Composition comprising .beta.-hydroxy-.beta.-methylbutyric acid and at least one amino acid and methods of use

• US 6,031,000 A
• Filed: 06/23/1998
• Issued: 02/29/2000
• Est. Priority Date: 06/23/1998
• Status: Expired due to Term

• Current Assignee: Iowa State University Research Foundation Incorporated (Iowa State University)
• Original Assignee: Iowa State University Research Foundation Incorporated (Iowa State University)
• Inventors: Abumrad, Naji M., Nissen, Steven L.
• Primary Examiner(s): HENLEY III, RAYMOND J
• Application Number:
  US09/102,941
• Time in Patent Office: 616 Days
• Field of Search: 514/557, 514/561, 514/565
• US Class Current: 514/557
• 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 31/195 having an amino group
• CPC Class Codes: A61K 31/22 of acyclic acids, e.g. pravastatin
• CPC Class Codes: A61K 31/365 Lactones
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• 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 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention provides a composition comprising HMB and at least one amino acid. The present invention also provides a method for the treatment of disease-associated wasting of an animal, a method for decreasing the serum-level of triglycerides of an animal, a method for decreasing the serum viral load of an animal, and a method for redistributing fat in an animal having a visceral region and a subcutaneous region. All methods comprise administering to the animal a composition comprising HMB and at least one amino acid.

Claims

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

-hydroxy-β

-methylbutyric acid (HMB), wherein said from about 0.5 g to about 30 g is based on the weight of the calcium salt of HMB, from about 0.5 g to about 50 g of L-arginine, and from about 0.5 g to about 50 g of L-glutamine.

2. The composition of claim 1, which comprises from about 0.5 g to about 20 g of HMB, wherein said from about 0.5 g to about 20 g is based on the weight of the calcium salt of HMB, from about 1 g to about 30 g of L-arginine, and from about 1 g to about 30 g of L-glutamine.

3. The composition of claim 2, which comprises from about 0.5 g to about 10 g of HMB, wherein said from about 0.5 g to about 10 g is based on the weight of the calcium salt of HMB, from about 2 g to about 20 g of L-arginine, and from about 2 g to about 20 g of L-glutamine.

4. A method for the treatment of disease-associated wasting of an animal, which method comprises administering to said animal a composition comprising HMB and at least one amino acid in amounts sufficient to treat said disease-associated wasting, wherein, upon administration of the composition to the animal, said disease-associated wasting is treated.

5. The method of claim 4, wherein said HMB is in a form selected from the group consisting of a free acid, a salt, an ester, and a lactone.

6. The method of claim 5, wherein said HMB is in the form of a salt.

7. The method of claim 6, wherein said HMB is in the form of a salt selected from the group consisting of a sodium salt, a potassium salt, a magnesium salt, a chromium salt, and a calcium salt.

8. The method of claim 7, wherein said HMB is in the form of a calcium salt.

9. The method of claim 5, wherein said HMB is in the form of an ester.

10. The method of claim 9, wherein said HMB is in the form of an ester selected from the group consisting of a methyl ester and an ethyl ester.

11. The method of claim 6, wherein said HMB is in the form of a lactone.

12. The method of claim 11, wherein said HMB is in the form of an isovalaryl lactone.

13. The method of claim 4, wherein said at least one amino acid is selected from the group consisting of L-arginine, L-glutamine, L-lysine, L-leucine, L-isoleucine, L-valine, L-methionine, L-cysteine, glycine, and combinations thereof.

14. The method of claim 13, wherein said at least one amino acid is the combination of L-arginine and L-glutamine.

15. The method of claim 14, wherein said HMB is in the form of a calcium salt and said at least one amino acid is the combination of L-arginine and L-glutamine.

16. The method of claim 14, wherein said HMB and said at least one amino acid are present in amounts sufficient to increase the lean tissue mass of said animal by at least 10 g per day.

17. The method of claim 4, wherein said HMB is present in an amount from about 0.5 g to about 30 g and said amount of at least one amino acid is present in an amount from about 1 g to about 100 g.

18. The method of claim 4, wherein said disease-associated wasting is that which is associated with cancer, chronic pulmonary disease, age, chronic kidney disease, long-term hospitalization that restricts the animal'"'"'s mobility, or AIDS.

19. The method of claim 18, wherein said disease-associated wasting is associated with AIDS.

20. The method of claim 4, wherein said composition comprises from about 0.5 g to about 30 g of HMB, wherein said from about 0.5 g to about 30 g is based on the weight of the calcium salt of HMB, from about 0.5 g to about 50 g of L-arginine, and from about 0.5 g to about 50 g of L-glutamine.

21. The method of claim 20, wherein said composition comprises from about 0.5 g to about 20 g of HMB, wherein said from about 0.5 g to about 20 g is based on the weight of the calcium salt of HMB, from about 1 g to about 30 g of L-arginine, and from about 1 g to about 30 g of L-glutamine.

22. The method of claim 21, wherein said composition comprises from about 0.5 g to about 10 g of HMB, wherein said from about 0.5 g to about 10 g is based on the weight of the calcium salt of HMB, from about 2 g to about 20 g of L-arginine, and from about 2 g to about 20 g of L-glutamine.

23. A method for decreasing the serum-level of triglycerides of an animal, which method comprises administering to said animal a composition comprising HMB and at least one amino acid in amounts sufficient to decrease the serum-level of triglycerides of said animal, wherein, upon administration of the composition to the animal, the serum-level of triglycerides of said animal is decreased.

24. The method of claim 23, wherein said HMB is in a form selected from the group consisting of a free acid, a salt, an ester, and a lactone.

25. The method of claim 24, wherein said HMB is in the form of a salt.

26. The method of claim 25, wherein said HMB is in the form of a salt selected from the group consisting of a sodium salt, a potassium salt, a magnesium salt, a chromium salt, and a calcium salt.

27. The method of claim 26, wherein said HMB is in the form of a calcium salt.

28. The method of claim 24, wherein said HMB is in the form of an ester.

29. The method of claim 28, wherein said HMB is in the form of an ester selected from the group consisting of a methyl ester and an ethyl ester.

30. The method of claim 24, wherein said HMB is in the form of a lactone.

31. The method of claim 30, wherein said HMB is in the form of an isovalaryl lactone.

32. The method of claim 23, wherein said at least one amino acid is selected from the group consisting of L-arginine, L-glutamine, L-lysine, L-leucine, L-isoleucine, L-valine, L-methionine, L-cysteine, glycine, and combinations thereof.

33. The method of claim 32, wherein said at least one amino acid is the combination of L-arginine and L-glutamine.

34. The method of claim 23, wherein said HMB is in the form of a calcium salt and said at least one amino acid is the combination of L-arginine and L-glutamine.

36. The method of claim 31, wherein said HMB is in a form selected from the group consisting of a free acid, a salt, an ester, and a lactone.

37. The method of claim 36, wherein said HMB is in the form of a salt.

38. The method of claim 37, wherein said HMB is in the form of a salt selected from the group consisting of a sodium salt, a potassium salt, a magnesium salt, a chromium salt, and a calcium salt.

39. The method of claim 38, wherein said HMB is in the form of a calcium salt.

40. The method of claim 36, wherein said HMB is in the form of an ester.

41. The method of claim 40, wherein said HMB is in the form of an ester selected from the group consisting of a methyl ester and an ethyl ester.

42. The method of claim 36, wherein said HMB is in the form of a lactone.

43. The method of claim 42, wherein said HMB is in the form of an isovalaryl lactone.

35. A method for decreasing the serum viral load of an animal, which method comprises administering to said animal a composition comprising HMB and at least one amino acid in amounts sufficient to decrease the serum viral load of said animal, wherein, upon administration of the composition to the animal, the serum viral load of said animal is decreased.

44. The method of claim 35, wherein said at least one amino acid is selected from the group consisting of L-arginine, L-glutamine, L-lysine, L-leucine, L-isoleucine, L-valine, L-methionine, L-cysteine, glycine, and combinations thereof.

45. The method of claim 44, wherein said at least one amino acid is the combination of L-arginine and L-glutamine.

46. The method of claim 35, wherein said HMB is in the form of a calcium salt and said at least one amino acid is the combination of L-arginine and L-glutamine.

47. A method for redistributing fat in an animal having a visceral region and a subcutaneous region, which method comprises administering to said animal a composition comprising HMB and at least one amino acid in amounts sufficient to redistribute fat from the visceral region of said animal to the subcutaneous region of said animal, wherein, upon administration of the composition to the animal, the fat from the visceral region of said animal is redistributed to the subcutaneous region of said animal.

48. The method of claim 47, wherein said HMB is in a form selected from the group consisting of a free acid, a salt, an ester, and a lactone.

49. The method of claim 48, wherein said HMB is in the form of a salt.

50. The method of claim 49, wherein said HMB is in the form of a salt selected from the group consisting of a sodium salt, a potassium salt, a magnesium salt, a chromium salt, and a calcium salt.

51. The method of claim 50, wherein said HMB is in the form of a calcium salt.

52. The method of claim 48, wherein said HMB is in the form of an ester.

53. The method of claim 52, wherein said HMB is in the form of an ester selected from the group consisting of a methyl ester and an ethyl ester.

54. The method of claim 48, wherein said HMB is in the form of a lactone.

55. The method of claim 54, wherein said HMB is in the form of an isovalaryl lactone.

56. The method of claim 47, wherein said at least one amino acid is selected from the group consisting of L-arginine, L-glutamine, L-lysine, L-leucine, L-isoleucine, L-valine, L-methionine, L-cysteine, glycine, and combinations thereof.

57. The method of claim 56, wherein said at least one amino acid is the combination of L-arginine and L-glutamine.

58. The method of claim 47, wherein said HMB is in the form of a calcium salt and said at least one amino acid is the combination of L-arginine and L-glutamine.