# US 8,785,496 B2 · Method of using beta-hydroxy-beta-methylbutyrate for treating disease-associated wasting

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- Number: US 8,785,496 B2
- Document ID: US8785496B2
- Status: Granted
- Kind: B2
- Application number: 13/348,024
- Filed: 2012-01-11
- Published: 2012-07-26
- Granted: 2014-07-22
- Earliest claimed: 2004-03-26
- Assignees: Abbott Laboratories
- Applicants: Jeffrey H. Baxter; Anne C. Voss; Pradip Mukerji
- Inventors: Jeffrey H. Baxter; Anne C. Voss; Pradip Mukerji
- Web page: https://patentgrep.com/patent/US8785496B2

## CPC

- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/12: Antidiarrhoeals
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/12: for electrolyte homeostasis
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 13/12: of the kidneys
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/18: for HIV
- A61P 35/00: Antineoplastic agents
- A61P 37/00: Drugs for immunological or allergic disorders
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to methods for the prevention and treatment of chronic inflammatory diseases, cancer, and involuntary weight loss. In the practice of the present invention patients are enterally administered HMB alone or alternatively in combination with eicosapentaenoic (20:5 ω-3), FOS, carnitine and mixtures thereof. HMB may be added to food products comprising a source of amino-nitrogen enriched with large neutral amino acids such as leucine, isoleucine, valine, tyrosine, threonine and phenylalanine and substantially lacking in free amino acids.

## Claims

### Claim 1

A method of treating disease-associated wasting of a patient comprising administering to the patient a composition comprising:
a. beta-hydroxy-beta-methylbutyrate, its salts, metabolites or derivatives thereof;
b. carnitine; and
c. an amino nitrogen source enriched with large neutral amino acids;
wherein the composition is substantially lacking in free amino acids; and
wherein the disease-associated wasting is associated with a disease selected from the group consisting of cachexia, cancer, age-associated wasting, wasting associated with long-term hospital stay, HIV/AIDS, arthritis, trauma, liver disease, Crohn's disease, inflammatory bowel diseases, renal insufficiency, and chronic obstructive pulmonary disease.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the beta-hydroxy-beta-methylbutyrate is selected from the group consisting of sodium beta-hydroxy-beta-methylbutyrate, potassium beta-hydroxy-beta-methylbutyrate, magnesium beta-hydroxy-beta-methylbutyrate, chromium beta-hydroxy-beta-methylbutyrate, calcium beta-hydroxy-beta-methylbutyrate, alkali metal beta-hydroxy-beta-methylbutyrate, alkaline earth metal beta-hydroxy-beta-methylbutyrate and beta-hydroxy-beta-methylbutyrate lactone.

### Claim 3 (depends on 2)

The method according to claim 2, wherein the beta-hydroxy-beta-methylbutyrate is calcium beta-hydroxy-beta-methylbutyrate.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the composition comprises at least 2 grams beta-hydroxy-beta-methylbutyrate in a daily serving.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the composition further comprises omega-3 fatty acids.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the omega-3 fatty acids are selected from the group consisting of alpha-linolenic acid, stearidonic acid, eicosapentaenoic acid, docosapentaenoic acid and docosahexaenoic acid.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the omega-3 fatty acids are eicosapentaenoic acid.

### Claim 8 (depends on 7)

The method according to claim 7, wherein the composition comprises at least 0.5 grams eicosapentaenoic acid in a daily serving.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the composition comprises at least 1.0 grams eicosapentaenoic acid in a daily serving.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the large neutral amino acids comprise at least 10% of the amino nitrogen source.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the free amino acids comprise less than 0.4 grams per serving of the composition.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the composition comprises less than 2 grams of carnitine in a daily serving.

### Claim 13 (depends on 1)

The method according to claim 1, wherein the composition further comprises an indigestible oligosaccharide.

### Claim 14 (depends on 13)

The method according to claim 13, wherein the indigestible oligosaccharide is fructooligosaccharide.

### Claim 15 (depends on 14)

The method according to claim 14, wherein the composition comprises at least 1 gram of fructooligosaccharide in a daily serving.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the composition comprises from about 2 grams to about 4 grams of fructooligosaccharide in a daily serving.

### Claim 17 (depends on 1)

The method according to claim 1, wherein the composition further comprises a nutrient selected from the group consisting of vitamins, minerals, and trace minerals.

### Claim 18 (depends on 1)

The method according to claim 1, wherein the composition further comprises at least one antioxidant selected from the group consisting of beta-carotene, vitamin E, vitamin C, and selenium.

### Claim 19 (depends on 1)

The method according to claim 1, wherein the composition is administered to a human.

### Claim 20 (depends on 1)

The method according to claim 1, wherein the composition is selected from the group consisting of a dietary supplement, meal replacement, nutritional bar, chew or bite and beverage.
