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

NCT ID: NCT02337894

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2023-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Essential amino acids plus arginine

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.

Group Type: EXPERIMENTAL

Essential amino acids plus arginine

Intervention Type: DIETARY_SUPPLEMENT

Flavored drink containing essential amino acids plus arginine.

Control drink

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Flavored drink without essential amino acids plus arginine.

Interventions

Essential amino acids plus arginine

Flavored drink containing essential amino acids plus arginine.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Flavored drink without essential amino acids plus arginine.

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva C Diaz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Elisabet Borsheim, Ph.D

Role: STUDY_DIRECTOR

University of Arkansas

References

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.

Reference Type: BACKGROUND

PMID: 19041223 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18294740 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19524336 (View on PubMed)

Other Identifiers

203454

Identifier Type: -

Identifier Source: org_study_id