Compositions, methods, and kits for regulating energy metabolism

• US 9,408,410 B2
• Filed: 10/29/2015
• Issued: 08/09/2016
• Est. Priority Date: 03/08/2012
• Status: Active Grant

• Current Assignee: Nusirt Sciences, Inc.
• Original Assignee: Nusirt Sciences, Inc.
• Inventors: Zemel, Michael B., Grindstaff, E. Douglas II
• Primary Examiner(s): LOVE, TREVOR M
• Application Number:
  US14/927,228
• Publication Number:
  US 20160113317A1
• Time in Patent Office: 285 Days
• US Class Current: 1/1
• 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 solid composition comprising:

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

(b) at least about 0.1 mg of vitamin B6;

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

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

wherein the composition is free of the individual amino acid arginine, alanine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, and valine.

2. The composition of claim 1, wherein the composition is packaged as a unit dosage.

3. The composition 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.

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

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

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

7. The composition of claim 1, wherein the composition is formulated as a tablet, capsule, or gel capsule.

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

9. The composition of claim 1, further comprising one or more of a sweetener, a bulking agent, a stabilizer, an acidulant, and a preservative.

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

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

12. The composition of claim 1, wherein the composition further comprises metformin.

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

14. A method for increasing energy metabolism in a subject in need thereof comprising administering a composition of claim 1 to the subject to effect an increase in the subject'"'"'s energy metabolism.

15. A method for enhancing fat oxidation in a subject in need thereof comprising administering the composition of claim 1 at least two times per day to effect an increase in the subject'"'"'s fat oxidation.

16. A method for increasing energy metabolism in a subject comprising:

administering a unit dosage of the composition of claim 1 at a selected dosing level, wherein the selected dosing level induces a circulating level of about 0.5 mM leucine and about 100 nM B6 in the subject.