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

NCT02337894 | Withdrawn DMC

• 1 other identifier: 203454
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Steatosis; Insulin Resistance; Whole Body Protein Metabolism; Body Composition, Beneficial

Keywords

Protein kinetics; liver steatosis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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.

  Baseline and 8 weeks

Secondary Outcomes (1)

• HOMA-IR index before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.

  Baseline and 8 weeks

Study Arms (2)

Essential amino acids plus arginine

EXPERIMENTAL

Children randomized to the intervention group will receive a supplement containing essential amino acids plus arginine in the form of a drink which they will have to take for 8 weeks. Measurement of liver lipid content, hepatic apoptosis, plasma lipids, apolipoprotein B-100 levels, hepatic fatty oxidation, whole body insulin sensitivity, body composition and whole body protein turnover will be compared with the the placebo group, and before and after the intervention.

Dietary Supplement: Essential amino acids plus arginine

Control drink

PLACEBO COMPARATOR

The control drinks will be indistinguishable from the intervention drinks in taste and volume, but will contain placebo rather than essential amino acids plus arginine.

Dietary Supplement: Placebo

Interventions

Essential amino acids plus arginine DIETARY_SUPPLEMENT

Flavored drink containing essential amino acids plus arginine.

Essential amino acids plus arginine

Placebo DIETARY_SUPPLEMENT

Flavored drink without essential amino acids plus arginine.

Control drink

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Related Publications (3)

• 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.

  PMID: 19041223 BACKGROUND

• 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.

  PMID: 18294740 BACKGROUND

• 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.

  PMID: 19524336 BACKGROUND

MeSH Terms

Conditions

Fatty Liver; Insulin Resistance; Glucocorticoid Receptor Deficiency

Interventions

Amino Acids, Essential; Arginine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Basic; Amino Acids, Diamino

Study Officials

• Eva C Diaz, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

• Elisabet Borsheim, Ph.D

  University of Arkansas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: January 14, 2015
• Study Start: January 30, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: October 2, 2025

Record last verified: 2025-09