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

Primary Purpose

Prediabetic State

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BCAA High Protein supplement

BCAA Low Protein supplement

About this trial

This is an interventional treatment trial for Prediabetic State focused on measuring pre-diabetes, blood glucose regulation, branching chain amino acids, diabetes, lower blood sugar

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

BCAA High Protein supplement

BCAA Low Protein Supplement

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

The major changes in glucose tolerance after taking supplement

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

The major changes in glucose tolerance after taking supplement

Secondary Outcome Measures

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

Change in body composition after taking supplement

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

Change in body composition after taking supplement

Full Information

NCT ID

NCT02684565

First Posted

February 9, 2016

Last Updated

February 8, 2018

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT02684565

Brief Title

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

Acronym

BCAA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetic State

Keywords

pre-diabetes, blood glucose regulation, branching chain amino acids, diabetes, lower blood sugar

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BCAA High Protein supplement

Arm Type

Active Comparator

Arm Description

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.

Arm Title

BCAA Low Protein Supplement

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

BCAA High Protein supplement

Other Intervention Name(s)

INNOBIO Instanized high BCAA Powder

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

BCAA Low Protein supplement

Other Intervention Name(s)

SunWarrior Warrior Blend Natural

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

The major changes in glucose tolerance after taking supplement

Time Frame

Baseline to 4 weeks

Title

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

Description

The major changes in glucose tolerance after taking supplement

Time Frame

Baseline to 4 weeks

Secondary Outcome Measure Information:

Title

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

Description

Change in body composition after taking supplement

Time Frame

baseline to 4 weeks

Title

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

Description

Change in body composition after taking supplement

Time Frame

Baseline to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoping Li, MD,PhD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25287287

Citation

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.

Results Reference

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PubMed Identifier

22961720

Citation

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.

Results Reference

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PubMed Identifier

20456814

Citation

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.

Results Reference

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

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