Nutritional Intervention for Improving Muscular Function and Strength

• US 20100179112A1
• Filed: 12/09/2009
• Published: 07/15/2010
• Est. Priority Date: 12/09/2008
• Status: Active Grant

• Current Assignee: Metabolic Technologies, Inc. (MTI Biotech, Inc.)
• Original Assignee: Metabolic Technologies, Inc. (MTI Biotech, Inc.)
• Inventors: Baier, Shawn, Abumrad, Naji, Nissen, Steven, Rathmacher, John, Fuller, John JR.
• Granted Patent: US 8,815,280 B2
• Time in Patent Office: Days
• US Class Current: 514/167
• CPC Class Codes: A23L 33/10 using additives addition of substantially indigestible substances A23L33/21
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23L 33/155 Vitamins A or D
• 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 2200/316 having an effect on regeneration or building of ligaments or muscles
• CPC Class Codes: A23V 2250/71 Vitamin D
• 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 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/59 Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 21/06 Anabolic agents androgens A61P5/26
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals

Abstract

The present invention provides a composition comprising HMB and Vitamin D. Methods of administering HMB and Vitamin D to an animal are also described. Vitamin D and HMB are administered to increase muscle mass, strength, and functionality. The combination of Vitamin D and HMB together has a synergistic effect, which results in a surprising and unexpected level of improvement in muscle mass, strength and functionality.

Claims

1. A composition comprising from about 0.5 g to about 30 g of β

-hydroxy-β

-methylbutyric acid (HMB) and Vitamin D in an amount greater than about 500IU but not great enough to cause toxicity.

2. The composition of claim 1, wherein said HMB is selected from the group consisting of its free acid form, its salt, its ester, and its lactone.

3. The composition of claim 2, wherein said salt is selected from the group consisting of a sodium salt, a potassium salt, a magnesium salt, a chromium salt, and a calcium salt.

4. The composition of claim 3, wherein said salt is a calcium salt.

5. The composition of claim 2, wherein said ester is selected from the group consisting of methyl esters and ethyl esters.

6. The composition of claim 2, wherein said HMB is an HMB isovaryl lactone.

7. The composition of claim 1, further comprising Vitamin D from about 500IU to about 4000IU.

8. The composition of claim 1, wherein said Vitamin D is Vitamin D₃.

9. The composition of claim 1, wherein said Vitamin D is Vitamin D₂.

10. A composition comprising from about 0.5 g to about 30 g of β

-hydroxy-β

-methylbutyric acid (HMB) and Vitamin D in an amount sufficient to raise blood levels of Vitamin D to at least about 25 ng/ml.

11. The composition of claim 10, wherein said HMB is selected from the group consisting of its free acid form, its salt, its ester, and its lactone.

12. The composition of claim 11, wherein said salt is selected from the group consisting of a sodium salt, a potassium salt, a magnesium salt, a chromium salt, and a calcium salt.

13. The composition of claim 12, wherein said salt is a calcium salt.

14. The composition of claim 11, wherein said ester is selected from the group consisting of methyl esters and ethyl esters.

15. The composition of claim 11, wherein said HMB is an HMB isovaryl lactone.

16. The composition of claim 10, further comprising Vitamin D from about 500IU to about 4000IU.

17. The composition of claim 10, wherein said Vitamin D is Vitamin D₃.

18. The composition of claim 10, wherein said Vitamin D is Vitamin D₂.

19. The composition of claim 10, wherein said Vitamin D is present in an amount sufficient to raise blood levels of Vitamin D to at least about 30 ng/ml.

53. The method of claim 17, wherein said HMB is administered to said animal in an edible form.

54. The method of claim 53, wherein said edible form is a foodstuff.

20. A method for increasing muscle mass of an animal in need thereof comprising the steps of administering to said animal HMB and Vitamin D in amounts sufficient to increase muscle mass, wherein upon said administration of HMB and Vitamin D to the animal, said muscle mass is increased.

21. The method of claim 20, wherein said HMB is selected from the group consisting of its free acid form, its salt, its ester, and its lactone.

22. The method of claim 21, wherein said salt is selected from the group consisting of a sodium salt, a potassium salt, a magnesium salt, a chromium salt, and a calcium salt.

23. The method of claim 22, wherein said salt is a calcium salt.

24. The method of claim 21, wherein said ester is selected from the group consisting of methyl esters and ethyl esters.

25. The method of claim 21, wherein said HMB is an HMB isovaryl lactone.

26. The method of claim 20, further comprising Vitamin D from about 500IU to about 4000IU.

27. The method of claim 20, wherein said Vitamin D is Vitamin D₃.

28. The method of claim 20, wherein said Vitamin D is Vitamin D₂.

29. The method of claim 20, wherein said HMB is administered to said animal in an edible form.

30. The method of claim 29, wherein said edible form is a foodstuff.

31. The method of claim 20, wherein said HMB is administered to said animal intravenously.

32. A method for increasing strength of an animal in need thereof comprising the steps of administering to said animal HMB and Vitamin D in amounts sufficient to increase strength, wherein upon said administration of HMB and Vitamin D to the animal, said strength is increased.

33. The method of claim 32, wherein said HMB is selected from the group consisting of its free acid form, its salt, its ester, and its lactone.

34. The method of claim 33, wherein said salt is selected from the group consisting of a sodium salt, a potassium salt, a magnesium salt, a chromium salt, and a calcium salt.

35. The method of claim 34, wherein said salt is a calcium salt.

36. The method of claim 33, wherein said ester is selected from the group consisting of methyl esters and ethyl esters.

37. The method of claim 33, wherein said HMB is an HMB isovaryl lactone.

38. The method of claim 32, further comprising Vitamin D from about 500IU to about 4000IU.

39. The method of claim 32, wherein said Vitamin D is Vitamin D₃.

40. The method of claim 32, wherein said Vitamin D is Vitamin D₂.

41. The method of claim 32, wherein said HMB is administered to said animal in an edible fin in.

42. The method of claim 41, wherein said edible form is a foodstuff.

43. The method of claim 32 wherein said HMB is administered to said animal intravenously.

44. A method for improving muscle function of an animal in need thereof comprising the steps of administering to said animal HMB and Vitamin D in amounts sufficient to improve muscle function, wherein upon said administration of HMB and Vitamin D to the animal, said muscle function is improved.

45. The method of claim 44, wherein said HMB is selected from the group consisting of its free acid form, its salt, its ester, and its lactone.

46. The method of claim 45, wherein said salt is selected from the group consisting of a sodium salt, a potassium salt, a magnesium salt, a chromium salt, and a calcium salt.

47. The method of claim 46, wherein said salt is a calcium salt.

48. The method of claim 45, wherein said ester is selected from the group consisting of methyl esters and ethyl esters.

49. The method of claim 45, wherein said HMB is an HMB isovaryl lactone.

50. The method of claim 44, further comprising Vitamin D from about 500IU to about 4000IU.

51. The method of claim 44, wherein said Vitamin D is Vitamin D₃.

52. The method of claim 44, wherein said Vitamin D is Vitamin D₂.

55. The method of claim 44, wherein said HMB is administered to said animal intravenously.