PERFORMANCE ENHANCEMENT DELIVERY SYSTEM

Abstract

The present disclosure provides an improvement of existing L-arginine containing supplements by providing both hydrogen crystals (H.sub.2) and co-enzyme Q10 (Co-Q10) to produce a nutrient formulation, including compositions containing said formulation and methods of administering such formulation.

Claims

1. A composition comprising co-enzyme Q10, hydrogen crystals, carbohydrates, vitamin C, vitamin D.sub.3, vitamin K, vitamin B.sub.6, folic acid, vitamin B.sub.12, Mg, L-arginine, L-citrulline, red wine extract, a ginseng mix, and a mineral mix.

2. The composition of claim 1, wherein the ginseng mix comprises Panax ginseng extract, Panax notoginseng extract, Rosa roxburghii extract, saponin, polyphenols, vitamin C, ginsenodide R1, and astragaloside.

3. The composition of claim 1, wherein the mineral mix comprises Al, Sb, Ba, Be, Bi, B, Br, Cd, C, Ce, Cl, Cr, Co, Cu, Dy, Er, Eu, F, Gd, Ge, Au, Hf, Ho, In, I, Ir, Fe, La, Li, Lu, Mg, Mn, Mo, Nd, Ni, Nb, Os, Pd, P, Pt, K, Pr, Re, Rh, Rb, Ru, Sm, Sc, Se, Si, Ag, Na, Sr, S, Ta, Te, Tb, Tl, Th, Tm, Sn, Ti, W, V, Yb, Y, An, Zr, and fluvic acid.

4. The composition of claim 1, wherein one serving of the composition comprises between about 50 mg to about 54 mg co-enzyme Q10, between about 80 mg to about 90 mg of hydrogen crystals.

5. The composition of claim 4, further comprising between about 4 g to about 5 g of carbohydrates, between about 60 mg to about 76 mg of vitamin C, between about 2500IU to 3155IU of vitamin D.sub.3, between about 20 μg to about 25 μg vitamin K, between about 2 mg to about 3 mg of vitamin B.sub.6, between about 400 mg to about 505 mg of folic acid, between about 6 μg and 8 μg of vitamin B.sub.12, between about 20 mg to about 25 mg of Mg, between about 5110 mg and 6450 mg of L-arginine, between about 1010 mg to about 1275 mg of L-citrulline, between about 100 mg to about 126 mg of red wine extract, between about 50 mg to about 63 mg of ginseng mix; and between about 100 mg to about 126 mg of mineral mix.

6. The composition of claim 5, wherein the composition further comprises one or more additional components selected from the group consisting of a carrier, an excipient, a binder, a colorant, a flavoring agent, a preservative, a buffer, a dilutant and combinations thereof.

7. The composition of claim 1, wherein the composition is a human dietary supplement.

8. The composition of claim 1, wherein the composition is in a dosage form selected from the group consisting of a capsule, a cachet, a pill, a tablet, a powder, a granule, a pellet, a bead, a particle, a troche, and a lozenge.

9. The composition of claim 1, wherein the one or more additional components is a carrier.

10. The composition of claim 1, wherein the one or more additional components is an excipient.

11. The composition of claim 1, wherein the one or more additional components is a binder.

12. The composition of claim 1, wherein the one or more additional components is a colorant.

13. The composition of claim 1, wherein the one or more additional components is a flavoring agent.

14. The composition of claim 1, wherein the one or more additional components is a preservative.

15. The composition of claim 1, wherein the one or more additional components is a buffer.

16. The composition of claim 1, wherein the one or more additional components is a dilutant.

17. A composition comprising: co-enzyme Q, hydrogen crystals, carbohydrates, vitamin C, vitamin D3, vitamin K, vitamin B.sub.6, folic acid, vitamin B.sub.12, Mg, L-arginine, L-citrulline, red wine extract, a ginseng mix, a mineral mix and one or more additional components selected from the group consisting of a carrier, an excipient, a binder, a colorant, a flavoring agent, a preservative, a buffer, and a dilutant, wherein the compositions is in a dosage form selected from the group consisting of a capsule, a cachet, a pill, a tablet, a powder, a granule, a pellet, a bead, a particle, a troche, and a lozenge.

18. The composition of claim 12, wherein the dosage form is a capsule.

19. The composition of claim 12, wherein the dosage form is a cachet.

20. The composition of claim 12, wherein the dosage form is a powder.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] FIG. 1 is a graph showing results of a study using the composition

DETAILED DESCRIPTION OF THE INVENTION

[0037] Before the present composition, methods and methodologies are described, it is to be understood that this invention is not limited to particular compositions, methods, and experimental conditions described, as such compositions, methods, and conditions may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[0038] As used in this specification and appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Thus, for example, references to “amino acid” includes one or more amino acids, and/or compositions of the type described herein which will become apparent to those persons skilled in the art upon reading this disclosure and so forth.

[0039] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Any methods and material similar or equivalent to those described herein can be used in the practice of testing of the invention, as it will be understood that modifications and variations are encompassed within the spirit and scope of the instant disclosure.

[0040] As used herein, “about,” “approximately,” “substantially,” and “significantly” will be understood by a person of ordinary skill in the art and will vary in some extent depending on the context in which they are used. If there are uses of the term which are not clear to persons of ordinary skill in the art given the context in which it is used, “about” and “approximately” will mean plus or minus <10% of the particular term and “substantially” and “significantly” will mean plus or minus >10% of the particular term. In embodiments, compositions may “contain,” “comprise,” or “consist essentially of” a particular component or group of components, where the skilled artisan would understand the latter to mean the scope of the claim is limited to the specified material or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention.

[0041] As shown below, Co-Q10 has the following molecular structure:

##STR00001##

[0042] As described above, L-arginine stimulates growth hormone release. While not being bound by theory, by keeping blood L-arginine levels high for an extended period of time, the combined composition as envisaged, allows for penetration across the blood brain barrier (BBB) and stimulates the pituitary to produce growth hormone, which thereby stimulates muscle build-up and aids in maintaining circulation and modulating homeostasis. The hydrogen component enhances the L-arginine penetration.

[0043] Arginine is characterized as a nonessential amino acid. Specifically, arginine can be independently manufactured by the human body, and does not need to be obtained directly through dietary intake. Arginine plays a significant role in healing, cell division, immune function, the elimination of ammonia from the body and the release of hormones. Arginine is presently used in the dietary supplement industry to supplement Arginine production in the body. Arginine is also presently used in the dietary supplement industry to boost human growth hormone (HGH) production, increase vasodilation, enhance blood circulation, increase oxygen flow to the muscles, and boost nitric oxide (NO) production. Various supplemental arginine forms are available in the consumer marketplace.

[0044] The vasodilating effect of ingested arginine takes considerable time to manifest since arginine requires extensive metabolism to yield NO. Additionally, considerable amounts of arginine are required to produce a significant vasodilating effect, with common doses ranging from eight to twenty-four grams per day.

[0045] Citrulline is an alpha-amino acid naturally occurring in the human body, and does not need to be obtained directly through dietary intake. In vivo, citrulline is made from the amino acid ornithine, along with carbamoyl phosphate in one of the central reactions in the urea cycle. Citrulline is also produced during the metabolism of arginine in the body. Citrulline is presently used in the dietary supplement industry to supplement citrulline production in the body. By itself, citrulline has no vasodilating properties. Citrulline is also water insoluble, which reduces its bioavailability and limits the forms in which citrulline may be effectively used.

[0046] By taking one scoop every 12 hours consisting of 15 to 20 grams of L-arginine will also cross the BBB and induce secretion of growth hormone, resulting in an increase in testosterone. This may be verified by measuring testosterone levels before and after subject ingests the formulation.

[0047] In embodiments, the composition contains a combination of co-enzyme Q10, hydrogen crystals, carbohydrates, vitamin C, vitamin D.sub.3, vitamin K, vitamin B.sub.6, folic acid, vitamin B.sub.12, Mg, L-arginine, L-citrulline, red wine extract, ginseng mix (i.e., Panax ginseng extract, Panax notoginseng extract, Rosa roxburghii extract, saponin, polyphenols, vitamin C, ginsenodide R1, and astragaloside; e.g., similar to ASTRAGIN®, available from NuLivScience, Brea, Calif.), and a mineral mix comprising the elements Al, Sb, Ba, Be, Bi, B, Br, Cd, C, Ce, Cl, Cr, Co, Cu, Dy, Er, Eu, F, Gd, Ge, Au, Hf, Ho, In, I, Ir, Fe, La, Li, Lu, Mg, Mn, Mo, Nd, Ni, Nb, Os, Pd, P, Pt, K, Pr, Re, Rh, Rb, Ru, Sm, Sc, Se, Si, Ag, Na, Sr, S, Ta, Te, Tb, Tl, Th, Tm, Sn, Ti, W, V, Yb, Y, An, Zr, and fluvic acid. In a related aspect, one serving of the composition (about 13 g to about 16 g) comprises between about 50 mg to about 54 mg co-enzyme Q10, between about 80 mg to about 90 mg of hydrogen crystals (equivalent to one hydrogen tablet, e.g., DRINKHRW® Rejuvenation, Oxnard, Calif.); between about 4 g to about 5 g of carbohydrates, between about 60 mg to about 76 mg of vitamin C, between about 2500IU to 3155IU of vitamin D.sub.3, between about 20 μg to about 25 μg vitamin K, between about 2 mg to about 3 mg of vitamin B.sub.6, between about 400 mg to about 505 mg of folic acid, between about 6 μg and 8 μg of vitamin B.sub.12, between about 20 mg to about 25 mg of Mg, between about 5110 mg and 6450 mg of L-arginine, between about 1010 mg to about 1275 mg of L-citrulline, between about 100 mg to about 126 mg of red wine extract, between about 50 mg to about 63 mg of ginseng mix; and between about 100 mg to about 126 mg of mineral mix.

[0048] Red wine (RW) extract is obtained after the fermentation process of grapes has been completed, which RW extract contains nutrients from the flesh, skin and seeds (may or may not have seeds, depending on the grapes) of grapes that have been fermented.

[0049] The compositions and formulations according to the present invention may further comprise one or more acceptable carriers or excipients. Acceptable carriers and excipients may be combined with (e.g., mixed with or coated with) the composition as disclosed herein. Carriers/excipients include fillers or extenders, binders, wetting agents, emulsifiers, and anti-caking agents.

[0050] Additionally, or alternatively, the carrier may be any of the one or more additives disclosed herein, wherein the contemplated composition is in powder form for any of the disclosed additives. As such, the additive may be used as the “platform” for the composition. In addition to the additives disclosed herein, additional carriers also include a polysaccharide complex. Examples of a polysaccharide complex include highly branched galactose. Galactose may be highly branched with rhamnose, arabinose, and/or glucuronic acid.

[0051] A wide number of acceptable carriers are well known in the art. The carrier need only be suitable for administration to a human and be able to act as a carrier without substantially affecting the desired activity of the composition. Also, the carrier(s) may be selected based on the desired administration route and dosage of the composition or formulation. For example, the compositions according to the present invention are suitable for are suitable for use on a variety of dosage forms such as liquid form and solid form (e.g., a chewable bar or wafer). In desirable embodiments as discussed below, the composition or formulation comprises a solid dosage form such as a tablet, caplet or capsule, lozenges, and chewing gum. Examples of suitable carriers for use in tablet, caplet and capsule compositions or formulations include, but are not limited to, inert organic and inert inorganic carrier materials such as gelatin, starch, magnesium stearate, talc, gums, silicon dioxide, stearic acid, cellulose and the like. Desirably, the carrier is substantially inert. In embodiments, the composition or formulation is tablet, caplet, capsule or lozenge which uses pharmaceutically acceptable controlled release, time release or extended release technology; suitable technologies are known in the art.

[0052] Advantageously, one or more of the exemplary compositions described herein may be used as a composition, either alone or part of a more complex composition containing any number of additional ingredients. It will be readily apparent to those skilled in the art which specific ingredients may be beneficially included in such compositions. Furthermore, any one or more of the exemplary compositions disclosed herein may be administered in any dosage form common in the art. For example, the compositions disclosed herein may be administered in the form of a powder to be mixed in a liquid, or a solid dosage form such as a tablet, caplet, capsule, a ready-to-mix (e.g., ready-to-drink (RTD)) formulation, lozenges, nutritional bars, food bars or candy bars. More specifically, the contemplated composition may be an effective dosage of the composition as disclosed herein is formulated as a powder to be mixed in a liquid or in a solid dosage form to be formed as one or more tablets, one or more caplets, one or more capsules, one or more lozenges, one or more nutritional bars, one or more food bars, or one or more candy bars.

[0053] In embodiments, the contemplated compositions disclosed herein may further include one or more pharmaceutically acceptable excipients or carriers. In a related aspect, the composition may be in the form of a powdered dietary supplement (e.g., ready-to-mix or RTD powder), capsule, tablet, caplet, or lozenge. In a further related aspect, the compositions may be formulated (e.g., agglomerated) to be shelf stable for six, twelve, eighteen, twenty, twenty-four, thirty, thirty-six, forty, forty-two, forty-eight months or longer.

[0054] In embodiments, the contemplated composition is a nutraceutical. In a related aspect, the composition is a dietary ingredient and/or a dietary supplement. The composition may be a medical food or drug. In a related aspect, the composition is designated generally recognized as safe (GRAS) or as a new dietary ingredient (NDI).

[0055] As used herein, the term “nutraceutical” and “nutraceutically acceptable” are used to refer to any substance that is food or part of a food and provides medical and/or health benefits, including prevention and/or treatment of disease. Hence, compositions falling under the label of “nutraceutical” or “nutraceutically acceptable” may range from isolated nutrients, nutritional or dietary ingredients or dietary supplements and specific diets to genetically engineered designer foods, herbal products and processed foods such as beverages. In a more technical sense, the term has been used to refer to a product isolated or purified from foods, and generally sold in medicinal forms not associated with foods and demonstrated to have a physiological benefit or protection from chronic disease. The effect of the combined product as disclosed herein shows that the product supports the action of testosterone, which hormone promotes muscle development and build up. In addition, male sexual function may be enhanced as a result. Further, by aiding circulatory function, the action of the combined product as claimed aids in endurance during exercise. In one aspect, the combined product as claimed herein may be effective in increasing performance of athletes.

[0056] In a related aspect, the combined product as disclosed herein does not produce harmful side effects, while aiding in healthy heart effects.

[0057] In one aspect, the combined product helps maintain muscle mass as a subject grows older, as maintaining muscle mass is critical for overall fitness, coordination and hormonal balance as a subject ages. Further, as lack of growth hormone is associated with heart disease, and lack of testosterone is associated with erectile dysfunction, the combined product as disclosed herein helps with both conditions, including relieving the mental stress that may be associated with the latter.

[0058] In embodiments, the formulation of the combined product comprises H.sub.2, Co-Q10, vitamin C, vitamin D.sub.3, vitamin K, vitamin B.sub.6, folate, vitamin B.sub.12, magnesium, L-arginine, L-citrulline, red wine extract, a ginseng extract mix, and a trace mineral mix.

EXAMPLES

Example 1

Study

[0059] A study was carried out to analyze various metrics to determine the efficacy of the supplement.

[0060] No of Participants: 6

[0061] Ages: 34 yr.o (male: Subject A); 40 yr.o (male: Subject B); 45 yr.o (male: Subject C); 56 yr.o (female: Subject D); 40 yr.o (female: Subject E); 50 yr.o (female: Subject F).

[0062] Subject A XXL13 g/day (XXL+Co-Q10+hydrogen, 1 Serving) for 1 month every morning before work out; Subject B L-arginine (XXL−Co-Q10, −hydrogen) 13 g/day (1 Serving) for six (6) weeks every morning before workout; Subject C (placebo: natural yuzu flavor; natural pink lemonade; sweter; xylitol; citric acid, beet juice powder; organic stevia; natural flavor for strawberry powder; calcium silicate; and trace mineral bulk-powder) 13 g/day (1 Serving) for five (5) weeks every morning before workout; Subject D XXL (XXL+Co-Q10+hydrogen, 1 Serving) 13 g/day for seven (7) weeks every morning before workout; Subject E L-arginine (XXL−Co-Q10, −hydrogen) 13 g/day (1 Serving) for five (5) weeks every morning before workout; Subject F (placebo) 13 g/day (1 Serving) for four (4) weeks every morning before workout.

[0063] Subjects worked out a local gym, performing their normal routines (e.g., treadmill, free-weights, including using other fitness machines).

[0064] Participants used the following rating system to capture their personal observations to determine the effects of the supplement on their workouts: Performance (None=0 pts; Fair=1 pt; Good=2 pts; Excellent=3 pts); Strength (same ratings); Endurance (same ratings); Stamina (same ratings). The results are shown in Table 1 and FIG. 1.

TABLE-US-00001 TABLE 1 Results of Study Performance Strength Endurance Stamina Subject A 3 3 3 2 Subject B 1 1 1 1 Subject C 0 1 0 0 Subject D 3 2 3 3 Subject E 1 0 1 1 Subject F 1 0 0 1

[0065] As may be seen in Table 1 (and graphically in FIG.1), XXL+Co-Q10+hydrogen was observed to be the superior product across all metrics tested.

[0066] Although the invention has been described in the above example, it will be understood that modifications and variations are encompassed within the spirit and scope of the invention. Accordingly, the invention is limited only by the following claims.