# US 5,348,979 A · Method of promoting nitrogen retention in humans > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,348,979 A - Document ID: US5348979A - Status: Granted - Kind: A - Application number: 07/996,187 - Filed: 1992-12-23 - Granted: 1994-09-20 - Earliest claimed: 1992-12-23 - Assignees: Iowa State University Research Foundation, Inc.; Vanderbilt University - Inventors: Steven L. Nissen; Paul J. Flakoll; Naji N. Abumrad - Web page: https://patentgrep.com/patent/US5348979A ## CPC - A61K 31/22: of acyclic acids, e.g. pravastatin - A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60) - A61K 31/365: Lactones - A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00) - A61P 3/14: for calcium homeostasis (vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04) - 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 Nitrogen retention in human subjects is promoted by administering .beta.-hydroxy-.beta.-methylbutyric acid (HMB). The amount of HMB administered is effective to conserve protein as determined by reduction in urinary nitrogen. The method can be used with patients having a negative nitrogen balance due to disease conditions, and also with normal elderly persons who are subject to protein loss. The HMB may be administered orally or by intravenous infusion. ## Claims ### Claim 1 The method of protein sparing, comprising orally or intravenously administering to a human subject an effective amount of .beta.-hydroxy-.beta.-methylbutyric acid (HMB) for increasing the retention of nitrogen, said HMB being in an edible or intravenously-administrable form selected from (i) its free acid form, (ii) its sodium, potassium, or calcium salt, (iii) its methyl or ethyl ester, or (iv) its lactone, and continuing the said administration of HMB until the amount of nitrogen in the patient's urine has substantially decreased. ### Claim 2 (depends on 1) The method of claim 1 in which said HMB is in the form of its calcium salt (Ca-HMB) or its sodium salt (Na-HMB). ### Claim 3 (depends on 1, 2) The method of claims 1 or 2 in which said effective amount of HMB is within the range from 0.01 to 0.20 grams of said HMB based on its calcium salt per kilogram body weight per 24 hours. ### Claim 4 (depends on 1, 2) The method of claims 1 or 2 in which said HMB is administered orally. ### Claim 5 (depends on 1, 2) The method of claims 1 or 2 in which said HMB is administered by intravenous infusion. ### Claim 6 The method of treating an adult human patient having a negative nitrogen balance, comprising orally or intravenously administering to the patient from 0.5 to 10 grams per 24 hours of .beta.-hydroxy-.beta.-methylbutyric acid (HMB) based on its calcium salt, said HMB being in an edible or intravenously-administrable form selected from (i) its free acid form, (ii) its sodium, potassium, magnesium, or calcium salt, (iii) its methyl or ethyl ester, or (iv) its lactone, and continuing the said administration of HMB until the loss of nitrogen is substantially reduced as determined by nitrogen analysis of the patient's urine. ### Claim 7 (depends on 6) The method of claim 6 in which said HMB is in the form of its calcium salt (Ca-HMB). ### Claim 8 (depends on 6) The method of claim 6 in which said HMB is in the form of its sodium salt (Na-HMB). ### Claim 9 (depends on 6, 7, 8) The method of claims 6,7 or 8 in which said HMB is administered orally to the human patient in an amount of from 2 to 6 grams per 24 hours based on its calcium salt. ### Claim 10 (depends on 6, 7, 8) The method of claims 6, 7 or 8 in which said HMB is administered by intravenous infusion in an amount of 2 to 6 grams per 24 hours. ### Claim 11 The method of improving protein nutrition in elderly human subjects, comprising including in the daily diets of the human subjects an amount of from 0.5 to 10 grams per 24 hours of .beta.-hydroxy-.beta.-methylbutyric acid (HMB) based on its calcium salt, said HMB being in an edible form selected from (i) its free acid form, (ii) its sodium, potassium, or calcium salt, (iii) its methyl or ethyl ester, or (iv) its lactone, said amount of said HMB incorporated in said diets being effective to reduce the urinary nitrogen losses of the subjects. ### Claim 12 (depends on 11) The method of claim 11 in which said HMB is in the form of its calcium salt (Ca-HMB). ### Claim 13 (depends on 11, 12) The method of claims 11 or 12 in which the amount of HMB incorporated in said daily diets is from 2 to 6 grams per 24 hours. ### Claim 14 The method of treating a human patient who is receiving an intravenous therapy and is subject to excessive loss of nitrogen, comprising incorporating in an intravenous solution being given to the human patient an effective amount of HMB for reducing urinary nitrogen, said HMB being in an intravenously administerable form selected from Ca-HMB or Na-HMB.