Clinical trial NCT02337894: Effects of Amino Acid Supplementation on Liver Lipid Content and Protein Metabolism in Obese Children
Official title: Effects of Nutritional Supplementation With Amino Acids on Liver Lipid Content, Whole-body Protein Turnover, and Body Composition in Obese Pre-pubertal Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Steatosis
Insulin Resistance
Whole Body Protein Metabolism
Body Composition, Beneficial
Keywords: Protein kinetics
liver steatosis
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Healthy boy or girl
* Age 7-10 years of age and Tanner stage no greater than stage 1
* BMI ≥ 95th percentile
* Not participating for more than 1 hour/week in a regular physical activity program

Exclusion Criteria:

* Tanner stage greater than stage 1
* Having known chronic illnesses/disorders that may independently affect study outcome measures: type 2 or type 1 diabetes mellitus, neurologic (e.g. epilepsy), neurobehavioral (e.g. Attention deficit disorder and hyperactivity, ADHD) endocrine, hepatic, autoimmune, cardiac and renal disorders. Also, chronic lung disorders except well controlled asthma that does not require permanent use of inhaled/oral steroids
* Taking permanent medications: thyroid hormone replacement therapy, inhaled/oral steroids, insulin, metformin, anabolic drugs (growth hormone replacement therapy and oxandrolone) anti-lipid medication, blood pressure medication, ADHD medication (methylphenidate, amphetamines, atomoxetine)

Primary outcomes:
measure: Serum levels of markers of lipid metabolism before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.
timeFrame: Baseline and 8 weeks
measure: Liver lipid content before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.
timeFrame: Baseline and 8 weeks
measure: Whole body protein turnover before and after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.
timeFrame: Baseline and 8 weeks
measure: Body composition before and after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: HOMA-IR index before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Arkansas
name: Eva C Diaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Elisabet Borsheim, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.