Study not funded
Effects of Nutritional Supplementation With Amino Acids on Liver Lipid Content, Whole-body Protein Turnover, and Body Composition in Obese Pre-pubertal Children
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
January 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to assess the effect of an eight-week dietary supplementation with essential amino acids plus arginine on liver and plasma lipid content, whole-body fat oxidation, whole-body insulin sensitivity, whole body protein metabolism, and body composition in obese pre-pubertal children.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2014
Actual (reported)January 14, 2015
Actual (reported)January 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Serum levels of markers of lipid metabolism before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.
Change in serum levels of triglycerides, cholesterol, very low density lipoprotein (VLDL), low density lipoprotein (LDL), beta-hydroxybutyrate, Apo-lipoprotein B and plasma cytokeratin 18 will be assessed after 8 weeks of essential amino acids plus arginine vs placebo.
Baseline and 8 weeks
Liver lipid content before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.
Nuclear Magnetic Resonance Spectroscopy will be used to assess changes in liver lipid content following an 8-week supplementation period with essential amino acids plus arginine vs. placebo.
Baseline and 8 weeks
Whole body protein turnover before and after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.
Children randomized to the intervention group will receive a supplement containing essential amino acids plus arginine in the form of a drink which they will have to take for 8 weeks. Measurement of liver lipid content, hepatic apoptosis, plasma lipids, apolipoprotein B-100 levels, hepatic fatty oxidation, whole body insulin sensitivity, body composition and whole body protein turnover will be compared with the the placebo group, and before and after the intervention.
The control drinks will be indistinguishable from the intervention drinks in taste and volume, but will contain placebo rather than essential amino acids plus arginine.
Flavored drink containing essential amino acids plus arginine.
Flavored drink without essential amino acids plus arginine.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Borsheim E, Bui QU, Tissier S, Cree MG, Ronsen O, Morio B, Ferrando AA, Kobayashi H, Newcomer BR, Wolfe RR. Amino acid supplementation decreases plasma and liver triacylglycerols in elderly. Nutrition. 2009 Mar;25(3):281-8. doi: 10.1016/j.nut.2008.09.001. Epub 2008 Nov 28.
Borsheim E, Bui QU, Tissier S, Kobayashi H, Ferrando AA, Wolfe RR. Effect of amino acid supplementation on muscle mass, strength and physical function in elderly. Clin Nutr. 2008 Apr;27(2):189-95. doi: 10.1016/j.clnu.2008.01.001. Epub 2008 Mar 4.
Eva C Diaz, MD
University of Arkansas
Elisabet Borsheim, Ph.D
University of Arkansas
0 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2014
First Posted
January 14, 2015
Study Start
January 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mechanisms of Insulin Resistance and Exercise in South Asians
Change in whole body protein metabolism (synthesis and breakdown) following 8 weeks of essential amino acids plus arginine vs placebo. This outcome will be assessed using a stable isotope of an amino acid (15N-alanine).
Baseline and 8 weeks
Body composition before and after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.
Changes in body composition (fat free mass and fat mass) will be assessed using Dual-Energy X-ray Absorptiometry. Measurements will be carried out at baseline and following 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.
Baseline and 8 weeks
HOMA-IR index before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.
Baseline and 8 weeks
Contact the study team to confirm eligibility.
van Vught AJ, Heitmann BL, Nieuwenhuizen AG, Veldhorst MA, Brummer RJ, Westerterp-Plantenga MS. Association between dietary protein and change in body composition among children (EYHS). Clin Nutr. 2009 Dec;28(6):684-8. doi: 10.1016/j.clnu.2009.05.001. Epub 2009 Jun 12.
Primary Completion
February 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 2, 2025
Record last verified: 2025-09
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Source: ClinicalTrials.gov.
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