Superoxide dismutase-soluble fiber composition

Abstract

The present disclosure relates generally to compositions comprising superoxide dismutase and soluble fiber. The composition can be used as a dietary supplement and for health and wellbeing.SOLUTION: A composition comprising superoxide dismutase and soluble fibre is provided. The composition may further comprise other antioxidants, vitamins, and nutrients. The composition can be used as a dietary supplement and for improving health and wellbeing.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present disclosure relates generally to compositions comprising superoxide dismutase and soluble fiber, which can be used as dietary supplements and for health and well-being. [Background technology]

[0002] Superoxide dismutase (SOD) is a group of metalloenzymes that protect cells from damage caused by reactive oxygen species (ROS). SOD is a catabolic enzyme that converts the superoxide anion free radical (O2 - ROS catalyze the dismutation of ROS into molecular oxygen and hydrogen peroxide (HO). ROS in cells can damage nucleic acids, proteins, and lipids, impairing cellular function and possibly leading to apoptosis. Therefore, the ability to convert ROS into harmless molecules is crucial for protecting cellular function and overall health.

[0003] Almost all living organisms naturally produce some types of SOD, but the level of SOD produced in cells decreases as a subject ages or when a subject suffers from certain health disorders.In addition, the presence of various pollutants and toxins in the environment can also cause an increase in the level of ROS in cells.Therefore, nutritional supplementation of naturally produced SOD may be important for maintaining health.

[0004] Another important nutritional component is soluble fiber. Soluble fiber absorbs water and forms a gel in the digestive tract. Soluble fiber has many benefits for the intestine, including slowing down the digestion of certain types of lipids and carbohydrates, helping to prevent the uptake of dietary cholesterol, and preventing spikes in blood sugar levels. Soluble fiber is also important for maintaining a healthy intestinal microflora, as intestinal bacteria can ferment some types of soluble fiber. Modern diets are typically low in soluble fiber, often requiring supplements to improve health.

[0005] Diabetes mellitus (diabetes) is a common disorder of carbohydrate metabolism. In the United States, over 30 million people have diabetes. In the past 20 years, as the American population has aged and become overweight or obese, the number of adults diagnosed with diabetes has more than tripled. In people with diabetes, the body's normal ability to utilize glucose is impaired, leading to high blood sugar levels. Diabetes is associated with a high risk of cardiovascular or circulatory system disease or disorders.

[0006] Fiber, including soluble fiber in foods, has been shown to blunt the glycemic response to a meal. When fermented by gut bacteria, fiber also produces short-chain fatty acid [SCFA] metabolites that are involved in glucose homeostasis. However, high-fiber foods can cause gastric discomfort, as can certain fiber supplements.

[0007] Antioxidants have been shown to exert beneficial effects on the human body in combating free radicals involved in many disease processes. However, the absorption of effective metabolites of many antioxidants, such as polyphenols, depends on microbial metabolism of the antioxidants in the intestine. Therefore, many dietary supplements do not produce these effective polyphenol metabolites, limiting the antioxidant activity of the supplements. [Prior art documents] [Non-patent literature]

[0008] [Non-Patent Document 1] McCord, JM and Fridovich, I., J. Biol. Chem. 1969, 244:6049-6055 [Non-patent document 2] Weydert et al., Nature Protocols 2010, 5(1): 51-66 [Non-patent document 3] Technical protocol at https: / / www.sigmaaldrich.com / technical-documents / protocols / biology / enzymatic-assay-of-superoxide-dismutase.htm [Non-patent document 4] "Chapter 2- Methods for Measuring Oxidative Stress in the Laboratory", A. Dasgupta et al., pp. 19-40, Antioxidants in Food, Vitamins and Supplements (2014, Elsevier) Summary of the Invention [Means for solving the problem]

[0009] The present disclosure is directed to compositions comprising about 0.5 units / mg to about 500 units / mg of superoxide dismutase and soluble fiber. In some embodiments of the present disclosure, the composition comprises about 1 unit / mg to about 100 units / mg of superoxide dismutase. In some embodiments of the present disclosure, the composition comprises about 5 units / mg to about 50 units / mg of superoxide dismutase. In some embodiments of the present disclosure, the composition comprises about 10 units / mg to about 15 units / mg of superoxide dismutase. In some embodiments of the present disclosure, the composition comprises about 14 units / mg of superoxide dismutase.

[0010] In some embodiments of the present disclosure, the superoxide dismutase in the composition is extracted from melon, beef liver, heterotrophic bacteria, or marine phytoplankton. In some embodiments of the present disclosure, the superoxide dismutase is copper / zinc superoxide dismutase, iron / manganese superoxide dismutase, or nickel superoxide dismutase.

[0011] In some embodiments of the present disclosure, the superoxide dismutase in the composition is extracted from a plant. In some embodiments, the plant is a fruit, a grain, or a tuber. In some embodiments, the plant is a fruit selected from melon, citrus, peach, pear, apple, or banana. In some embodiments, the plant is a grain selected from wheat, barley, rye, millet, oat, spelt, bulgur, sorghum, and emmer wheat. In some embodiments, the plant is a tuber selected from horseradish, potato, yam, sweet potato, cassava, or dahlia.

[0012] In some embodiments of the present disclosure, the superoxide dismutase in the composition is extracted from an animal, hi some embodiments, the animal is a cow, a pig, a sheep, or a goat.

[0013] In some embodiments of the present disclosure, the superoxide dismutase in the composition is extracted from a microorganism, hi some embodiments, the microorganism is a phytoplankton or a bacterium.

[0014] In some embodiments of the present disclosure, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:100 to about 1:1000 by mass. In some embodiments of the present disclosure, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:200 to about 1:800 by mass. In some embodiments of the present disclosure, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:300 to about 1:700 by mass. In some embodiments of the present disclosure, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:500 to about 1:700 by mass. In some embodiments of the present disclosure, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:650 to 1:675 by mass.

[0015] In some embodiments of the present disclosure, the soluble fiber in the composition is a water-soluble polysaccharide. In some embodiments of the present disclosure, 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 present disclosure, the soluble fiber in the composition is selected from soluble corn fiber, inulin, dextrin, guar gum, oligopolysaccharides, galactopolysaccharides, fructooligosaccharides, lactulose, resistant starch, xylooligosaccharides, and isomero-oligosaccharides. In some embodiments of the present disclosure, the soluble fiber in the composition is soluble corn fiber. In some embodiments of the present disclosure, the soluble fiber in the composition is resistant maltodextrin.

[0016] In some embodiments of the present disclosure, the composition is in the form of a powder. In some embodiments, the powder composition comprises about 0.1 ppm to about 10 ppm by weight of superoxide dismutase. In some embodiments, the powder composition comprises about 0.5 ppm to about 5 ppm by mass of superoxide dismutase. In some embodiments, the powder composition comprises about 0.7 ppm to about 2 ppm by mass of superoxide dismutase. In some embodiments, the powder composition comprises about 0.8 ppm to about 1.2 ppm by mass of superoxide dismutase. In some embodiments, the powder composition comprises about 1% to about 90% by mass of soluble fiber. In some embodiments, the powder composition comprises about 1% to about 50% by mass of soluble fiber. In some embodiments, the powder composition comprises about 5% to about 25% by mass of soluble fiber. In some embodiments, the powder composition comprises about 10% to about 20% by mass of soluble fiber. In some embodiments, the powder composition comprises about 12% to about 14% soluble fiber by mass.

[0017] In some embodiments of the present disclosure, the composition is in the form of a gel. In some embodiments of the present disclosure, the composition is in the form of a liquid. In some embodiments, the gel or liquid composition comprises from about 0.005 mg / mL to about 3.0 mg / mL of superoxide dismutase. In some embodiments, the gel or liquid composition comprises from about 0.01 mg / mL to about 2.0 mg / mL of superoxide dismutase. In some embodiments, the gel or liquid composition comprises from about 0.05 mg / mL to about 1.0 mg / mL of superoxide dismutase. In some embodiments, the gel or liquid composition comprises from about 0.1 mg / mL to about 0.5 mg / mL of superoxide dismutase.

[0018] In some embodiments, the gel or liquid composition comprises about 50 mg / mL to about 1000 mg / mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 70 mg / mL to about 500 mg / mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 90 mg / mL to about 250 mg / mL of soluble fiber. In some embodiments, the gel or liquid composition comprises about 100 mg / mL to about 200 mg / mL of soluble fiber.

[0019] In some embodiments of the present disclosure, the composition comprising superoxide dismutase and soluble fiber also comprises fruit juice. In some embodiments, the fruit juice is pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, acai 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, lychee juice, pineapple juice, prune juice, or a combination thereof. In some embodiments, the fruit juice is concentrated pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, acai 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, lychee juice, pineapple juice, prune juice, or a combination thereof. In some embodiments, the concentrated fruit juice has about 60% to about 97% of the water removed from the juice. In some embodiments, the concentrated fruit juice has about 85% to about 95% of the water removed from the juice. In some embodiments, the composition comprises about 5 mg / mL to about 200 mg / mL of concentrated fruit juice. In some embodiments, the composition comprises about 75 mg / mL to about 150 mg / mL of concentrated pomegranate juice. In some embodiments, the composition comprises about 75 mg / mL to about 150 mg / mL of concentrated red grape juice. In some embodiments, the composition comprises about 25 mg / mL to about 100 mg / mL of concentrated blueberry juice. In some embodiments, the composition comprises about 20 mg / mL to about 80 mg / mL of concentrated dark sweet cherry juice. In some embodiments, the composition comprises about 20 mg / mL to about 80 mg / mL of concentrated sour cherry juice. In some embodiments, the composition comprises about 2 mg / mL to about 20 mg / mL of concentrated goji berry juice.In some embodiments, the composition comprises about 2 mg / mL to about 20 mg / mL of concentrated acai berry juice.

[0020] In some embodiments of the present disclosure, the composition comprising superoxide dismutase and soluble fiber also comprises aloe vera. In some embodiments, the aloe vera is concentrated aloe vera. In some embodiments, the concentrated aloe vera has about 60% to about 97% of the water removed from the aloe vera. In some embodiments, the composition comprises about 2 mg / mL to about 20 mg / mL of concentrated aloe vera.

[0021] In some embodiments of the present disclosure, the composition comprising superoxide dismutase and soluble fiber also 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 about 2 mg / mL to about 20 mg / mL of concentrated green tea.

[0022] In some embodiments of the present disclosure, the composition comprising superoxide dismutase and soluble fiber also comprises resveratrol, hi some embodiments, the composition comprises about 0.5 mg / mL to about 6 mg / mL of resveratrol.

[0023] In some embodiments of the present disclosure, the gel composition comprising superoxide dismutase and soluble fiber also comprises carboxymethylcellulose, hi some embodiments, the composition comprises about 0.5 to about 5.0 mg / mL of carboxymethylcellulose.

[0024] In some embodiments of the present disclosure, the gel composition comprising superoxide dismutase and soluble fiber also comprises xanthan gum, hi some embodiments, the composition comprises about 0.5 to about 5.0 mg / mL of xanthan gum.

[0025] The present disclosure is also directed to compositions comprising: a) about 0.5 units / mg to about 100 units / mg of superoxide dismutase; b) soluble fiber; and c) at least two fruit juices selected from pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice. In some embodiments, the compositions comprise at least three fruit juices. In some embodiments, the compositions comprise at least four fruit juices. In some embodiments, the compositions comprise at least five fruit juices. In some embodiments, the compositions comprise at least six fruit juices. In some embodiments, the compositions comprise pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice.

[0026] In some embodiments of the composition, the fruit juice is a fruit juice concentrate. In some embodiments of the composition, the soluble fiber is a soluble corn fiber. In some embodiments, the soluble corn fiber is a resistant maltodextrin.

[0027] The present disclosure is also directed to a composition comprising: a) superoxide dismutase; b) soluble corn fiber; c) at least two fruit juices selected from pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice; d) aloe vera; e) green tea; and f) resveratrol. In some embodiments, the composition comprises at least three fruit juices. In some embodiments, the composition comprises at least four fruit juices. In some embodiments, the composition comprises at least five fruit juices. In some embodiments, the composition comprises at least six fruit juices. In some embodiments, the composition comprises pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice.

[0028] In some embodiments of the composition, the fruit juice is a concentrated fruit juice. In some embodiments of the composition, the soluble corn fiber is a resistant maltodextrin. In some embodiments, the composition also includes carboxymethylcellulose. In some embodiments, the composition also includes xanthan gum.

[0029] The present disclosure is also directed to a composition comprising: a) about 30 units to about 1000 units of superoxide dismutase; b) about 50 mg / mL to about 200 mg / mL of soluble corn fiber; c) about 5 mg / mL to about 200 mg / mL of each of at least two fruit juice concentrates selected from pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice; d) about 2 mg / mL to about 20 mg / mL of concentrated aloe vera; e) about 2 mg / mL to about 20 mg / mL of concentrated green tea; and f) about 0.5 mg / mL to about 6 mg / mL of resveratrol.

[0030] In some embodiments of the composition, the soluble corn fiber is resistant maltodextrin. In some embodiments, the composition also includes about 0.5 to about 5.0 mg / mL of carboxymethylcellulose. In some embodiments, the composition also includes about 0.5 to about 5.0 mg / mL of xanthan gum.

[0031] In any embodiment of the compositions disclosed herein, the composition has an oxygen radical absorbance capacity (ORAC) greater than 1000 μmol / g composition. In any embodiment of the compositions disclosed herein, the composition has an ORAC greater than 1500 μmol / g composition. In any embodiment of the compositions disclosed herein, the ORAC value for the composition is at least 1.5 times higher than the sum of the individual ORAC values ​​for each component of the composition. In any embodiment of the compositions disclosed herein, the ORAC value for the composition is at least 1.6 times higher than the sum of the individual ORAC values ​​for each component of the composition.

[0032] The present disclosure is further directed 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 free oxygen radicals whose number is reduced are peroxy radicals, hydroxyl radicals, peroxynitrite, superoxide anions, singlet oxygen, hypochlorite, or a combination thereof.

[0033] The present disclosure is further directed to a method of reducing inflammation in a mammal comprising administering to the mammal any of the compositions disclosed herein.

[0034] The present disclosure is further directed to a method of reducing viral symptoms in a mammal comprising administering to the mammal any of the compositions disclosed herein.

[0035] In an embodiment of the method disclosed herein, the composition is administered to the mammal once a day. In an embodiment of the method disclosed herein, the composition is administered to the mammal twice a day. In an embodiment of the method disclosed herein, the mammal is a human. [Brief explanation of the drawings]

[0036] [Figure 1] 1 is a graph showing a plot of viscosity (poise) versus shear rate (1 / sec) for two 5 mL samples of the gel formulation of Example 1, as tested in Example 3. Open circles: Sample 1; closed circles: Sample 2. DETAILED DESCRIPTION OF THE INVENTION

[0037] The present disclosure provides a composition comprising superoxide dismutase and soluble fiber. The composition disclosed herein can be used as a food supplement to increase the level of superoxide dismutase and soluble fiber in a subject. As described herein, the composition can also include additional ingredients such as antioxidants, vitamins, or other nutrients, along with excipients and other formulations.

[0038] It should be understood that the specific implementations shown and described herein are examples and are not intended to otherwise limit the scope of the present application in any way.

[0039] Published patents, patent applications, websites, company names, and scientific literature referred to herein are incorporated herein by reference in their entirety to the same extent as if each was specifically and individually indicated to be incorporated by reference. Any conflict between any reference cited herein and the specific teachings of this specification shall be resolved in favor of the latter. Similarly, any conflict between an art-understood definition of a word or phrase and a word or phrase specifically taught herein shall be resolved in favor of the latter.

[0040] As used herein, "a" or "an" may mean one or more. As used herein, the words "a" or "an," when used in conjunction with the word "comprising," may mean one or more. As used herein, "another" or "other" may mean at least a second or more.

[0041] Throughout this application, the term "about" is used to indicate that a value includes the inherent variation of error for the method / device being employed to determine the value or the variation that exists among the study subjects. Typically, the term "about" is intended to encompass a variation of approximately 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, or 20% or less, depending on the context.

[0042] Although use of the term "or" in the claims is used to mean "and / or" unless expressly specifying that only alternatives are referred to or that the alternatives are mutually exclusive, the present disclosure supports a definition that refers to only alternatives and "and / or."

[0043] As used herein, "comprising" (and any variation or form of comprising, e.g., "comprise" and "comprises"), "having" (and any variation or form of having, e.g., "have" and "has"), "including" (and any variation or form of including, e.g., "includes" and "include"), or "containing" (and any variation or form of containing, e.g., "contains" and "contain") is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.

[0044] The use of the term "for example" and its corresponding abbreviation "eg" (whether italicized or not) means that the particular terms recited are representative examples and embodiments of the present disclosure that are not limited to the particular examples mentioned or cited, unless expressly stated otherwise.

[0045] Unless otherwise defined, technical and scientific terms used herein have the meaning commonly understood by one of ordinary skill in the art to which this application pertains. Reference is made herein to various methods and materials known to those skilled in the art.

[0046] As used herein, the term "superoxide dismutase" (sometimes abbreviated as SOD) refers to the enzyme that converts the superoxide anion free radical (O - Superoxide dismutase refers to an enzyme that catalyzes the dismutation of O2, which is formed during the cellular metabolism of oxygen, into molecular oxygen and hydrogen peroxide (H2O2). Superoxide dismutase has the enzyme classification (EC) number 1.15.1.1. Superoxide dismutase prevents cells from converting O2, which is formed during the cellular metabolism of oxygen. -Superoxide dismutase is an important component in protecting cells from damage caused by reactive oxygen species (ROS), such as ATP. Thus, superoxide dismutase acts as an important antioxidant and is present in almost all types of cellular organisms. However, particularly in complex organisms such as mammals, the cellular levels of superoxide dismutase decrease as the organism ages, making the organism more susceptible to cellular damage caused by reactive oxygen species.

[0047] As used herein, the term "soluble fiber" refers to any type of water-soluble dietary fiber. When consumed, soluble fiber absorbs water and forms a gel in the intestines of an organism, which helps slow the metabolism of lipids and carbohydrates. Soluble fiber is also prebiotic, meaning it can be fermented by intestinal bacteria, helping to maintain a healthy intestinal microflora.

[0048] As used herein, the term "antioxidant" refers to a substance that significantly reduces the harmful effects of reactive species, such as reactive oxygen and nitrogen species, by totally or partially neutralizing the reactive species. Antioxidants can be classified as "primary antioxidants" and "secondary antioxidants." Primary antioxidants delay or inhibit the initiation step of oxidation, while secondary antioxidants slow oxidation by scavenging substrates or quenching free oxygen radicals.

[0049] Superoxide Dismutase and Soluble Fiber In embodiments disclosed herein, the composition comprises an amount of superoxide dismutase, measured in units of activity per mg of protein. For enzyme activity, one unit (U) (expressed in μmol / min) is defined as the amount of enzyme that catalyzes the conversion of 1 micromole of substrate per minute under specified conditions. Units of superoxide dismutase activity can be measured by any known method. For example, methods for determining superoxide dismutase activity, expressed in units, are described in McCord, JM, and Fridovich, I., J. Biol. Chem. 1969, 244:6049-6055; Weydert et al., Nature Protocols 2010, 5(1): 51-66; and the technical protocol at https: / / www.sigmaaldrich.com / technical-documents / protocols / biology / enzymatic-assay-of-superoxide-dismutase.html, the disclosures of each of which are incorporated herein by reference. In embodiments, a unit of superoxide dismutase activity is defined as the amount of superoxide dismutase that inhibits the rate of cytochrome c reduction by 50% in a 3.0 ml reaction volume at pH 7.8 and 25°C in a coupled system using xanthine and xanthine oxidase.

[0050] In embodiments, the compositions disclosed herein comprise a high concentration of superoxide dismutase, such as 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 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, or from about 5 units / mg to about 2000 units / mg of superoxide dismutase, and soluble fiber. In embodiments, the composition comprises about 1 unit / mg to about 1000 units / mg, about 1 unit / mg to about 750 units / mg, about 1 unit / mg to about 500 units / mg, or about 1 unit / mg to about 250 units / mg. In embodiments, the compositions disclosed herein comprise about 0.5 units / mg to about 100 units / mg of superoxide dismutase and soluble fiber. In embodiments, the composition comprises about 1 unit / mg to about 50 units / mg of superoxide dismutase. In embodiments, the composition comprises about 5 units / mg to about 25 units / mg of superoxide dismutase. In embodiments, the composition comprises about 10 units / mg to about 15 units / mg of superoxide dismutase. In 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 of superoxide dismutase, hi embodiments, the composition comprises about 14 Units / mg of superoxide dismutase.

[0051] The superoxide dismutase used in the compositions disclosed herein can be obtained from any enzyme source. In embodiments, the dismutase is extracted from melon, beef liver, heterotrophic bacteria, or marine phytoplankton. The superoxide dismutase can be any type of enzyme. In embodiments, the superoxide dismutase is copper / zinc superoxide dismutase, iron / manganese superoxide dismutase, or nickel superoxide dismutase.

[0052] In embodiments, the superoxide dismutase is extracted from a plant. In embodiments, the plant is a fruit, a grain, or a tuber. In embodiments, the plant is a fruit selected from melon, citrus, peach, pear, apple, or banana. In embodiments, the plant is a grain selected from wheat, barley, rye, millet, oat, spelt, bulgur, sorghum, and emmer wheat. In embodiments, the plant is a tuber selected from horseradish, potato, yam, sweet potato, cassava, or dahlia.

[0053] In embodiments, the superoxide dismutase is extracted from an animal, hi embodiments, the animal is a cow, a pig, a sheep, or a goat.

[0054] In embodiments, the superoxide dismutase is extracted from a microorganism. In embodiments, the microorganism is a phytoplankton or a bacterium. In embodiments, the microorganism is a heterotrophic bacterium, e.g., a bacterium that obtains the sugars needed to produce energy from their environment.

[0055] The ratio of superoxide dismutase to soluble fiber can be adjusted as needed by varying the amounts of either or both components of the composition. In embodiments, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:100 to about 1:1000 by mass. In embodiments, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:200 to about 1:800 by mass. In embodiments, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:300 to about 1:700 by mass. In embodiments, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:500 to about 1:700 by mass. In embodiments, the ratio of superoxide dismutase to soluble fiber in the composition is about 1:650 to 1:675 by mass.

[0056] Various types of soluble fiber can be used in the compositions disclosed herein, including mixtures of two, three, four, five, six, or more different types of soluble fiber. In embodiments, the soluble fiber is a water-soluble polysaccharide. In embodiments, the soluble fiber is isolated from corn, wheat, barley, rye, beans, apples, pears, peaches, citrus fruits, berries, peas, rice bran, or oats. In embodiments, the soluble fiber is selected from soluble corn fiber, inulin, dextrin, guar gum, oligopolysaccharides, galactopolysaccharides, fructo-oligosaccharides, lactulose, resistant starch, xylooligosaccharides, and isomerto-oligosaccharides. In embodiments, the soluble fiber is soluble corn fiber. In embodiments, the soluble fiber is resistant maltodextrin. In embodiments, the soluble fiber is Fibersol-2®, sold by Archer Daniels Midland and Matsutani Chemical Industry Co. In embodiments, the soluble fiber is an alternative type of Fibersol-2®, such as Fibersol-2AG, Fibersol-LQ, Fibersol-2L, Fibersol-DLQ, or non-GMO Fibersol.

[0057] powder composition In some embodiments of the compositions disclosed herein, the compositions are in the form of a powder. In embodiments where the compositions are in the form of a powder, the compositions can be consumed in dry powder form or added to beverages or foods. In embodiments, the powder is mixed into water, hydration drinks, protein shakes, juice, tea, coffee, milk, kefir, ice cream, yogurt, smoothies, broth, or soup before consumption.

[0058] In embodiments, the powder composition comprises a high concentration of superoxide dismutase, e.g., greater than 0.1 ppm, greater than 0.5 ppm, greater than 1 ppm, greater than 2 ppm, greater than 5 ppm, greater than 10 ppm, greater than 20 ppm, greater than 50 ppm, greater than 100 ppm, greater than 200 ppm, greater than 300 ppm, greater than 400 ppm, or greater than 500 ppm by weight. In embodiments, the powder composition comprises from about 0.1 ppm to about 10 ppm by weight of superoxide dismutase. In embodiments, the powder composition comprises from about 0.5 ppm to about 5 ppm by weight of superoxide dismutase. In embodiments, the powder composition comprises from about 0.7 ppm to about 2 ppm by weight of superoxide dismutase. In embodiments, the powder composition comprises from about 0.8 ppm to about 1.2 ppm by weight of superoxide dismutase. In 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 10.0 ppm by weight of superoxide dismutase.

[0059] In embodiments, the powder composition comprises about 1% to about 90% soluble fiber by weight. In embodiments, the powder composition comprises about 1% to about 50% soluble fiber by weight. In embodiments, the powder composition comprises about 5% to about 25% soluble fiber by weight. In embodiments, the powder composition comprises about 10% to about 20% soluble fiber by weight. In embodiments, the powder composition comprises about 12% to about 14% soluble fiber by weight. In 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% soluble fiber by weight.

[0060] Liquid or gel compositions In embodiments of the compositions disclosed herein, the compositions are in the form of a gel. In embodiments of the compositions disclosed herein, the compositions are in the form of a liquid. In embodiments where the composition is in the form of a gel or liquid, it can be consumed directly in that form. In other embodiments, the gel or liquid can be added to a beverage or food. In embodiments, the powder is mixed into water, hydration drinks, protein shakes, juice, tea, coffee, milk, kefir, ice cream, yogurt, smoothies, broth, or soup before consumption.

[0061] In embodiments, the gel or liquid composition comprises from about 0.005 mg / mL to about 5.0 mg / mL of superoxide dismutase. In embodiments, the gel or liquid composition comprises from about 0.01 mg / mL to about 2.5 mg / mL of superoxide dismutase. In embodiments, the gel or liquid composition comprises from about 0.05 mg / mL to about 1.0 mg / mL of superoxide dismutase. In embodiments, the gel or liquid composition comprises from about 0.1 mg / mL to about 0.5 mg / mL of superoxide dismutase. In 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 3.0 mg / mL of superoxide dismutase.

[0062] In embodiments, the gel or liquid composition comprises about 50 mg / mL to about 1000 mg / mL of soluble fiber. In embodiments, the gel or liquid composition comprises about 70 mg / mL to about 500 mg / mL of soluble fiber. In embodiments, the gel or liquid composition comprises about 90 mg / mL to about 250 mg / mL of soluble fiber. In embodiments, the gel or liquid composition comprises about 100 mg / mL to about 200 mg / mL of soluble fiber. In 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 500 mg / mL soluble fiber.

[0063] fruit juice In embodiments of the compositions disclosed herein, the composition comprising superoxide dismutase and soluble fiber also comprises fruit juice, which can provide additional antioxidants, soluble fiber, insoluble fiber, vitamins, and nutrients to the composition.

[0064] In embodiments, the fruit juice is pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, acai 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, lychee juice, pineapple juice, prune juice, or a combination thereof. In embodiments, the composition comprises 2, 3, 4, 5, or 6 types of juice selected from pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, acai 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, lychee juice, pineapple juice, and prune juice.

[0065] In embodiments, the fruit juice can be concentrated, e.g., the fruit juice can have some of the water in the original juice removed. In embodiments, the fruit juice is concentrated pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, acai 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, lychee juice, pineapple juice, prune juice, or a combination thereof. In embodiments, the composition contains two, three, four, five, or six types of juice concentrate selected from concentrated pomegranate juice, concentrated red grape juice, concentrated blueberry juice, concentrated dark sweet cherry juice, concentrated sour cherry juice, concentrated goji berry juice, concentrated acai berry juice, concentrated blackberry juice, concentrated raspberry juice, concentrated strawberry juice, concentrated gooseberry 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 lychee juice, concentrated pineapple juice, and concentrated prune juice. In embodiments, the concentrated juice has had about 60% to about 97% of the water removed from the juice. In embodiments, the concentrated juice has had about 85% to about 95% of the water removed from the juice. In embodiments, the concentrated juice has about 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% of the water removed from the juice. Water can be removed from the juice using any method known in the art for concentrating juice.

[0066] In embodiments, the composition comprises about 5 mg / mL to about 200 mg / mL of concentrated fruit juice. In embodiments, the composition comprises about 75 mg / mL to about 150 mg / mL of concentrated pomegranate juice. In embodiments, the composition comprises about 75 mg / mL to about 150 mg / mL of concentrated red grape juice. In embodiments, the composition comprises about 25 mg / mL to about 100 mg / mL of concentrated blueberry juice. In embodiments, the composition comprises about 20 mg / mL to about 80 mg / mL of concentrated dark sweet cherry juice. In embodiments, the composition comprises about 20 mg / mL to about 80 mg / mL of concentrated sour cherry juice. In embodiments, the composition comprises about 2 mg / mL to about 20 mg / mL of concentrated goji berry juice. In embodiments, the composition comprises about 2 mg / mL to about 20 mg / mL of concentrated acai berry juice.

[0067] Other additional ingredients In embodiments of the compositions disclosed herein, the composition comprising superoxide dismutase and soluble fiber also comprises aloe vera, which can provide additional antioxidants, soluble fiber, insoluble fiber, vitamins, and nutrients to the composition.

[0068] In some embodiments, the aloe vera is concentrated aloe vera. In embodiments, the aloe vera can be concentrated, for example, extracted from an aloe vera plant and some of the water removed. In embodiments, the concentrated aloe vera has about 60% to about 97% of the water removed from the aloe vera. In embodiments, the concentrated aloe vera has about 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, or 99% of the water removed from the aloe vera. In embodiments, the composition contains about 2 mg / mL to about 20 mg / mL of concentrated aloe vera.

[0069] In embodiments of the compositions disclosed herein, the composition comprising superoxide dismutase and soluble fiber also comprises green tea, which can provide additional antioxidants, vitamins, and nutrients to the composition.

[0070] In embodiments, the green tea is concentrated green tea. In embodiments, the concentrated green tea is a green tea extract made from green tea leaves or green tea powder. In embodiments, the green tea is added to the composition in powder form. In embodiments, the composition comprises about 2 mg / mL to about 20 mg / mL of concentrated green tea.

[0071] In some embodiments of the compositions disclosed herein, the composition comprising superoxide dismutase and soluble fiber also comprises resveratrol, which can provide additional antioxidant properties to the composition. In some embodiments, the composition comprises about 0.5 mg / mL to about 6 mg / mL of resveratrol.

[0072] Excipients / Formulations In embodiments, the compositions disclosed herein can be combined with one or more excipients. In embodiments, the excipient is a gelling agent, a thickener, a carrier, a buffer, or a bulking agent. In embodiments, the compositions disclosed herein can be formulated in beverages or foodstuffs. In embodiments, the compositions are formulated in juice, hydration drinks (e.g., sports drinks), protein shakes, tea, coffee, milk, kefir, ice cream, yogurt, smoothies, broths, or soups.

[0073] In embodiments, the composition comprises the thickening / gelling agent carboxymethylcellulose. In embodiments, the composition is a gel comprising superoxide dismutase, soluble fiber, and carboxymethylcellulose. In embodiments, the composition comprises about 0.5 to about 5.0 mg / mL of carboxymethylcellulose.

[0074] In embodiments, the composition includes the thickening / gelling agent xanthan gum. In embodiments, the composition is a gel comprising superoxide dismutase, soluble fiber, and xanthan gum. In embodiments, the composition includes about 0.5 to about 5.0 mg / mL of xanthan gum.

[0075] In an embodiment, the composition comprises: a) about 0.5 units / mg to about 100 units / mg of superoxide dismutase; b) soluble fiber; and c) at least two fruit juices selected from pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice. In an embodiment, the composition comprises at least three fruit juices. In an embodiment, the composition comprises at least four fruit juices. In an embodiment, the composition comprises at least five fruit juices. In an embodiment, the composition comprises at least six fruit juices. In an embodiment, the composition comprises pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice. In an embodiment of the composition, the fruit juice is a fruit juice concentrate. In an embodiment of the composition, the soluble fiber is soluble corn fiber. In an embodiment, the soluble corn fiber is resistant maltodextrin.

[0076] In an embodiment, the composition comprises: a) superoxide dismutase; b) soluble fiber; c) at least two fruit juices selected from pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice; d) aloe vera; e) green tea; and f) resveratrol. In an embodiment, the composition comprises at least three fruit juices. In an embodiment, the composition comprises at least four fruit juices. In an embodiment, the composition comprises at least five fruit juices. In an embodiment, the composition comprises at least six fruit juices. In an embodiment, the composition comprises pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice. In an embodiment, the fruit juice is a concentrated fruit juice. In an embodiment, the soluble corn fiber is resistant maltodextrin. In an embodiment, the composition also comprises carboxymethylcellulose. In an embodiment, the composition also comprises xanthan gum.

[0077] In one embodiment, the composition contains: a) about 30 to about 1000 units of superoxide dismutase; b) about 50 to about 200 mg / mL of soluble corn fiber; c) about 5 to about 200 mg / mL of at least two fruit juice concentrates selected from pomegranate juice, red grape juice, blueberry juice, dark sweet cherry juice, sour cherry juice, goji berry juice, and acai berry juice; d) about 2 to about 20 mg / mL of concentrated aloe vera; e) about 2 to about 20 mg / mL of concentrated green tea; and f) about 0.5 to about 6 mg / mL of resveratrol. In one embodiment, the soluble corn fiber is resistant maltodextrin. In another embodiment, the composition also contains about 0.5 to about 5.0 mg / mL of carboxymethylcellulose. In embodiments, the composition also includes about 0.5 to about 5.0 mg / mL of xanthan gum.

[0078] In some embodiments, the present invention provides nutritional liquid formulations containing soluble fiber and multiple antioxidants.

[0079] In some embodiments, the formulation includes soluble corn fiber. The corn fiber can comprise about 1 to about 5 weight percent of the total formulation. The corn fiber can be in the form of a dry powder.

[0080] In some embodiments, the soluble fiber is corn-based resistant maltodextrin (Fibersol-2) prebiotic fiber. Prebiotics are selectively fermented ingredients that enable specific changes in both the composition and / or activity of the gut microbiota that confer health benefits.

[0081] In some embodiments, the antioxidant of the formulation includes various polyphenols. The polyphenols may comprise about 1 to about 3 weight percent of the total composition. In some embodiments, the antioxidant of the formulation includes superoxide dismutase (SOD).

[0082] In some embodiments, the present disclosure provides a blend of soluble corn fiber, concord red grape (Vitis Labrusca) juice concentrate, pomegranate (Punica Granatum) juice concentrate, blueberry (Vaccinium Corymbosum) juice concentrate, dark sweet cherry (Prunus Avium) juice concentrate, sour cherry (Prunus Cerasus) juice concentrate, goji berry (Lycium Barbarum) puree, acai (Euterpe Oleraceae) berry juice concentrate, aloe vera juice concentrate (Aloe barbadensis Mill), green tea extract (Camellia sinensis), and / or citric acid. The present invention provides a nutritional supplement formulation containing Cucumis melo L. (Cucumis melo L.), resveratrol, melon juice concentrate (Cucumis melo L.), and Extramel-SOD.

[0083] The soluble fiber and antioxidant formulations of the present disclosure have a synergistic effect, as soluble prebiotic fiber acts as fertilizer for bacteria in the colon, while polyphenols are absorbed in a substantial part of the colon and are subject to extensive catabolism by the colonic microflora. The presence of prebiotic fiber enhances the activity of the colonic microflora, thereby leading to more effective absorption of polyphenols in the colon. Most of the polyphenols from antioxidant supplements ultimately reach the large intestine, where they undergo microbial metabolism into their active metabolites, which can exert their antioxidant effects. Soluble fiber modulates the intestinal microflora, maximizing the metabolism of polyphenols and exerting many antioxidant, anti-inflammatory, and anti-infective effects.

[0084] In some embodiments, the composition comprises the ingredients shown in Table 1 in the amounts indicated.

[0085] [Table 1]

[0086] Reactive oxygen species and oxygen radical absorbance capacity In embodiments, the compositions disclosed herein are useful for reducing intracellular reactive oxygen species (ROS) levels. In some embodiments, the reactive oxygen species whose levels are reduced include one or more of peroxide, superoxide, hydroxyl radical, singlet oxygen, and alpha-oxygen species. In embodiments, the reactive oxygen species whose levels are reduced include one or more of peroxyl radical, hydroxyl radical, peroxynitrite, superoxide anion, singlet oxygen, or hypochlorite species.

[0087] The present disclosure provides the discovery that compositions comprising superoxide dismutase in combination with soluble fiber result in significantly increased oxygen radical absorbance capacity (ORAC). The addition of soluble fiber to compositions comprising superoxide dismutase exerts a synergistic effect to increase oxygen radical absorbance capacity, i.e., the ORAC value of the combination is much greater than the additive value of the uncombined superoxide dismutase and soluble fiber.

[0088] In embodiments, the ability of the compositions disclosed herein to reduce intracellular reactive oxygen species levels 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 for Measuring Oxidative Stress in the Laboratory," A. Dasgupta et al., Antioxidants in Food, Vitamins and Supplements (2014, Elsevier), pp. 19-40, which is hereby incorporated by reference.

[0089] Generally, 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 reactive oxygen species. A reactive oxygen species inducer is introduced into the assay system. The inducer is thought to induce the release of specific reactive oxygen species, which degrades the probe and causes a change in the wavelength or intensity of the emission from the probe. The antioxidant material present in the assay absorbs the reactive oxygen species and prevents the probe from degrading. Therefore, the degree of preservation of the probe indicates the antioxidant capacity of the material.

[0090] In embodiments, the fluorescent probe used in the ORAC assay is beta-phycoerythrin or fluorescein. In embodiments, the ORAC capacity of an antioxidant is measured relative to a standard. In embodiments, the standard is the known antioxidant Trolox® (6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid), which is a vitamin E analog. In embodiments where Trolox® is used as the standard, the results can be expressed as "total antioxidant capacity" (TAC) for the tested molecule, expressed as micromoles (μmol) Trolox® equivalents (TE) per gram of the tested antioxidant molecule.

[0091] In one embodiment, the ORAC assay measures one or more of the reactive oxygen species peroxyl radical, hydroxyl radical, peroxynitrite, superoxide dismutase, singlet oxygen, and hypochlorite. In one embodiment, the ORAC assay is the ORAC 6.0 assay performed by Brunswick Laboratories, Southborough, MA, USA. The ORAC 6.0 assay tests antioxidant capacity against peroxyl radical, hydroxyl radical, peroxynitrite, superoxide dismutase, singlet oxygen, and hypochlorite.

[0092] In any embodiment of the compositions disclosed herein, the composition has a total ORAC greater than 1000 μmol / g composition. In any embodiment of the compositions disclosed herein, the composition has an ORAC greater than 1500 μmol / g composition. In any embodiment of the compositions disclosed herein, the composition has a total ORAC greater than 700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, or 2000 μmol / g composition. As used herein, "total ORAC" refers to the sum of the ORAC values ​​for each reactive oxygen species. For example, in embodiments using the ORAC 6.0 assay, the total ORAC is the sum of the ORAC values ​​for peroxyl radical, hydroxyl radical, peroxynitrite, superoxide dismutase, singlet oxygen, and hypochlorite. In embodiments, the total ORAC value is divided by the mass of the composition in grams to obtain a μmol / g value.

[0093] In any embodiment of the compositions disclosed herein, the ORAC value for the composition is at least 1.5 times higher than the sum of the individual ORAC values ​​for each component of the composition. In any embodiment of the compositions disclosed herein, the ORAC value for the composition is at least 1.6 times higher than the sum of the individual ORAC values ​​for each component of the composition. In any embodiment of the compositions disclosed herein, the ORAC value for 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 individual ORAC values ​​for each component of the composition.

[0094] viscosity In embodiments, the compositions disclosed herein have viscosity characteristics that stabilize the composition. In embodiments, the composition is a shelf-stable, high-viscosity gel that retains its flavor over time and allows minimal oxygen permeation into the composition. In embodiments, the composition is thixotropic, having a high viscosity when stored and a lower viscosity when agitated, for example by shaking or administration. In embodiments, the composition is a thixotropic, high-viscosity gel that has good stability when stored and a lower viscosity when administered, facilitating easy administration and ingestion and favorable distribution and absorption in the gastrointestinal tract. In embodiments, the composition has a viscosity of about 23 poise or greater at a shear rate of 1 / sec. In embodiments, the composition has a viscosity of about 5 poise or less at a shear rate of 10 / sec. In embodiments, the composition has a viscosity of about 1 poise or less at a shear rate of 100 / sec. In embodiments, the composition has a viscosity of about 23 poise or greater at a shear rate of 1 / sec, a viscosity of about 5 poise or less at a shear rate of 10 / sec, and a viscosity of about 1 poise or less at a shear rate of 100 / sec.

[0095] method The present disclosure is also directed to a method for reducing the number of free oxygen radicals in a mammal, comprising administering any of the compositions disclosed herein to the mammal. In embodiments, the free oxygen radicals whose number is reduced are selected from peroxy radicals, hydroxyl radicals, peroxynitrite, superoxide anions, singlet oxygen, hypochlorite, and combinations thereof. In embodiments, the method may reduce two, three, four, five, or six types of free oxygen radicals. In embodiments, the free oxygen radicals whose number is reduced are selected from peroxy radicals, hydroxyl radicals, peroxynitrite, superoxide anions, singlet oxygen, and hypochlorite in the mammal.

[0096] In some embodiments, the synergistic effect observed with the superoxide dismutase / soluble fiber combination results in a high oxygen radical absorbance capacity (ORAC), which beneficially reduces inflammation. The present disclosure is further directed to a method of reducing inflammation in a mammal, comprising administering to the mammal any of the compositions disclosed herein. The present disclosure is further directed to a method of treating any disease or disorder in a mammal associated with elevated levels of reactive oxygen species, comprising administering to the mammal any of the compositions disclosed herein. In embodiments, the disease or disorder is a bacterial infection; a viral infection; radiation damage; a demyelinating disease such as multiple sclerosis or neuropathy; a joint disorder such as arthritis, rheumatoid arthritis, or psoriatic arthritis; a skin disorder such as psoriasis, rosacea, acne vulgaris, dermatitis, or urticaria; a neurodegenerative disorder such as multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Alzheimer's disease, or Huntington's disease; a neuromuscular disease such as muscular dystrophy, myasthenia gravis; or tremors. intestinal disorders such as gastrointestinal inflammation, inflammatory bowel disease, Crohn's disease, colitis, diarrhea, leaky gut syndrome, diverticulitis, or celiac disease; asthma; inflammatory diseases such as autoimmune diseases, diabetes, gout, chronic prostatitis, glomerulonephritis, hidradenitis suppurativa, interstitial cystitis, lichen planus, mast cell activation syndrome, mastocytosis, otitis, pelvic inflammatory disease; reperfusion injury; chronic fatigue syndrome; rheumatic fever; rhinitis; sarcoidosis; transplant rejection; and vasculitis.

[0097] In some embodiments, the synergistic effects observed with the superoxide dismutase / soluble fiber combination result in a high oxygen radical absorbance capacity (ORAC), which is beneficial for the prevention and treatment of viral infections. In embodiments, the compositions disclosed herein can be used in methods for preventing viral infections, including influenza A, influenza B, influenza C, influenza D, SARS (Severe Acute Respiratory Syndrome), SARS-CoV-2 (which causes COVID-19), coronaviruses, including MERS (Middle East Respiratory Syndrome), HIV, Ebola, rhinovirus, and respiratory syncytial virus infections. In embodiments, the compositions disclosed herein can be used in methods for treating viral infections, including influenza A, influenza B, influenza C, and influenza D, including SARS (Severe Acute Respiratory Syndrome), SARS-CoV-2 (which causes COVID-19), MERS (Middle East Respiratory Syndrome), HIV, Ebola, rhinovirus, and respiratory syncytial virus infections.

[0098] In some embodiments, the synergistic effect observed with the superoxide dismutase / soluble fiber combination provides a high oxygen radical absorbance capacity (ORAC), which is beneficial for supplementing the diet of subjects undergoing cancer treatment. In embodiments, the compositions disclosed herein can be used in methods for supplementing the diet of mammals undergoing cancer treatment, exposed to radiation, or suffering from malnutrition.

[0099] In some embodiments of the methods disclosed herein, the composition is administered to the mammal once daily. In some embodiments of the methods disclosed herein, the composition is administered to the mammal twice daily. In some embodiments of the methods disclosed herein, the composition is administered to the mammal 3, 4, 5, 6, 7, 8, 9, 10, or more times daily.

[0100] In any of the 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), domestic animal (e.g., dog, cat, rabbit, hamster, guinea pig, mouse, rat), or agricultural animal (e.g., cow, sheep, horse, goat, pig). [Example]

[0101] Example 1 Example Formulations Example formulations were prepared having the ingredients and concentrations shown in Table 2:

[0102] [Table 2]

[0103] Ingredients 1-12 were combined into a homogenous blend using a stainless steel mixing tank. The ingredients were weighed according to the batch size before mixing. The juice concentrate was first mixed in a separate tank, then the solid ingredients were premixed with water in a separate mixer, and the two mixtures were combined in the main mixing tank. Sufficient water was added to the required volume and the product was properly mixed. The final product was sterilized and then packaged in pouches. The formulation is a gel that is dark red in color.

[0104] Example 2 ORAC Testing of Example Formulations Testing was performed to determine the ORAC values ​​of various components of the formulation of Example 1 compared to the formulation as a whole. Individual component samples were prepared using the weight amounts of the sample in the total formulation: Sample A: 4 g soluble corn fiber (Fibersol-2®); Sample B: 13.8749 g fruit juice concentrate blend; and Sample C: 0.006 g superoxide dismutase isolated from melon. Sample D was the final product formulation, weighing 31.1 g. Samples were sent to Brunswick Laboratories (Southborough, MA, USA) and tested using the ORAC 6.0 assay as described above and available at https: / / brunswicklabs.com / capabilities / bioanalytical-services / orac-family / orac6 / . The results of the assay are shown in Table 3, where "Test Result" is expressed as μmol Trilox equivalents per gram of sample tested. The "Transformation" column shows the transformation of the ORAC values ​​normalized for sample amount.

[0105] [Table 3]

[0106] As seen in Table 3, final product Sample D exhibits an unexpected and significantly higher ORAC value (48,021.79) compared to the sum of the individual component Samples A-C (29,094.26). Thus, ORAC testing suggests a synergistic effect between the components of the formulation of Example 1 when these components are combined. Without wishing to be bound by theory, one potential contribution to this synergy is that the other components exert a possible stabilizing effect on the superoxide dismutase enzyme, allowing superoxide dismutase to more effectively neutralize reactive oxygen species.

[0107] Example 3 Viscosity Test of Example Formulations The viscosity of the formulation of Example 1 was tested under various amounts of shear stress. A dynamic viscometer was used to test 5 ml of the formulation gel at a temperature of 25° C. The viscosity (in poise) was tested over time under high shear stress and shear rate for two separate samples of the formulation gel, as shown in Tables 4 and 5. The normal stress at each time point is also shown.

[0108] [Table 4]

[0109] [Table 5]

[0110] The results presented in Tables 4 and 5 are plotted in Figure 1. As can be seen in Tables 4 and 5 and Figure 1, the gel formulation is unexpectedly thixotropic, as it becomes less viscous after the application of shear stress. This thixotropic property can provide several advantages to gel formulations. At rest, the gel formulation is a highly viscous gel, helping the product maintain its physical composition, preserve its flavor, and minimize oxygen permeation. During administration, agitation of the gel formulation reduces the viscosity, and the resulting increased fluidity facilitates oral administration while also favoring the formulation's distribution within the gastrointestinal tract, thereby facilitating absorption.

[0111] Example 4 Improved recovery in COVID-19 patients It was theorized that the superoxide dismutase and soluble fiber compositions described herein may help strengthen the immune system, making subjects ingesting the compositions less susceptible to and better able to recover from viral or bacterial infections more quickly. Accordingly, the gel formulation of Example 1 was given to several patients who tested positive for COVID-19, the disease caused by the SARS-CoV-2 virus. Current indications from medical professionals and researchers are that it may take up to two weeks to recover from COVID-19. All patients given the gel formulation, regardless of age or gender, recovered more quickly than expected.

[0112] Patient 1, a man between 41 and 50 years old, tested positive for COVID-19 and suffered from fever, cough, and loss of taste. Five days after his positive test, he began taking the gel twice daily. Within three to four days of starting the gel, Patient 1 reported feeling much better, less tired, and more energetic.

[0113] Patient 2, a woman aged 18-20 years, tested positive for COVID-19 and presented with fever, cough, and headache. She began taking the gel formulation once daily on the day of her positive test. Within 3 to 4 days of starting the gel formulation, Patient 2 reported feeling better, more energetic, and less fatigued.

[0114] Patient 3, a man between the ages of 31 and 40, tested positive for COVID-19 and presented with a fever, cough, and headache, along with feeling very weak. He began taking the gel formulation once or twice daily four days after his positive test. Within two days of starting the gel formulation, Patient 3 reported feeling better, no longer feeling weak, and having more energy.

[0115] Patient 4, a woman aged 61-70 years, tested positive for COVID-19 and was hospitalized with symptoms of fever, cough, headache, and loss of taste. She began taking the gel formulation once daily 5 days after her positive test. Within 3 to 4 days, she felt better, had more energy, and felt less fatigued.

[0116] Patient 5, a man between 20 and 30 years old, tested positive for COVID-19 and suffered from fever, cough, and headache. He began taking the gel formulation once daily three days after his positive test. Within two to four days, he felt better, more energetic, and less fatigued.

[0117] Example 5 Improves diabetes-related fatigue The patient was a middle-aged woman who had recently been diagnosed with diabetes. Despite following a careful diet, she suffered from excessive fatigue and had an elevated A1C level of approximately 10.2%. She began taking the gel formulation of Example 1, and by the end of the first day of intake, she began to feel energized. After three days of taking the gel formulation, she reported feeling energized "far beyond anything she could have ever imagined."

[0118] Example 6 Improvement of symptoms of myasthenia gravis The patient was a woman between 35 and 45 years old with a rare form of muscular dystrophy called myasthenia gravis. The disease affected nearly the entire muscular system, including breathing, walking, speaking, swallowing, and eye movements. In July 2019, she was hospitalized due to her condition and required the use of a wheelchair. She was unable to walk more than a few feet and had difficulty breathing. Her symptoms led to her being placed on a regimen of prednisone at a daily dose of 40 mg. She began taking the gel formulation of Example 1 once daily along with the powdered superoxide dismutase / soluble fiber formulation described herein. After three days, she began to notice an improvement in her symptoms and felt more energetic. After several months of taking this combination of gel and powder formulations, she now only takes 5 mg of prednisone daily and is able to be active and walk long distances. She no longer has problems swallowing or speaking, and no longer has problems with eye movements.

[0119] Example 7 Improvement of symptoms of multiple sclerosis The patient was a woman between 35 and 45 years old with multiple sclerosis. Her symptoms initially began in her legs but then progressed to her right arm. She experienced frequent pain, suffered from excessive fatigue, and had trouble sleeping. She began taking the gel formulation of Example 1, and shortly thereafter, was able to move her right arm with only minor pain. After taking the product for several months, she experienced significantly less pain and fatigue and was sleeping better. She was able to reduce the amount of medication she was taking, and went from walking approximately 3,500 steps per day to walking 11,000 steps per day.

[0120] Example 8 Improves gout symptoms The patient was a man between 40 and 50 years old who suffered from gout. He initially began taking the gel formulation of Example 1 as a post-workout recovery supplement and noticed an improvement in his symptoms after one month. When his gout suddenly flared up, he took the gel formulation of Example 1 twice daily, and after two days, his symptoms subsided.

[0121] Example 9 Improved recovery from viral symptoms The patient was a woman suffering from viral symptoms including shortness of breath and loss of taste. She tested negative for COVID-19. She took the gel formulation of Example 1 twice daily. After three days, she felt significantly better, and after five days, her viral symptoms were gone.

[0122] It will be readily apparent to those skilled in the relevant art that other suitable modifications and adaptations to the methods and applications described herein can be made without departing from the scope of any of the embodiments. The above examples are included herein for illustrative purposes only and are not meant to be limiting.

[0123] Although certain specific embodiments have been illustrated and described herein, it should be understood that the claims are not limited to the specific forms or arrangements of parts described and illustrated. Although the specification has disclosed exemplary embodiments and specific terms have been 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 should be understood, therefore, that the embodiments may be practiced otherwise than as specifically described.

[0124] While various embodiments have been described above, it should be understood that they have been presented merely as illustrations and examples of the present technology, and are not intended to be limiting in any way. It will be apparent to those skilled in the art that various changes in form and detail can be made therein without departing from the spirit and scope of the present technology. Thus, the breadth and scope of the present technology should not be limited to any of the above-described embodiments, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein and each reference cited herein can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated herein by reference in their entirety.

Claims

1. a) superoxide dismutase with an activity of 0.5 units / mg to 500 units / mg; b) a soluble prebiotic fiber having a ratio of superoxide dismutase to soluble fiber of 1:100 to 1:1000 by mass; A powder composition comprising:

2. 2. The powder composition of claim 1, wherein the soluble prebiotic fiber is selected from soluble corn fiber, inulin, guar gum, polysaccharide fiber, galactopolysaccharides, fructo-oligosaccharides, lactulose, resistant starch, xylooligosaccharides, and isomerto-oligosaccharides.

3. 10. The powder composition of claim 1, wherein the soluble prebiotic fiber is soluble corn fiber.

4. 4. The powder composition of claim 3, wherein the soluble corn fiber is resistant maltodextrin.

5. 10. The powder composition of claim 1, wherein the superoxide dismutase is extracted from melon, beef liver, heterotrophic bacteria, or marine phytoplankton.

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

7. 10. The powder composition of claim 1, wherein the superoxide dismutase is extracted from a plant.

8. 8. The powder composition of claim 7, wherein the plant is a fruit selected from melon, citrus, peach, pear, apple, or banana.

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

10. 10. The powder composition of claim 9, wherein the animal is a cow, a pig, a sheep, or a goat.

11. 2. The powder composition of claim 1, wherein the ratio of superoxide dismutase to soluble fiber is from 1:300 to 1:700 by mass.

12. 2. The powder composition of claim 1, wherein the ratio of superoxide dismutase to soluble fiber is from 1:500 to 1:700 by mass.

13. a) superoxide dismutase at a concentration of 0.005 mg / mL to 5.0 mg / mL; b) a soluble prebiotic fiber having a ratio of superoxide dismutase to soluble fiber of 1:100 to 1:1000 by mass; A liquid composition comprising:

14. 14. The liquid composition of claim 13, wherein the soluble prebiotic fiber is selected from soluble corn fiber, inulin, guar gum, polysaccharide fiber, galactopolysaccharides, fructo-oligosaccharides, lactulose, resistant starch, xylooligosaccharides, and isomerto-oligosaccharides.

15. 14. The liquid composition of claim 13, wherein the soluble prebiotic fiber is soluble corn fiber.

16. 16. The liquid composition of claim 15, wherein the soluble corn fiber is resistant maltodextrin.

17. 14. The liquid composition of claim 13, wherein the superoxide dismutase is extracted from melon, beef liver, heterotrophic bacteria, or marine phytoplankton.

18. 14. The liquid composition of claim 13, wherein the superoxide dismutase is copper / zinc superoxide dismutase, iron / manganese superoxide dismutase, or nickel superoxide dismutase.

19. 14. The liquid composition of claim 13, wherein the ratio of superoxide dismutase to soluble fiber is from 1:300 to 1:700 by mass.

20. 14. The liquid composition of claim 13, wherein the ratio of superoxide dismutase to soluble fiber is 1:500 to 1:700 by mass.

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