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OpenTrials
Completed

NCT Number: NCT02634164

The Effects of Leucine and Isoleucine on Glucose Metabolism

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).

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Key information

Conditions

Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

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

Specific Aims:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age range of 20 to 40 years of age
  • (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
  • Apparently healthy
  • Currently not using supplemental branch chain amino acids (BCAA) or whey protein
  • Non-smoking

Exclusion criteria

  • Chronic or acute health problems
  • Smoker
  • Currently using supplemental BCAA or whey protein -

Treatment and study plan

Leucine Supplement

Dietary Supplement

For this visit participants will ingest a powdered form of Leucine in the amount of 0.3g/kg of lean body mass weight with water (150 mL) with additional water if needed to ensure dose is fully consumed. The amino acid solution will be ingested 30 min prior to 75 g glucose solution

Isoleucine Supplement

Dietary Supplement

For this visit participants will ingest a powdered form of Isoleucine in the amount of 0.3g/kg of lean body mass weight with water (150 mL) with additional water if needed to ensure dose is fully consumed. The amino acid solution will be ingested 30 min prior to 75 g glucose solution.

Leucine Supplement combined with Isoleucine Supplement

Dietary Supplement

For this visit participants will ingest a powdered form of Leucine and Isoleucine in the amount of 0.3g/kg of lean body mass weight (equal in total dosage to other treatments) with water (150 mL) with additional water if needed to ensure dose is fully consumed. The amino acid solution will be ingested 30 min prior to 75 g glucose solution.

Primary outcomes

  1. Change in plasma glucose (0-150 minutes)

    Time frame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes

    Blood collections

  2. Change in plasma insulin (0-150 minutes)

    Time frame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes

    Blood collections

  3. Change in plasma GIP (0-150 minutes)

    Time frame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes

    Blood Collections

  4. Change in plasma GLP-1 (0-150 minutes)

    Time frame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes

    Blood collections

Secondary outcomes

  1. Change in plasma glucagon (0-150 minutes)

    Time frame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes

    Blood collections

  2. Change in plasma c-peptide (0-150 minutes)

    Time frame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes

    Blood Collections

  3. Change in plasma L-Leucine (0-150 minutes)

    Time frame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes

    Blood Collections

  4. Change in plasma L-Isoleucine (0-150 minutes)

    Time frame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes

    Blood Collections

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Acronym: AA+GLU

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2015
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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