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

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Leucine Supplement
Isoleucine Supplement
Leucine Supplement combined with Isoleucine Supplement
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperglycemia focused on measuring leucine, isoleucine

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts 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 -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    control

    Leucine Supplement

    Isoleucine Supplement

    Leucine and Isoleucine Supplement

    Arm 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.

    Control Treatment with Oral Glucose Tolerance Test:

    Isoleucine Combined with Oral Glucose Tolerance Test:

    Leucine and Isoleucine Combined with Oral Glucose Tolerance Test:

    Outcomes

    Primary Outcome Measures

    Change in plasma glucose (0-150 minutes)
    Blood collections
    Change in plasma insulin (0-150 minutes)
    Blood collections
    Change in plasma GIP (0-150 minutes)
    Blood Collections
    Change in plasma GLP-1 (0-150 minutes)
    Blood collections

    Secondary Outcome Measures

    Change in plasma glucagon (0-150 minutes)
    Blood collections
    Change in plasma c-peptide (0-150 minutes)
    Blood Collections
    Change in plasma L-Leucine (0-150 minutes)
    Blood Collections
    Change in plasma L-Isoleucine (0-150 minutes)
    Blood Collections

    Full Information

    First Posted
    December 9, 2015
    Last Updated
    April 25, 2017
    Sponsor
    Texas Woman's University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02634164
    Brief Title
    The Effects of Leucine and Isoleucine on Glucose Metabolism
    Acronym
    AA+GLU
    Official Title
    The Effects of Leucine and Isoleucine on Glucose Metabolism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Texas Woman's University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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: 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 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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperglycemia
    Keywords
    leucine, isoleucine

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Leucine Supplement
    Arm Type
    Experimental
    Arm Description
    Control Treatment with Oral Glucose Tolerance Test:
    Arm Title
    Isoleucine Supplement
    Arm Type
    Experimental
    Arm Description
    Isoleucine Combined with Oral Glucose Tolerance Test:
    Arm Title
    Leucine and Isoleucine Supplement
    Arm Type
    Experimental
    Arm Description
    Leucine and Isoleucine Combined with Oral Glucose Tolerance Test:
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Leucine Supplement
    Intervention Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Isoleucine Supplement
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Leucine Supplement combined with Isoleucine Supplement
    Intervention Description
    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 Outcome Measure Information:
    Title
    Change in plasma glucose (0-150 minutes)
    Description
    Blood collections
    Time Frame
    baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
    Title
    Change in plasma insulin (0-150 minutes)
    Description
    Blood collections
    Time Frame
    baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
    Title
    Change in plasma GIP (0-150 minutes)
    Description
    Blood Collections
    Time Frame
    baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
    Title
    Change in plasma GLP-1 (0-150 minutes)
    Description
    Blood collections
    Time Frame
    baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
    Secondary Outcome Measure Information:
    Title
    Change in plasma glucagon (0-150 minutes)
    Description
    Blood collections
    Time Frame
    baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
    Title
    Change in plasma c-peptide (0-150 minutes)
    Description
    Blood Collections
    Time Frame
    baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
    Title
    Change in plasma L-Leucine (0-150 minutes)
    Description
    Blood Collections
    Time Frame
    baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
    Title
    Change in plasma L-Isoleucine (0-150 minutes)
    Description
    Blood Collections
    Time Frame
    baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vic Ben-Ezra, PhD
    Organizational Affiliation
    Texas Woman's University Kinesiology Department
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22293293
    Citation
    Yoshizawa F. New therapeutic strategy for amino acid medicine: notable functions of branched chain amino acids as biological regulators. J Pharmacol Sci. 2012;118(2):149-55. doi: 10.1254/jphs.11r05fm. Epub 2012 Jan 27.
    Results Reference
    background
    PubMed Identifier
    16941278
    Citation
    Nuttall FQ, Schweim KJ, Gannon MC. Effect of orally administered phenylalanine with and without glucose on insulin, glucagon and glucose concentrations. Horm Metab Res. 2006 Aug;38(8):518-23. doi: 10.1055/s-2006-949523.
    Results Reference
    result
    PubMed Identifier
    20882645
    Citation
    Gannon MC, Nuttall FQ. Amino acid ingestion and glucose metabolism--a review. IUBMB Life. 2010 Sep;62(9):660-8. doi: 10.1002/iub.375.
    Results Reference
    result
    PubMed Identifier
    19013300
    Citation
    Kalogeropoulou D, Lafave L, Schweim K, Gannon MC, Nuttall FQ. Leucine, when ingested with glucose, synergistically stimulates insulin secretion and lowers blood glucose. Metabolism. 2008 Dec;57(12):1747-52. doi: 10.1016/j.metabol.2008.09.001.
    Results Reference
    result
    PubMed Identifier
    17413098
    Citation
    Nilsson M, Holst JJ, Bjorck IM. Metabolic effects of amino acid mixtures and whey protein in healthy subjects: studies using glucose-equivalent drinks. Am J Clin Nutr. 2007 Apr;85(4):996-1004. doi: 10.1093/ajcn/85.4.996.
    Results Reference
    result
    PubMed Identifier
    19835582
    Citation
    Petersen BL, Ward LS, Bastian ED, Jenkins AL, Campbell J, Vuksan V. A whey protein supplement decreases post-prandial glycemia. Nutr J. 2009 Oct 16;8:47. doi: 10.1186/1475-2891-8-47.
    Results Reference
    result
    PubMed Identifier
    14651987
    Citation
    Doi M, Yamaoka I, Fukunaga T, Nakayama M. Isoleucine, a potent plasma glucose-lowering amino acid, stimulates glucose uptake in C2C12 myotubes. Biochem Biophys Res Commun. 2003 Dec 26;312(4):1111-7. doi: 10.1016/j.bbrc.2003.11.039.
    Results Reference
    result
    PubMed Identifier
    15591158
    Citation
    Nishitani S, Takehana K, Fujitani S, Sonaka I. Branched-chain amino acids improve glucose metabolism in rats with liver cirrhosis. Am J Physiol Gastrointest Liver Physiol. 2005 Jun;288(6):G1292-300. doi: 10.1152/ajpgi.00510.2003. Epub 2004 Dec 9.
    Results Reference
    result

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    The Effects of Leucine and Isoleucine on Glucose Metabolism

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