NCT02684565

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

February 9, 2016

Last Update Submit

February 8, 2018

Conditions

Prediabetic State

Keywords

pre-diabetesblood glucose regulationbranching chain amino acidsdiabeteslower blood sugar

Outcome Measures

Primary Outcomes (2)

  • Change in glucose tolerance composition that Are Related to High protein BCAA Treatment

    The major changes in glucose tolerance after taking supplement

    Baseline to 4 weeks

  • Change in glucose tolerance and body composition that Are Related to Low protein BCAA Treatment

    The major changes in glucose tolerance after taking supplement

    Baseline to 4 weeks

Secondary Outcomes (2)

  • Change in glucose tolerance and body composition that Are Related to Low protein BCAA treament

    baseline to 4 weeks

  • Change in glucose tolerance and body composition that Are Related to High Protein BCAA treament

    Baseline to 4 weeks

Study Arms (2)

BCAA High Protein supplement

ACTIVE COMPARATOR

Subjects will be randomly assigned to take high BCAA protein a day for 4 weeks after a 2-week washout will switch to the other arm.

Dietary Supplement: BCAA High Protein supplement

BCAA Low Protein Supplement

ACTIVE COMPARATOR

Subjects will be randomly assigned to take low BCAA protein a day for 4 weeks after a 2-week washout will switch to the other arm.

Dietary Supplement: BCAA Low Protein supplement

Interventions

BCAA High Protein supplementDIETARY_SUPPLEMENT

Subjects will be randomly assigned to take high BCAA or low-BCAA protein a day for 4 weeks, then switch to BCAA or low-BCAA protein for 4 weeks after a 2-week washout.

Also known as: INNOBIO Instanized high BCAA Powder
BCAA High Protein supplement
BCAA Low Protein supplementDIETARY_SUPPLEMENT

Subjects will be randomly assigned to take high BCAA or low-BCAA protein a day for 4 weeks, then switch to BCAA or low-BCAA protein for 4 weeks after a 2-week washout.

Also known as: SunWarrior Warrior Blend Natural
BCAA Low Protein Supplement

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (3)

  • Lynch CJ, Adams SH. Branched-chain amino acids in metabolic signalling and insulin resistance. Nat Rev Endocrinol. 2014 Dec;10(12):723-36. doi: 10.1038/nrendo.2014.171. Epub 2014 Oct 7.

    PMID: 25287287BACKGROUND

  • McCormack SE, Shaham O, McCarthy MA, Deik AA, Wang TJ, Gerszten RE, Clish CB, Mootha VK, Grinspoon SK, Fleischman A. Circulating branched-chain amino acid concentrations are associated with obesity and future insulin resistance in children and adolescents. Pediatr Obes. 2013 Feb;8(1):52-61. doi: 10.1111/j.2047-6310.2012.00087.x. Epub 2012 Sep 7.

    PMID: 22961720BACKGROUND

  • Pal S, Ellis V. The acute effects of four protein meals on insulin, glucose, appetite and energy intake in lean men. Br J Nutr. 2010 Oct;104(8):1241-8. doi: 10.1017/S0007114510001911. Epub 2010 May 11.

    PMID: 20456814BACKGROUND

MeSH Terms

Conditions

Prediabetic StateGlucose IntoleranceDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Zhaoping Li, MD,PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 18, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 12, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)