Effects of Amino Acid Supplementation on Liver Lipid Content and Protein Metabolism in Obese Children
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Body Composition, Beneficial
- Insulin Resistance
- Liver Steatosis
- Whole Body Protein Metabolism
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Other
Participation Requirements
- Age
- Between 7 years and 10 years
- Gender
- Both males and females
Description
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 th...
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.
Tracking Information
- NCT #
- NCT02337894
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Eva C Diaz, MD University of Arkansas Study Director: Elisabet Borsheim, Ph.D University of Arkansas