Clinical trial NCT02634164: The Effects of Leucine and Isoleucine on Glucose Metabolism
Official title: The Effects of Leucine and Isoleucine on Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: leucine
isoleucine
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Change in plasma glucose (0-150 minutes)
timeFrame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
measure: Change in plasma insulin (0-150 minutes)
timeFrame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
measure: Change in plasma GIP (0-150 minutes)
timeFrame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
measure: Change in plasma GLP-1 (0-150 minutes)
timeFrame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
Secondary outcomes:
measure: Change in plasma glucagon (0-150 minutes)
timeFrame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
measure: Change in plasma c-peptide (0-150 minutes)
timeFrame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
measure: Change in plasma L-Leucine (0-150 minutes)
timeFrame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
measure: Change in plasma L-Isoleucine (0-150 minutes)
timeFrame: baseline (0), 2, 4, 6, 8, 10, 30, 32, 34, 36, 38, 40, 60, 90, 120, 150 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Texas Woman's University Kinesiology Department
name: Vic Ben-Ezra, PhD
role: STUDY_CHAIR
References:
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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.
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.
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.
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.
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.