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

NCT03715010 | Completed

• 1 other identifier: 15-001928
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-diabetes; Obese; Glucose Intolerance

Outcome Measures

Primary Outcomes (1)

• Measure of glucose AUC during 2H OGTT (Frame: 10 weeks)

  To assess change of glucose AUC during 2H OGTT test

  Baseline week4, week6 and 10 weeks

Secondary Outcomes (1)

• Measure of body composition (Time Frame: 10 weeks)

  Baseline week4, week6 and 10 weeks

Study Arms (2)

Brain Chain Amino Acid (BCAA)

ACTIVE COMPARATOR

Subjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa, cross-over design

Dietary Supplement: BCAA

Placebo

PLACEBO COMPARATOR

Subjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa, cross-over design

Dietary Supplement: BCAA

Interventions

BCAA DIETARY_SUPPLEMENT

Subjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa

Also known as: Branch Chain Amino Acid

Brain Chain Amino Acid (BCAA); Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutriiton

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Woo SL, Yang J, Hsu M, Yang A, Zhang L, Lee RP, Gilbuena I, Thames G, Huang J, Rasmussen A, Carpenter CL, Henning SM, Heber D, Wang Y, Li Z. Effects of branched-chain amino acids on glucose metabolism in obese, prediabetic men and women: a randomized, crossover study. Am J Clin Nutr. 2019 Jun 1;109(6):1569-1577. doi: 10.1093/ajcn/nqz024.

  PMID: 31005973 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Obesity

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Placebo
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: BCAA

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 22, 2018
• Study Start: March 18, 2016
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2018
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)