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.
Up to thirty-two obese pre-pubertal children will be recruited for this study. Up to sixteen will be boys and up to sixteen will be girls. The study will be a double-blinded, placebo-controlled trial using a randomized, but counter-balanced design. This will ensure equal numbers in the two groups that the children are randomized to, for each sex. The control group will receive placebo and the intervention group will receive essential amino acids plus arginine. The supplements (essential amino acids plus arginine, and placebo) will be given in the form of a drink twice a day for a total of 8 weeks. Both the participants and the investigators will be blinded to group assignment. The primary endpoints of this study are to assess the effect of essential amino acids (EAA) plus arginine supplementation on lipid and protein metabolism. For this, liver lipid content, hepatic apoptosis, plasma lipids, apolipoprotein B-100 (apo B-100) levels, hepatic fatty oxidation, whole body insulin sensitivity, body composition and whole body protein turnover. will be compared between the intervention and placebo groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Flavored drink containing essential amino acids plus arginine.
Flavored drink without essential amino acids plus arginine.
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.
Time frame: 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.
Time frame: Baseline and 8 weeks
Whole body protein turnover before and after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.
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).
Time frame: 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.
Time frame: Baseline and 8 weeks
HOMA-IR index before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.
Fasting glucose and insulin levels will be used to assess changes in the HOMA-IR index after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.
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Time frame: Baseline and 8 weeks