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The Effects of Leucine and Isoleucine on Glucose Metabolism (AA+GLU)

Texas Woman's University logo

Texas Woman's University

Status

Completed

Conditions

Hyperglycemia

Treatments

Dietary Supplement: Leucine Supplement
Dietary Supplement: Isoleucine Supplement
Dietary Supplement: Leucine Supplement combined with Isoleucine Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT02634164
17757 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

12 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

12 participants in 4 patient groups

control
No Intervention group
Description:
Control Treatment with Oral Glucose Tolerance Test: Blood glucose and insulin will be obtained following the protocol of Eicher et al (4). Participants will ingest a Placebo (inert, calorie free, stevia sweetener) with blood collections at 0,2,4,6,8,10,30 prior to a standard 75 g glucose solution, followed by blood collections at 0,2,4,6,8,10,30,60,90,120 minutes post glucose ingestion. A total of 16 blood collections will be taken.
Leucine Supplement
Experimental group
Description:
Control Treatment with Oral Glucose Tolerance Test:
Treatment:
Dietary Supplement: Leucine Supplement
Isoleucine Supplement
Experimental group
Description:
Isoleucine Combined with Oral Glucose Tolerance Test:
Treatment:
Dietary Supplement: Isoleucine Supplement
Leucine and Isoleucine Supplement
Experimental group
Description:
Leucine and Isoleucine Combined with Oral Glucose Tolerance Test:
Treatment:
Dietary Supplement: Leucine Supplement combined with Isoleucine Supplement

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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