The Effects of Leucine and Isoleucine on Glucose Metabolism

Not Applicable

Completed

• Conditions: Hyperglycemia
• Interventions: Dietary Supplement: Leucine Supplement combined with Isoleucine Supplement; Dietary Supplement: Isoleucine Supplement; Dietary Supplement: Leucine Supplement

• Registration Number: NCT02634164
• Lead Sponsor: Texas Woman's University

Brief Summary

Diabetes is classified as an impairment of the body's ability to control blood glucose levels. Uncontrolled hyperglycemia can give rise to macrovascular (i.e., heart disease and stroke) and microvasculature damage such as retinopathy, nephropathy and neuropathy. These comorbidities may definitively reduce quality of life.

Hypotheses to be tested:

1. The ingestion of amino acids L-Isoleucine and L-Leucine at a therapeutic dose prior to a glucose load will concurrently and independently improve glucose tolerance.

2. The ingestion of L-Isoleucine and L-Leucine separately or together will have a minimal effect on incretin responses of Glucagon-like peptide-1 and Glucose-dependent insulinotropic peptide (GLP-1, GIP).

Detailed Description

Specific Aims and Hypothesis Diabetes is classified as an impairment of the body's ability to control blood glucose levels. Uncontrolled hyperglycemia can give rise to macrovascular (i.e., heart disease and stroke) and microvasculature damage such as retinopathy, nephropathy and neuropathy. These comorbidities may definitively reduce quality of life.

Hypotheses to be tested:

1. The ingestion of amino acids L-Isoleucine and L-Leucine at a therapeutic dose prior to a glucose load will concurrently and independently improve glucose tolerance.

2. The ingestion of L-Isoleucine and L-Leucine separately or together will have a minimal effect on incretin responses (GLP-1, GIP).

Specific Aims:

1. Specific Aim I will test the hypothesis that the ingestion of amino acids L-Isoleucine and L-Leucine at a therapeutic dose prior to a glucose load will concurrently and independently improve glucose tolerance.

2. Specific Aim II will test the hypothesis that the ingestion of L-Isoleucine and L-Leucine will have a minimal effect on incretin responses in conjunction with prior research.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-17
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. age range of 20 to 40 years of age
2. (sedentary lifestyle) Participants whom exercise less than the American College of Sports Medicine recommendation of weekly physical activity levels or are completely sedentary may be admitted into the study
3. Apparently healthy
4. Currently not using supplemental branch chain amino acids (BCAA) or whey protein
5. Non-smoking

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Exclusion Criteria

1. Chronic or acute health problems
2. Smoker
3. Currently using supplemental BCAA or whey protein -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leucine and Isoleucine Supplement	Leucine Supplement combined with Isoleucine Supplement	Leucine and Isoleucine Combined with Oral Glucose Tolerance Test:
Isoleucine Supplement	Isoleucine Supplement	Isoleucine Combined with Oral Glucose Tolerance Test:
Leucine Supplement	Leucine Supplement	Control Treatment with Oral Glucose Tolerance Test:

Primary Outcome Measures

Name	Time	Method
Change in plasma GIP (0-150 minutes)	baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes	Blood Collections
Change in plasma glucose (0-150 minutes)	baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes	Blood collections
Change in plasma GLP-1 (0-150 minutes)	baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes	Blood collections
Change in plasma insulin (0-150 minutes)	baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes	Blood collections

Secondary Outcome Measures

Name	Time	Method
Change in plasma L-Leucine (0-150 minutes)	baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes	Blood Collections
Change in plasma glucagon (0-150 minutes)	baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes	Blood collections
Change in plasma c-peptide (0-150 minutes)	baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes	Blood Collections
Change in plasma L-Isoleucine (0-150 minutes)	baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes	Blood Collections