Investigation of an Amino Acid Supplement on Glucose Levels in Obese Subjects

Completed · Not applicable · Has a placebo group

Conditions studied: Pre-diabetes, Obese, Glucose Intolerance

In brief

This study aims to determine whether the use of Branched-Chain Amino Acids (BCAA's) regulate insulin and glucagon secretion, and whether the supplement has any effect on body weight and body composition. Subjects who participate in this study will receive an 8-week supply of supplement. The study supplements will be manufactured by Scientific Living, in Irvine, CA for high dose BCAA and the low dose BCAA is manufactured by Nutribiotic, Lakeport, CA. Timed blood collections will be used to measure how BCAA affect glucose metabolism/insulin sensitivity in human subjects.

Key facts

Study ID

NCT03715010

Run by

University of California, Los Angeles

People needed

14

Starts

2016-03-18

Expected to finish

2018-01-19

Last updated by the study team

2019-09-20

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 20-65 years of age at screen
• BMI between 27 to 40
• Fasting glucose level >100, but <126 mg/dL or HgbA1c >5.7% but < 6.4%
• Waist circumference > 40 in for men and >35 in for women
• Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.

You may not qualify if…

• Any subject with a history of diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, cancer (except skin basal cell carcinoma ) chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
• Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
• Any subject who currently uses tobacco products.
• Any history of gastrointestinal disease except for appendectomy.
• Any antibiotic or laxative use during the 2 months before the study.
• Any subject who is unable or unwilling to comply with the study protocol.
• Any subject allergic to soy products.

Where it is running

• UCLA Center for Human Nutriiton — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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