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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02684565
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Zhaoping Li, University of California, Los Angeles

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.


Condition or disease Intervention/treatment Phase
Prediabetic State Dietary Supplement: BCAA High Protein supplement Dietary Supplement: BCAA Low Protein supplement Not Applicable

Detailed Description:

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.

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 adolescents.

This is a 12-week, randomized, crossover study with 10 obese subjects with prediabetes. Subjects will be randomly assigned to take 20g 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.

At baseline and weeks 4, 6 and 10 weeks glucose, insulin and triglyceride levels will be tested at time 0, 30 min, 60 min, and 120 min after 75 grams of glucose load. In addition to laboratory tests vital signs, weight and body composition will be done.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Branch Chain Amino Acids on Glucose Tolerance in Obese Pre-Diabetic Subjects
Actual Study Start Date : October 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BCAA High Protein supplement
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
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.
Other Name: INNOBIO Instanized high BCAA Powder

Active Comparator: BCAA Low Protein Supplement
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
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.
Other Name: SunWarrior Warrior Blend Natural




Primary Outcome Measures :
  1. Change in glucose tolerance composition that Are Related to High protein BCAA Treatment [ Time Frame: Baseline to 4 weeks ]
    The major changes in glucose tolerance after taking supplement

  2. Change in glucose tolerance and body composition that Are Related to Low protein BCAA Treatment [ Time Frame: Baseline to 4 weeks ]
    The major changes in glucose tolerance after taking supplement


Secondary Outcome Measures :
  1. Change in glucose tolerance and body composition that Are Related to Low protein BCAA treament [ Time Frame: baseline to 4 weeks ]
    Change in body composition after taking supplement

  2. Change in glucose tolerance and body composition that Are Related to High Protein BCAA treament [ Time Frame: Baseline to 4 weeks ]
    Change in body composition after taking supplement



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684565


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Zhaoping Li, MD,PhD University of California, Los Angeles

Publications:
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Responsible Party: Zhaoping Li, Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02684565    
Other Study ID Numbers: IRB#15-001928
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zhaoping Li, University of California, Los Angeles:
pre-diabetes
blood glucose regulation
branching chain amino acids
diabetes
lower blood sugar
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases