Compositions, methods, and kits for regulating energy metabolism

• US 9,198,454 B2
• Filed: 10/26/2012
• Issued: 12/01/2015
• Est. Priority Date: 03/08/2012
• Status: Active Grant

• Current Assignee: Nusirt Sciences, Inc.
• Original Assignee: Nusirt Sciences, Inc.
• Inventors: Zemel, Michael, Grindstaff, E. Douglas II
• Primary Examiner(s): LOVE, TREVOR M
• Application Number:
  US13/662,345
• Publication Number:
  US 20130237605A1
• Time in Patent Office: 1,131 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 liquid composition comprising:

(a) at least about 250 mg of leucine and/or a leucine metabolite per 16 ounces of the liquid composition; and

(b) 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 about 65, wherein the composition comprises less than 1% of the individual amino acids isoleucine and valine, and is free of the individual amino acid arginine.

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 about 250 mg, and component (b) is present in an amount of at least about 0.1 mg.

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

5. The composition of claim 1, wherein the composition is a dietary supplement packaged as a beverage.

6. The composition of claim 1, wherein the composition comprises less than about 1% of the individual amino acids methionine and tryptophan.

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

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

9. The composition of claim 1, wherein the composition is in a container and is nonperishable at room temperature for at least one hour after opening.

10. 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.

11. The liquid composition of claim 1, wherein the liquid composition comprises less than 0.1% of the individual amino acid glycine.