WithdrawnNot Applicable

Effects of Amino Acid Supplementation on Liver Lipid Content and Protein Metabolism in Obese Children

Stopped: Study not funded

0Started 2022-01-30

Plain-language 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.

Who can participate

Age range7 Years – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Liver lipid content before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.

Timeframe: Baseline and 8 weeks

Whole body protein turnover before and after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.

Timeframe: Baseline and 8 weeks

Body composition before and after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.

Timeframe: Baseline and 8 weeks

Trial details

NCT IDNCT02337894

SponsorArkansas Children's Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02

View on ClinicalTrials.gov More Liver Steatosis trials

Plain-language summary

Who can participate

Age range7 Years – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Liver lipid content before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.

Timeframe: Baseline and 8 weeks

Whole body protein turnover before and after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.

Timeframe: Baseline and 8 weeks

Body composition before and after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.

Timeframe: Baseline and 8 weeks