

In some embodiments, the gel or liquid composition comprises about 0.005mg/mL to about 5.0mg/mL superoxide dismutase. In some embodiments, the gel or liquid composition comprises about 0.01mg/mL to about 2.5mg/mL of superoxide dismutase. In some embodiments, the gel or liquid composition comprises about 0.05mg/mL to about 1.0mg/mL superoxide dismutase. In some embodiments, the gel or liquid composition comprises about 0.1mg/mL to about 0.5mg/mL superoxide dismutase. In some embodiments, the gel or liquid composition comprises about 0.005, 0.01, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3.0mg/mL of superoxide dismutase.

In some embodiments, the gel or liquid composition comprises about 50mg/mL to about 1000mg/mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 70mg/mL to about 500mg/mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 90mg/mL to about 250mg/mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 100mg/mL to about 200mg/mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 50, 75, 100, 110, 120, 125, 130, 133, 135, 140, 150, 160, 170, 175, 180, 190, 200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450, 475, or 500mg/mL of the soluble fiber.

Fruit juice

In embodiments of the compositions disclosed herein, the composition comprising superoxide dismutase and soluble fiber further comprises fruit juice. The juice may provide additional antioxidants, soluble fiber, insoluble fiber, vitamins, and nutrients to the composition.

In some embodiments, the juice is a pomegranate juice, red grape juice, blueberry juice, black sweet cherry juice, sour cherry juice, medlar juice, brazil berry juice, blackberry juice, raspberry juice, strawberry juice, gooseberry juice, cranberry juice, orange juice, grapefruit juice, watermelon juice, beet juice, apple juice, lemon juice, lime juice, litchi juice, pineapple juice, prune juice, or a combination thereof. In some embodiments, the composition comprises two, three, four, five, or six types of fruit juices selected from: pomegranate juice, red grape juice, blueberry juice, black sweet cherry juice, sour cherry juice, medlar juice, brazil berry juice, blackberry juice, raspberry juice, strawberry juice, currant juice, cranberry juice, orange juice, grapefruit juice, watermelon juice, beet juice, apple juice, lemon juice, lime juice, litchi juice, pineapple juice and prune juice.

In some embodiments, the juice may be concentrated, e.g., to remove some of the water in the original juice. In some embodiments, the juice is a concentrated pomegranate juice, red grape juice, blueberry juice, black sweet cherry juice, sour cherry juice, medlar juice, brazil berry juice, blackberry juice, raspberry juice, strawberry juice, gooseberry juice, cranberry juice, orange juice, grapefruit juice, watermelon juice, beet juice, apple juice, lemon juice, lime juice, litchi juice, pineapple juice, prune juice, or a combination thereof. In some embodiments, the composition comprises two, three, four, five or six juice concentrates selected from: concentrated pomegranate juice, concentrated red grape juice, concentrated blueberry juice, concentrated black cherry juice, concentrated sour cherry juice, concentrated medlar juice, concentrated brazil berry juice, concentrated blackberry juice, concentrated raspberry juice, concentrated strawberry juice, concentrated currant juice, concentrated cranberry juice, concentrated orange juice, concentrated grapefruit juice, concentrated watermelon juice, concentrated beet juice, concentrated apple juice, concentrated lemon juice, concentrated lime juice, concentrated litchi juice, concentrated pineapple juice, and concentrated prune juice. In some embodiments, the concentrated juice removes about 60% to about 97% of the water in the juice. In some embodiments, the concentrated juice removes from about 85% to about 95% of the water in the juice. In some embodiments, the concentrated juice removes about 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% of the water in the juice. Any method known in the art for concentrating juice may be used to remove water from the juice.

In some embodiments, the composition comprises about 5mg/mL to about 200mg/mL of concentrated juice. In some embodiments, the composition comprises about 75mg/mL to about 150mg/mL of concentrated pomegranate juice. In some embodiments, the composition comprises about 75mg/mL to about 150mg/mL of concentrated red grape juice. In some embodiments, the composition comprises about 25mg/mL to about 100mg/mL of concentrated blueberry juice. In some embodiments, the composition comprises about 20mg/mL to about 80mg/mL of concentrated black cherry juice. In some embodiments, the composition comprises about 20mg/mL to about 80mg/mL of concentrated sour cherry juice. In some embodiments, the composition comprises about 2mg/mL to about 20mg/mL of concentrated medlar juice. In some embodiments, the composition comprises about 2mg/mL to about 20mg/mL of concentrated brazil juice.

Other additive components

In embodiments of the compositions disclosed herein, the composition comprising superoxide dismutase and soluble fiber further comprises aloe. Aloe may provide additional antioxidants, soluble fiber, insoluble fiber, vitamins, and nutrients to the composition.

In some embodiments, the aloe is aloe vera concentrate. In some embodiments, aloe may be concentrated, e.g., with some water removed from aloe extracted from aloe plants. In some embodiments, concentrating aloe removes about 60% to about 97% of the aloe moisture. In some embodiments, concentrating aloe removes about 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% of the aloe moisture. In some embodiments, the composition comprises about 2mg/mL to about 20mg/mL of aloe vera concentrate.

In embodiments of the compositions disclosed herein, the composition comprising superoxide dismutase and soluble fiber further comprises green tea. Green tea can provide additional antioxidants, vitamins and nutrients to the composition.

In some embodiments, the green tea is concentrated green tea. In some embodiments, the concentrated green tea is a green tea extract made from green tea leaves or green tea powder. In some embodiments, green tea is added to the composition in powder form. In some embodiments, the composition comprises from about 2mg/mL to about 20mg/mL of concentrated green tea.

In embodiments of the compositions disclosed herein, the composition comprising superoxide dismutase and soluble fiber further comprises resveratrol. Resveratrol may provide additional antioxidants to the composition. In some embodiments, the composition comprises from about 0.5mg/mL to about 6mg/mL resveratrol.

Excipient/formulation

In some embodiments, the compositions disclosed herein may be combined with one or more excipients. In some embodiments, the excipient is a gelling agent, thickener, carrier, buffer, or filler. In some embodiments, the compositions disclosed herein can be formulated into a beverage or food. In some embodiments, the composition is formulated as a juice, a hydrated beverage (e.g., sports beverage), a protein milkshake, tea, coffee, milk, kefir, ice cream, yogurt, smoothie, broth, or soup.

In some embodiments, the composition comprises a thickener/gellant carboxymethyl cellulose. In some embodiments, the composition is a gel comprising superoxide dismutase, soluble fiber, and carboxymethyl cellulose. In some embodiments, the composition comprises about 0.5mg/mL to about 5.0mg/mL of carboxymethyl cellulose.

In some embodiments, the composition comprises a thickener/gellant xanthan gum. In some embodiments, the composition is a gel comprising superoxide dismutase, soluble fiber, and xanthan gum. In some embodiments, the composition comprises about 0.5mg/mL to about 5.0mg/mL xanthan gum.

In some embodiments, the composition comprises: a) About 0.5 units/mg to about 100 units/mg superoxide dismutase; b) A soluble fiber; and c) at least two juices selected from the group consisting of pomegranate juice, red grape juice, blueberry juice, black cherry juice, sour cherry juice, medlar juice, and brazil berry juice. In some embodiments, the composition comprises at least three juices. In some embodiments, the composition comprises at least four juices. In some embodiments, the composition comprises at least five juices. In some embodiments, the composition comprises at least six juices. In some embodiments, the composition comprises pomegranate juice, red grape juice, blueberry juice, black cherry juice, sour cherry juice, medlar juice, and brazil berry juice. In some embodiments of the composition, the juice is a concentrated juice. In some embodiments of the composition, the soluble fiber is soluble corn fiber. In some embodiments, the soluble fiber is digestion resistant maltodextrin.

In some embodiments, the composition comprises: a) Superoxide dismutase; b) Soluble corn fiber; c) At least two juices selected from the group consisting of pomegranate juice, red grape juice, blueberry juice, black sweet cherry juice, sour cherry juice, medlar juice, and brazil berry juice; d) Aloe vera; e) Green tea; and f) resveratrol. In some embodiments, the composition comprises at least three juices. In some embodiments, the composition comprises at least four juices. In some embodiments, the composition comprises at least five juices. In some embodiments, the composition comprises at least six juices. In some embodiments, the composition comprises pomegranate juice, red grape juice, blueberry juice, black cherry juice, sour cherry juice, medlar juice, and brazil berry juice. In some embodiments of the composition, the juice is a concentrated juice. In some embodiments of the composition, the soluble corn fiber is digestion resistant maltodextrin. In some embodiments, the composition further comprises carboxymethyl cellulose. In some embodiments, the composition further comprises xanthan gum.

In some embodiments, the composition comprises: a) About 30 units to about 1000 units of superoxide dismutase; b) About 50mg/mL to about 200mg/mL of soluble corn fiber; c) At least two concentrated juices selected from the group consisting of pomegranate juice, red grape juice, blueberry juice, black cherry juice, sour cherry juice, medlar juice, and brazil berry juice, each at about 5mg/mL to about 200 mg/mL; d) About 2mg/mL to about 20mg/mL of aloe vera concentrate; e) About 2mg/mL to about 20mg/mL of concentrated green tea; and f) from about 0.5mg/mL to about 6mg/mL resveratrol. In some embodiments of the composition, the soluble corn fiber is digestion resistant maltodextrin. In some embodiments, the composition further comprises about 0.5mg/mL to about 5.0mg/mL of carboxymethyl cellulose. In some embodiments, the composition further comprises from about 0.5mg/mL to about 5.0mg/mL xanthan gum.

In some embodiments, the present invention provides a nutritional liquid formulation comprising soluble fiber and a plurality of antioxidants.

In some embodiments, the formulation comprises soluble corn fiber. The corn fiber may comprise about 1 to about 5 weight percent of the total formulation. The corn fiber may be in the form of a dry powder.

In some embodiments, the soluble fiber may be a corn-based digestion resistant maltodextrin (Fibersol-2) prebiotic fiber. Prebiotics are selectively fermented components that can undergo specific changes in the composition and/or activity of the intestinal microbiota, thereby bringing about health benefits.

In some embodiments, the antioxidants of the formulation include various polyphenols. The polyphenols may comprise about 1 to about 3% by weight of the total formulation. In some embodiments, the antioxidant of the formulation comprises superoxide dismutase (SOD).

In some embodiments, the present invention provides a nutritional supplement formulation comprising soluble corn fiber, concote red grape (grape Labrusca) juice concentrate, punica Granatum (Punica Granatum) juice concentrate, blueberry (Vaccinium Corymbosum) juice concentrate, black cherry (Prunus Avium) juice concentrate, sour cherry (Prunus Cerasus) juice concentrate, medlar (lyceum Barbarum) juice concentrate, brazil berry (Euterpe Oleraceae) berry juice concentrate, aloe juice concentrate (Aloe barbadensis Mill), green tea extract (Camellia Sinensis), resveratrol, melon juice concentrate (Cucumis melo L and extra-SOD).

The soluble fiber and antioxidant formulation of the present disclosure provide a synergistic effect because the soluble prebiotic fiber acts as a fertilizer for bacteria in the colon, while the majority of polyphenols are absorbed in the colon and are extensively catabolized by the colonic microbiota. The presence of the prebiotic fiber enhances the action of colonic microbiota, resulting in more efficient absorption of polyphenols in the colon. Most polyphenols from antioxidant supplements eventually enter the large intestine where they are metabolically converted to active metabolites by microorganisms, whereby they can exert antioxidant effects. Soluble fiber regulates intestinal microorganisms and maximizes polyphenol metabolism, producing a number of antioxidant, anti-inflammatory and anti-infective effects.

In some embodiments, the composition comprises the ingredients shown in table 1 in the amounts indicated.

TABLE 1

Reactive oxygen and oxygen radical absorption capacity

In some embodiments, the compositions disclosed herein can be used to reduce the level of Reactive Oxygen Species (ROS) in a cell. In some embodiments, the reduced level of active oxygen comprises one or more of peroxides, superoxides, hydroxyl radicals, singlet oxygen, and alpha-oxygen species. In some embodiments, the reduced level of active oxygen comprises one or more of peroxy radicals, hydroxy radicals, peroxynitrite, superoxide anions, singlet oxygen, or hypochlorite species.

The present invention provides the discovery that compositions comprising superoxide dismutase in combination with soluble fiber result in a substantial increase in Oxygen Radical Absorption Capacity (ORAC). The addition of soluble fiber to a composition comprising superoxide dismutase provides a synergistic effect of increasing the oxygen radical absorption capacity, i.e. the combined ORAC value is much greater than the sum of the uncombined superoxide dismutase and soluble fiber.

In some embodiments, the ability of a composition disclosed herein to reduce active oxygen levels in a cell is measured by measuring the Oxygen Radical Absorbance Capacity (ORAC) of the composition. Examples of ORAC assays are known in the art. See, for example, chapter 2-methods of measuring oxidative stress in the laboratory at pages 19-40 of "antioxidants in foods, vitamins and supplements" (Antioxidants in Food, vitamins and Supplements) (2014, elsevier) by dasgupta et al, "which is incorporated herein by reference.

Typically, the ORAC assay measures the antioxidant capacity of a substance. The ORAC assay measures the fluorescent signal from a probe that is quenched in the presence of active oxygen. An active oxygen inducer is introduced into the assay system. The inducer triggers the release of a particular reactive oxygen species, which degrades the probe and causes a change in the emission wavelength or intensity of the probe. The antioxidant material present in the assay absorbs active oxygen and prevents probe degradation. Thus, the extent to which the probe is preserved indicates the antioxidant capacity of the material.

In some embodiments, the fluorescent probe used in the ORAC assay is β -phycoerythrin or fluorescein. In some embodiments, the ORAC capacity of the antioxidant is measured compared to a standard. In some embodiments, the standard is a known antioxidant(6-hydroxy-2, 5,7, 8-tetramethyl chroman-2-carboxylic acid), which is a vitamin E analog. In useIn embodiments as a standard, the results may be expressed as the "total antioxidant capacity" (TAC) of the test molecule and as micromoles (μmol) of>Equivalent weight (TE).

In some embodiments, the ORAC assay measures one or more of active oxygen peroxy radicals, hydroxyl radicals, peroxynitrite, superoxide dismutase, singlet oxygen, and hypochlorite. In some embodiments, the ORAC assay is an ORAC 6.0 assay performed by Brunswick laboratories, shaosbur, massachusetts, usa. ORAC 6.0 assay tests antioxidant capacity against peroxy radicals, hydroxy radicals, peroxynitrite, superoxide dismutase, singlet oxygen and hypochlorite.

In an embodiment of any of the compositions disclosed herein, the composition has a total ORAC of greater than 1000 μmol/g composition. In an embodiment of any of the compositions disclosed herein, the composition has an ORAC of greater than 1500 μmol/g composition. In embodiments of any of the compositions disclosed herein, the composition has a total ORAC of greater than 700, 800, 900, 1000, 1100, 120, 1300, 1400, 1500, 1600, 1700, 1800, 1900, or 2000 μmol/g composition. As used herein, "total ORAC" refers to the sum of ORAC values for each active oxygen. For example, in an embodiment using an ORAC 6.0 assay, the total ORAC is the sum of ORAC values for each of peroxy radicals, hydroxyl radicals, peroxynitrite, superoxide dismutase, singlet oxygen, and hypochlorite. In some embodiments, the total ORAC value is divided by the weight of the composition in grams to give a value of μmol/g.

In an embodiment of any of the compositions disclosed herein, the ORAC value of the composition is at least 1.5 times higher than the sum of the ORAC values of each component of the composition alone. In an embodiment of any of the compositions disclosed herein, the ORAC value of the composition is at least 1.6 times higher than the sum of the ORAC values of each component of the composition alone. In embodiments of any of the compositions disclosed herein, the ORAC value of the composition is at least 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, or 2.5 times higher than the sum of the ORAC values of each component of the composition alone.

Viscosity of the mixture

In some embodiments, the compositions disclosed herein have viscosity characteristics that stabilize the composition. In some embodiments, the composition is a high viscosity gel that is shelf stable, retains its flavor over time, and allows minimal oxygen penetration into the composition. In some embodiments, the composition is thixotropic, has a high viscosity when stored and a lower viscosity when agitated, for example by shaking or application. In some embodiments, the composition is thixotropic and is a high viscosity gel with good stability characteristics upon storage, with lower viscosity upon administration to achieve ease of administration and uptake as well as advantageous distribution and good absorption in the gastrointestinal tract. In some embodiments, the composition has a viscosity of about 23 poise or greater at a shear rate of 1/second. In some embodiments, the composition has a viscosity of about 5 poise or less at a shear rate of 10 per second. In some embodiments, the composition has a viscosity of about 1 poise or less at a shear rate of 100 per second. In some embodiments, the composition has a viscosity of about 23 poise or greater at a shear rate of 1/second, a viscosity of about 5 poise or less at a shear rate of 10/second, and a viscosity of about 1 poise or less at a shear rate of 100/second.

Method

The invention also relates to a method of reducing the number of oxygen radicals in a mammal comprising administering to the mammal any of the compositions disclosed herein. In some embodiments, the reduced amount of oxygen radicals is selected from: peroxy radicals, hydroxy radicals, peroxynitrite, superoxide anions, singlet oxygen, hypochlorite, or combinations thereof. In some embodiments, the method may reduce two, three, four, five, or six types of oxygen radicals. In some embodiments, the reduced amount of oxygen radicals is selected from the group consisting of peroxy radicals, hydroxyl radicals, peroxynitrite, superoxide anions, singlet oxygen, and hypochlorite in the mammal.

In some embodiments, the synergistic effect observed with the superoxide dismutase/soluble fiber combination provides increased Oxygen Radical Absorption Capacity (ORAC), which is beneficial for reducing inflammation. The invention also relates to a method of reducing inflammation in a mammal comprising administering to the mammal any of the compositions disclosed herein. The invention also relates to methods of treating any disease or disorder associated with increased reactive oxygen species in a mammal comprising administering to the mammal any of the compositions disclosed herein. In some embodiments, the disease or disorder may be a bacterial infection; viral infection; radiation sickness; demyelinating diseases such as multiple sclerosis or neuropathy; joint diseases such as arthritis, rheumatoid arthritis or psoriatic arthritis; skin diseases such as psoriasis, rosacea, acne vulgaris, dermatitis or urticaria; neurodegenerative diseases such as multiple sclerosis, parkinson's disease, amyotrophic lateral sclerosis, alzheimer's disease or huntington's disease; neuromuscular diseases, such as muscular dystrophy, myasthenia gravis; tremor; intestinal diseases such as inflammation of the digestive tract, inflammatory bowel disease, crohn's disease, colitis, diarrhea, leaky bowel syndrome, diverticulitis or celiac disease; asthma; inflammatory diseases such as autoimmune diseases, diabetes, gout, chronic prostatitis, glomerulonephritis, suppurative sweat gland inflammation, interstitial cystitis, lichen planus, mast cell activation syndrome, mastocytosis, otitis media, pelvic inflammatory disease; reperfusion injury; chronic fatigue syndrome; rheumatic fever; rhinitis; sarcoidosis; transplant rejection; and vasculitis.

In some embodiments, the synergistic effect observed with the superoxide dismutase/soluble fiber combination provides increased Oxygen Radical Absorption Capacity (ORAC), which is beneficial in the prevention and treatment of viral infections. In some embodiments, the compositions disclosed herein are useful in methods of preventing viral infection, including influenza a, influenza b, influenza c, influenza d, coronaviruses including SARS (severe acute respiratory syndrome), SARS-CoV-2 (causing covd-19), MERS (middle east respiratory syndrome), HIV, ebola, rhinoviruses, and respiratory syncytial viruses. In some embodiments, the compositions disclosed herein are useful in methods of treating viral infections, including influenza a, influenza b, influenza c, influenza d, coronaviruses including SARS (severe acute respiratory syndrome), SARS-CoV-2 (causing covd-19), MERS (middle east respiratory syndrome), HIV, ebola, rhinoviruses, and respiratory syncytial viruses.

In some embodiments, the synergistic effect observed with the superoxide dismutase/soluble fiber combination provides an increased Oxygen Radical Absorption Capacity (ORAC), which facilitates supplementation of the diet of subjects receiving cancer treatment. In some embodiments, the compositions disclosed herein are useful in methods of supplementing the diet of a mammal undergoing cancer treatment, having been exposed to radiation, or suffering from malnutrition.

In an embodiment of any of the methods disclosed herein, the composition is administered to the mammal once daily. In an embodiment of any of the methods disclosed herein, the composition is administered to the mammal twice daily. In embodiments of any of the methods disclosed herein, the composition is administered to the mammal three, four, five, six, seven, eight, nine, ten or more times per day.

In embodiments of the methods disclosed herein, the mammal is a human. In any of the embodiments of the methods disclosed herein, the mammal is a primate (e.g., monkey, ape, gorilla, macaque), a domestic animal (e.g., dog, cat, rabbit, hamster, guinea pig, mouse, rat), or an agricultural animal (e.g., cow, sheep, horse, goat, pig).

Examples

Example 1: exemplary formulations

Exemplary formulations were prepared having the ingredients and concentrations shown in table 2:

TABLE 2

SI.#	Composition of the components	QTY，mg
			1	Soluble corn fiber (fiber sol-2)	4000
2	Concentrated juice of pomegranate	4000
			3	Conkede grape concentrated juice	4000
4	Blueberry concentrated juice	2000
			5	Concentrated black cherry juice	1450
6	Sour cherry concentrated juice	1450
			7	Lycium chinense juice	294
8	Brazil berry concentrated juice	200
			9	Aloe juice	200
10	Green tea extract	200
			11	Resveratrol	80
12	Extramel SOD (14000 unit/g)	6
			13	CMC	60.5
14	Xanthan gum	60.5
			15	QS Water (30 ml)

Ingredients 1-12 were mixed into a homogeneous mixture using a stainless steel mixing tank. The ingredients were weighed according to batch size prior to mixing. The juice concentrate is first thoroughly mixed in a separate tank, then the solid components are premixed with water in a separate mixer, and the two mixtures are mixed in a main mixing tank. Sufficient water is added and the product is mixed properly. The final product is pasteurized before being packaged in a bag. The preparation is a gel with deep red color.

Example 2: ORAC test of exemplary formulations

Tests were performed to determine ORAC values for the different components of the formulation of example 1 compared to the entire formulation. Individual component samples were prepared using the amount (by weight) of sample in the total formulation: sample a:4g of soluble corn fiber (fiber sol-) The method comprises the steps of carrying out a first treatment on the surface of the Sample B:13.8749g of concentrated juice mixture; sample C: 0.006g of superoxide dismutase isolated from melon. Sample D is a final product formulation weighing 31.1 g. Samples were sent to the Brunswick laboratory (shaosburer, massachusetts, usa) using the methods described above andhttps://brunswicklabs.com/capabilities/bioanalytical-services/ orac-family/orac6/the ORAC 6.0 assay was tested. The assay results are provided in table 3, "test results" are expressed as micromole Trilox equivalents per gram of test sample. The "transform" column provides a transform of the ORAC value normalized for the sample size. / >

As can be seen from table 3, the final product sample D showed an unexpectedly and significantly higher ORAC value (48,021.79) than the sum of the individual component samples a-C (29,094.26). Thus, the ORAC test showed a synergistic effect between the components of the formulation of example 1 when these components were combined. Without wishing to be bound by theory, one potential contribution to this synergistic effect is the possible stabilizing effect that other components have on superoxide dismutase, allowing the superoxide dismutase to neutralize active oxygen more effectively.

Example 3: viscosity testing of exemplary formulations

The formulation of example 1 was tested for viscosity under different shear stresses. 5mL of the formulation gel was tested using a dynamic viscometer at a temperature of 25 ℃. The viscosities (in poise) of two separate samples of formulation gel were tested at increasing shear stress and shear rate over time, as shown in tables 4 and 5. The normal stress at each time point is also shown.

Shear stress	Shear rate	Viscosity of the mixture	Time	Temperature (temperature)	Normal stress
						dyne/cm^2	1/second	Poise and park	Second of	℃	dyne/cm^2
9.156	0.09999	91.56	60.5	25	-5804
						12.02	0.1585	75.81	125.53	25	-6041
14.58	0.2512	58.05	190.5	25	-6266
						17.35	0.3981	43.57	255.53	25	-6536
20.42	0.631	32.36	320.52	25	-6686
						23.85	1	23.85	385.5	25	-6706
27.66	1.585	17.45	450.55	25	-6558
						32.03	2.512	12.75	515.58	25	-6370
37.1	3.981	9.32	580.52	25	-6290
						43.19	6.31	6.845	645.53	25	-6199
50.68	10	5.068	710.53	25	-6252
						60.15	15.85	3.795	775.53	25	-6420
71.93	25.12	2.863	840.52	25	-6842
						87.02	39.81	2.186	905.53	25	-7154
106.8	63.1	1.693	970.52	25	-7429
						133.1	100	1.331	1035.5	25	-7560
167.9	158.5	1.059	1100.5	25	-7728
						213.8	251.2	0.851	1165.5	25	-7875
280.2	398.1	0.7039	1230.5	25	-8092
						374.8	631	0.5941	1295.5	25	-8536
509	1000	0.509	1360.5	25	-9372

Table 4-viscosity of gel formulation sample 1 (5 mL) at increased shear stress.

Shear stress	Shear rate	Viscosity of the mixture	Time	Temperature (temperature)	Normal stress
						dyne/cm^2	1/second	Poise and park	Second of	℃	dyne/cm^2
9.444	0.1	94.42	60.984	25	-2232
						13.28	0.1585	83.8	125.97	25	-2797
16.31	0.2512	64.92	190.92	25	-3238
						18.74	0.3981	47.07	255.95	25	-3653
21.27	0.631	33.71	320.95	25	-4024
						24.37	1	24.37	385.92	25	-4395
28.04	1.585	17.69	450.94	25	-4734
						32.16	2.512	12.8	515.92	25	-5045
36.82	3.981	9.25	580.94	25	-5344
						42.17	6.31	6.684	645.98	25	-5693
48.37	10	4.837	710.92	25	-5939
						55.84	15.85	3.523	775.95	25	-6198
65.62	25.12	2.613	840.98	25	-6154
						78.27	39.81	1.966	905.97	25	-6107
94.9	63.1	1.504	970.94	25	-6040
						117	100	1.17	1036	25	-5768
147.5	158.5	0.9309	1101	25	-5671
						188.4	251.2	0.7502	1166	25	-5826
249.1	398.1	0.6256	1231	25	-6237
						330.8	631	0.5244	1295.9	25	-6803
445.3	1000	0.4453	1361	25	-7822

Table 5-viscosity of gel formulation sample 2 (5 mL) at increased shear stress.

The results provided in tables 4 and 5 are plotted in figure 1. As can be seen from tables 4 and 5 and fig. 1, the gel formulation surprisingly has thixotropic properties, which become less viscous when shear stress is applied. This thixotropic property may provide several advantages to the gel formulation. In the resting state, the gel formulation is a high viscosity gel that helps the product maintain its physical composition, maintains its flavor, and minimizes oxygen permeation. During administration, the gel formulation is agitated to reduce its viscosity, which results in increased flowability to facilitate oral administration, while also facilitating distribution of the formulation in the gastrointestinal tract, thereby facilitating absorption.

Example 4: improving rehabilitation of covd-19 patients

Theoretically, the superoxide dismutase and soluble fiber compositions described herein help to enhance the immune system, make subjects taking the compositions more resistant to and also better recover more quickly from viral or bacterial infections. Thus, the gel formulation of example 1 was administered to several patients who detected a positive for COVID-19, a disease caused by the Sars-CoV-2 virus. Current signs of medical professionals and researchers indicate that recovery from covd-19 may take up to two weeks. Each patient receiving the gel formulation, regardless of age or sex, was able to recover faster than expected.

Patient 1 was a male between ages 41-50 who tested positive for covd-19 and was associated with fever, cough and taste loss. Five days after the test was positive, he began taking the gel formulation twice daily. Patient 1 reported a feeling of well-being, a reduction in fatigue, and an abundance within three to four days of starting to take the gel formulation.

Patient 2 was a 18-20 year old female with a positive detection of covd-19 with fever, coughing and headache. She began taking the gel formulation once a day on the day that the test was positive. Patient 2 reported a feeling much better, more active, and less tired within three to four days of starting to take the gel formulation.

Patient 3 was a 31-40 year old male whose covd-19 detected positive with fever, cough and headache, while feeling very weak. Four days after the test was positive, he began taking the gel formulation once or twice a day. Within two days of starting to take the gel formulation, patient 3 reported that he felt much better, no longer felt weak, and was energetic.

Patient 4 was a 61-70 year old female, and was hospitalized with covd-19 detected positive and symptoms due to fever, cough, headache, and loss of taste. Five days after the test was positive, she began taking the gel formulation once per day. Within three to four days, she felt more energetic and had reduced fatigue.

Patient 5 was a 20-30 year old male whose covd-19 detected positive with fever, cough and headache. Three days after the test was positive, he began taking the gel formulation once per day. In two to four days, he felt much more, felt energetic, and not so tired.

Example 5: improving fatigue associated with diabetes

The patient was a middle-aged female and was recently diagnosed with diabetes. Even with careful diet, she experiences extreme fatigue and A1C levels as high as 10.2%. She began to take the gel formulation of example 1 and at the end of the first day of taking she began to feel full. Three days after taking the gel formulation, she reported that the energy "exceeded the level of the most crazy dream".

Example 6: improving myasthenia gravis symptoms

The patient was a 35-45 year old female with a rare muscular dystrophy, called myasthenia gravis. This disease affects almost her entire musculature, including her breathing, walking, speaking, swallowing, and eye movement. 7 months 2019, she needs to use a wheelchair for hospitalization. She cannot walk more than a few feet and breathe hard. Prednisone is treated for its symptoms at a daily dose of 40 mg. She began taking the gel formulation of example 1 once a day and the powdered superoxide dismutase/soluble fiber formulation as described herein once a day. Three days later she began to feel that her own symptoms were improved and more energetic. After taking this combination of gel and powder formulation for several months, she now took only 5 mg of prednisone per day, and was physically active and able to walk for long distances. She no longer had problems with swallowing or speaking, nor with eye movement.

Example 7: improving symptoms of multiple sclerosis

The patient was a female, aged between 35-45 years, with multiple sclerosis. Her symptoms initially began on her legs, but later developed to her right arm. She frequently feels pain, extreme fatigue, and sleep is also problematic. She began taking the gel formulation of example 1 and soon after that her right arm was able to move, with reduced pain. After taking the product for several months, her pain and fatigue are reduced, and sleep is better. She was able to reduce the amount of medication taken and walk from only about 3,500 steps per day to 11,000 steps per day.

Example 8: improving gout symptoms

The patient is a gout male aged 40-50 years. He initially began taking the gel formulation of example 1 as a recovery supplement after exercise and noted an improvement in his symptoms after one month. When his gout was onset, he took the gel formulation of example 1 twice a day, after which his symptoms were controlled.

Example 9: improving recovery of viral symptoms

The patient was a female with viral symptoms including dyspnea and loss of taste. She received the detection of covd-19, but the result was negative. She took the gel formulation of example 1 twice daily. After three days, she felt much better and after five days had no viral symptoms.

It will be apparent to those of ordinary skill in the relevant art that other suitable modifications and adaptations to the methods and applications described herein may be made without departing from the scope of any embodiment. The above embodiments are included herein for illustrative purposes only and are not intended to be limiting.

It is to be understood that while certain embodiments have been illustrated and described herein, the claims are not limited to the specific forms or arrangements of parts so described and illustrated. In the specification, illustrative embodiments have been disclosed and, although specific terms are employed, they are used in a generic and descriptive sense only and not for purposes of limitation. Modifications and variations of the embodiments are possible in light of the above teachings. It is, therefore, to be understood that the embodiments may be practiced otherwise than as specifically described.

While various embodiments have been described above, it should be understood that they have been presented by way of illustration and example only, and not limitation. It will be apparent to persons skilled in the relevant art that various modifications and changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present technology should not be limited by any of the above-described embodiments, but should be defined only in accordance with the following claims and their equivalents. It will also be appreciated that features of embodiments of the references described and cited herein may be used in combination with features of any other embodiment. All patents and publications cited herein are incorporated by reference in their entirety.

Claims (13)

1. A composition comprising:

a) 0.1 mg/mL to 0.5 mg/mL superoxide dismutase;

b) 100 mg to 200 mg/mL of a soluble prebiotic fiber selected from the group consisting of soluble corn fiber, inulin, guar gum, galactose polysaccharide, fructooligosaccharides, lactulose, resistant starch, xylooligosaccharides and isomalto-oligosaccharides; and

c) At least two juices selected from the group consisting of: 75 mg/mL to 150 mg/mL of concentrated pomegranate juice, 75 mg/mL to 150 mg/mL of concentrated red grape juice, 25 mg/mL to 100 mg/mL of concentrated blueberry juice, 20mg/mL to 80 mg/mL of concentrated black cherry juice, 20mg/mL to 80 mg/mL of concentrated sour cherry juice, 2mg/mL to 20mg/mL of concentrated medlar juice, and 2mg/mL to 20mg/mL of concentrated brazil juice;

the composition further comprises 2mg/mL to 20mg/mL of concentrated aloe, 2mg/mL to 20mg/mL of concentrated green tea, and 0.5 mg/mL to 6 mg/mL of resveratrol;

wherein the composition is in the form of a gel.

2. The composition of claim 1, wherein the superoxide dismutase is extracted from melon, bovine liver, heterotrophic bacteria, or marine phytoplankton.

3. The composition of claim 1, wherein the superoxide dismutase is copper/zinc superoxide dismutase, iron/manganese superoxide dismutase, or nickel superoxide dismutase.

4. The composition of claim 1, wherein the superoxide dismutase is extracted from an animal.

5. The composition of claim 4 wherein the animal is a cow, pig, sheep or goat.

6. The composition of claim 1, wherein the weight ratio of superoxide dismutase to soluble prebiotic fiber is from 1:500 to 1:700.

7. The composition of claim 1, wherein the soluble prebiotic fiber is a soluble corn fiber.

8. The composition of claim 7, wherein the soluble corn fiber is digestion resistant maltodextrin.

9. The composition of claim 1, wherein the juice is a concentrated juice with 60% to 97% of the water removed from the juice.

10. The composition of claim 1, wherein the composition further comprises carboxymethyl cellulose.

11. The composition of claim 1, wherein the composition further comprises xanthan gum.

12. The composition of claim 1, wherein the composition has an oxygen radical absorption capacity greater than 1000 μmol/g composition.

13. The composition of claim 1, wherein the oxygen radical absorbance capacity value of the composition is at least 1.5 times higher than the sum of the individual oxygen radical absorbance capacity values of each component of the composition.