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CompletedNCT03715010Updated Sep 20, 2019

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

An interventional study of BCAA in Pre-diabetes, Obese and Glucose Intolerance, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-20.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Mar 2016, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description
  1. BCAA's multiple functions in cells In addition to participating in de novo protein synthesis, Branched-Chain Amino Acids (BCAAs, including leucine, isoleucine, and valine) regulate multiple cellular functions as nutrient signaling. For example, BCAAs regulate insulin and glucagon secretion and thus glucose metabolism1. BCAAs, especially leucine, is one key regulator of mTOR signaling, which is the central component of a complex signaling network of insulin signaling, cell growth, and proliferation. BCAAs also regulate protein synthesis and degradation in various tissues.
  2. Impact of BCAA supplemental or BCAA-enriched diet on metabolism In addition to the healthcare utilization of BCAAs for liver disorders and their complications and other diseases, BCAA supplementation is common amongst athletes and fitness professionals to improve muscle building and strength. Meanwhile, BCAA supplementation or BCAA-rich protein diets are often associated with positive effects on body weight and glucose homeostasis1. Increasing dietary uptake of BCAAs improved the parameters associated with obesity and T2DM, such as body composition and glycemia levels. However, these beneficial effects are not conclusive. Moreover, other studies have shown that circulating branched-chain amino acid concentrations are associated with obesity and future insulin resistance in children and adolescents2.
  3. Summary Both beneficial and detrimental effects of BCAA on metabolism have been established and therefore warrants further investigation. In the preliminary study, we 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.
02

Conditions studied

  • Pre-diabetes
  • Obese
  • Glucose Intolerance
03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's enrollment of 14 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age 20-65 years of age at screen
  2. BMI between 27 to 40
  3. Fasting glucose level >100, but \<126 mg/dL or HgbA1c >5.7% but \< 6.4%
  4. Waist circumference > 40 in for men and >35 in for women
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
  3. Any subject who currently uses tobacco products.
  4. Any history of gastrointestinal disease except for appendectomy.
  5. Any antibiotic or laxative use during the 2 months before the study.
  6. Any subject who is unable or unwilling to comply with the study protocol.
  7. Any subject allergic to soy products.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
14 participants (actual)

Study arms

  • Active comparator
    Brain Chain Amino Acid (BCAA)

    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 comparator
    Placebo

    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

  • Dietary supplementBCAA

    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

06

What researchers measure

Primary outcomes

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

    To assess change of glucose AUC during 2H OGTT test

    Time frame: Baseline week4, week6 and 10 weeks

Secondary outcomes

  1. Measure of body composition (Time Frame: 10 weeks)

    To assess changes in body composition (fat mass, lean body mass in Kg)

    Time frame: Baseline week4, week6 and 10 weeks

07

Study locations

1 site
  • UCLA Center for Human Nutriiton
    Los Angeles, California 90095, United States
08

References and documents

Publications

  • 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. PubMed 31005973 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03715010
Lead sponsor
University of California, Los Angeles
Responsible party
Zhaoping Li (Professor of Medicine, University of California, Los Angeles) — Principal investigator
First posted
Oct 22, 2018
Start date
Mar 18, 2016
Primary completion
Jan 19, 2018
Completion
Jan 19, 2018
Last update
Sep 20, 2019

Study contacts

Zhaoping Li, MD, PhD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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