Method for the prevention and treatment of cachexia and anorexia

• US 6,326,355 B1
• Filed: 01/07/2000
• Issued: 12/04/2001
• Est. Priority Date: 04/25/1996
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Cope, Frederick Oliver, Abbruzzese, Bonnie Chandler, McCamish, Mark Anthony, Demichele, Stephen Joseph
• Primary Examiner(s): CHANG, CELIA C
• Application Number:
  US09/479,550
• Time in Patent Office: 697 Days
• Field of Search: 424/523, 426/72, 426/601, 426/602, 426/656, 426/800, 426/801, 514/21, 514/578, 514/725, 514/730, 514/739
• US Class Current: 514/23
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23L 33/16 Inorganic salts, minerals or trace elements
• CPC Class Codes: A23L 33/175 Amino acids
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/02 Antioxidant
• CPC Class Codes: A23V 2200/30 Foods, ingredients or supplements having a functional effect on health
• CPC Class Codes: A23V 2200/308 having an effect on cancer prevention
• CPC Class Codes: A23V 2250/1626 Selenium
• CPC Class Codes: A23V 2250/1868 Docosahexaenoic acid
• CPC Class Codes: A23V 2250/187 Eicosapentaenoic acid
• CPC Class Codes: A23V 2250/211 Carotene, carotenoids
• CPC Class Codes: A23V 2250/5046 Fructan
• CPC Class Codes: A23V 2250/708 Vitamin C
• CPC Class Codes: A23V 2250/712 Vitamin E
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/70 Carbohydrates; Sugars; Derivatives thereof sorbitol A61K31/047
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 9/0029 Parenteral nutrition; Parenteral nutrition compositions as drug carriers
• 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 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/04 : Immunostimulants
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/00 : Drugs for disorders of the blood or the extracellular fluid
• CPC Class Codes: Y10S 426/80 : Geriatric
• CPC Class Codes: Y10S 426/801 : Pediatric

Abstract

The present invention relates to methods and nutritional compositions for the prevention and treatment of cachexia and anorexia. The methods of the invention comprise administering a composition comprising effective amounts of ω-3 fatty acids such as alpha-linolenic acid, stearidonic acid, eicosapentaenoic acid, docosapentaenoic acid, docosahexaenoic acid or mixtures thereof, of branched-chain amino acids valine, leucine, isoleucine or mixtures thereof; with or without reduced levels of tryptophan and 5-hydroxytryptophan; and of antioxidant system selected from the group comprising beta-carotene, vitamin C, vitamin E, selenium, or mixtures thereof.

Claims

1. A method of preventing the onset of cancer cachexia or treating existing cancer cachexia in a human, said method comprising enterally administering to the human on a daily basis a liquid nutritional matrix containing:

(a) an oil blend containing n-6 fatty acids and at least 450 mg of n-3 fatty acids, the weight ratio of n-6 fatty acids to n-3 fatty acids being from about 0.1 to about 1; and

said oil blend provides from about 10% to about 35% of the total calories of said nutritional;

(b) a source of amino-nitrogen wherein 15% to 50% by weight of the amino acids of said source of amino-nitrogen are branched-chain amino acids, and said source of amino nitrogen provides from about 12% to about 24% of the total calories of said nutritional;

(c) an antioxidant component comprised of at least one nutrient selected from the group comprising beta-carotene, vitamin C, vitamin E, selenium, or mixtures thereof, and;

(d) a source of carbohydrate providing from about 40% to about 65% of the total calories of said nutritional.

2. The method according to claim 1, further comprising administering to the human a source of amino-nitrogen wherein tryptophan is present in an amount of less than about 5.0% by weight of the total amount of the amino acids present in said source of amino-nitrogen.

3. The method according to claim 1, further comprising administering to the human a source of amino-nitrogen wherein 15% to 25% by weight of the amino acids of said source of amino-nitrogen are branched-chain amino acids.

4. The method according to claim 1 which further comprises daily administering to the human;

(a) an oil blend containing ω

-6 fatty acids and at least 1000 mg of ω

-3 fatty acids, and

(b) a source of amino-nitrogen wherein 15% to 25% by weight of the amino acids are branched-chain amino acids, and wherein tryptophan is present in an amount of less than 3.0% by weight of the total amount of the amino acids present in said source of amino-nitrogen; and

(c) an antioxidant mixture comprising beta-carotene, vitamin C, vitamin E and selenium.

5. The method of claim 4 wherein the antioxidant system of component (c) comprises about 2,500 to about 6,500 micrograms beta-carotene, about 250 to about 1,000 milligrams vitamin C, about 100 to about 500 I.U. vitamin E and about 75 to about 125 micrograms selenium per liter.

6. The method of claim 1 in which the ω

-3 fatty acids comprise from about 15 to about 30% by weight of the total fatty acids and are selected from the group consisting of alpha-linolenic acid, stearidonic acid, eicosapentaenoic acid, docosapentaenoic acid and docosahexaenoic acid.

7. The method of claim 6 in which the ω

-3 fatty acids comprise from about 15 to about 40% by weight of the total fatty acids and are selected from the group consisting of eicosapentaenoic acid and docosahexaenoic acid.

8. The method of claim 7 in which at least about 15% by weight of the total fatty acids is eicosapentaenoic acid.

9. The method of claim 1 wherein about 15% to about 25% by weight of the amino acids of said source of amino-nitrogen are branched-chain amino acids;

and said antioxidant component comprises a mixture of beta-carotene, vitamin C, vitamin E and selenium.

10. The method according to claim 1 which further comprises daily administering to the human:

(a) an oil blend containing ω

-6 fatty acids and at least 1000 mg of ω

-3 fatty acids, and

(b) a source of amino-nitrogen wherein 15% to 25% by weight of the amino acids are branched-chain amino acids, and wherein tryptophan is present in an amount of less than 5.0% by weight of the total amount of the amino acids present in said source of amino-nitrogen.

11. The method of claim 10 comprising feeding eicosapentaneoic acid as the ω

-3 fatty acid.

12. The method according to claim 7 in which the human receives at least 3 grams per day of a fatty acid selected from the group consisting of eicosapentaenoic acid and docosahexaenoic acid.

13. The method according to claim 12 in which the human receives at least 5 grams per day of branched chain amino acids.