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 range

7 Years – 10 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

7 Years – 10 Years

Sex

ALL

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