Compositions, methods, and kits for regulating energy metabolism

• US 9,901,573 B2
• Filed: 06/09/2017
• Issued: 02/27/2018
• Est. Priority Date: 03/08/2012
• Status: Active Grant

• Current Assignee: Nusirt Sciences, Inc.
• Original Assignee: Nusirt Sciences, Inc.
• Inventors: Zemel, Michael, Grindstaff, II, E. Douglas
• Primary Examiner(s): LOVE, TREVOR M
• Application Number:
  US15/619,374
• Publication Number:
  US 20170368045A1
• Time in Patent Office: 263 Days
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23L 33/175 Amino acids
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/332 Promoters of weight control and weight loss
• CPC Class Codes: A23V 2250/0628 Leucine
• CPC Class Codes: A23V 2250/7052 Vitamin B6
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/191 having two or more hydroxy groups, e.g. gluconic acid
• CPC Class Codes: A61K 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• CPC Class Codes: A61K 31/198 Alpha-amino acids, e.g. alanine or edetic acid [EDTA] betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00
• CPC Class Codes: A61K 31/4415 Pyridoxine, i.e. Vitamin B6 pyridoxal phosphate A61K31/675
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin

Abstract

The present invention provides for compositions, methods and kits for regulating energy metabolism. In one aspect, the invention provides for compositions that comprise a combination of (a) branched chain amino acids, such as leucine, and (b) vitamin B6, or any precursors or metabolites of (a) or (b). These combinations may be synergistic and/or effective for reducing weight or adipose volume. In another aspect, the invention provides for methods of regulating energy metabolism by the administration of one or more compositions comprising branched chain amino acids and vitamin B6. The invention also provides for kits comprising compositions of branched chain amino acids and vitamin B6 packaged in an oral dose form with usage instructions.

Claims

1. A kit comprising:

i. a composition consisting of;

a. at least 250 mg of leucine and/or a leucine metabolite;

b. at least about 0.1 mg of vitamin B6; and

c. at least one additional ingredient;

wherein the leucine metabolite is selected from the group consisting of keto-isocaproic acid (KIC), alpha-hydroxy-isocaproic acid, and hydroxymethylbutyrate (HMB),

wherein (a) and (b) comprise at least 50% of the composition,

wherein the composition comprises less than 1% of the individual amino acids alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, and valine, and

wherein the mass ratio of component (a) to (b) in said composition is greater than 65, and

ii. instructions.

2. The kit of claim 1, wherein component (a) is present in an amount of at least 1130 mg, and component (b) is present in an amount of at least 12 mg.

3. The kit of claim 1, wherein the composition comprises at least 500 mg of leucine and at least 5 mg of vitamin B6.

4. The kit of claim 1, wherein the mass ratio of component (a) to (b) in the composition is less than 100.

5. The kit of claim 1, wherein the kit further comprises a pharmaceutically active agent or an anti-diabetic agent.

6. The kit of claim 5, wherein the anti-diabetic agent comprises metformin.

7. The kit of claim 1, wherein the composition is formulated as an oral dosage form.

8. The kit of claim 1, wherein the composition is a dietary supplement packaged as a solid food or a semi-solid food.

9. The kit of claim 8, wherein the composition is formulated as a tablet, capsule, or gel capsule.

10. The kit of claim 1, wherein the composition further comprises a food carrier.

11. The kit of claim 1, wherein the composition further comprises one or more of a sweetener, a bulking agent, a stabilizer, an acidulant, and a preservative.

12. The kit of claim 1, wherein the composition has a shelf-life greater than 7 months.

13. The kit of claim 1, wherein the composition is packaged as a liquid composition.

14. The kit of claim 13, wherein the composition comprises at least about 250 mg of the leucine or leucine metabolite per 16 ounces of the liquid composition.

15. The kit of claim 1, wherein component (a) and (b) are provided in a single composition.

16. The kit of claim 1, wherein component (a) is provided in a separate composition from component (b).

17. A method for treating obesity in a subject in need thereof comprising administering a composition consisting of:

a. at least 250 mg of leucine and/or a leucine metabolite;

b. at least about 0.1 mg of vitamin B6; and

c. at least one additional ingredient;

wherein the leucine metabolite is selected from the group consisting of keto-isocaproic acid(KIC), alpha-hydroxy-isocaproic acid, and hydroxymethylbutyrate (HMB),

wherein (a) and (b) comprise at least 50% of the composition,

wherein the composition comprises less than 1% of the individual amino acids alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, and valine,

and wherein the mass ratio of component (a) to (b) in said composition is greater than 65.

18. The method of claim 17, wherein treating obesity is characterized by a decrease in weight gain of the subject, a decrease in adipose volume of the subject, and/or an increase in fat oxidation of a subject.

19. The method of claim 17, wherein the composition is administered to the subject twice a day.

20. The method of claim 17, wherein the composition is administered to the subject once a day.

21. The method of claim 17, wherein the subject in need thereof is human.

22. The method of claim 17, wherein the composition further comprises a pharmaceutically active agent or an anti-diabetic agent.

23. The method of claim 22, wherein the anti-diabetic agent comprises metformin.

24. The method of claim 17, wherein component (a) and (b) are taken by the subject in any order.

25. The method of claim 17, wherein component (a) and (b) are taken by the subject simultaneously.