Effects of Branch Chain Amino Acids on Glucose Tolerance in Obese Pre-Diabetic Subjects

Completed · Not applicable

Conditions studied: Prediabetic State

In brief

Branching chain amino acids (BCAA) have both beneficial and detrimental effects of on metabolism have been established and therefore warrants further investigation. In the preliminary study, the investigators found that BCAAs enhanced glucose metabolism in lean mice while they promoted glucose intolerance in obese mice. In lean mice, BCAAs decreased adiposity and enhanced glucose utilization and insulin sensitivity in different tissues. But in obese mice, BCAAs' effects were mediated by impaired insulin signaling in fat tissue. This study will examine 10 obese subjects with pre-diabetes and examine the effects of taking BCAA supplement and will monitor the subjects blood glucose, insulin, triglyceride levels and will have an oral glucose tolerance test on repeated occasions to see if any changes are noted in their glucose regulation.

Key facts

Study ID

NCT02684565

Run by

University of California, Los Angeles

People needed

11

Starts

2016-10-01

Expected to finish

2018-02-01

Last updated by the study team

2018-02-12

Who can join

Age: 20 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 20-50 years of age at screen
• BMI between 27 to 35
• Fasting glucose level >100, but <126 mg/dL or HgbA1c >5.7% but < 6.4%
• Waist circumference > 40 cm in men and >35 in 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

• University of California, Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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