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

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02337894
• Other study ID #: 203454
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: February 2023

Study information

• Verified date: January 2021
• Source: Arkansas Children's Hospital Research Institute
• Contact: Eva C Diaz, MD
• Phone: 501-364-3056
• Email: ecdiazfuentes[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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)

Related Conditions & MeSH terms

• Body Composition, Beneficial
• Fatty Liver
• Insulin Resistance
• Liver Steatosis
• Whole Body Protein Metabolism

Intervention

Dietary Supplement:
• Essential amino acids plus arginine
Flavored drink containing essential amino acids plus arginine.
• Placebo
Flavored drink without essential amino acids plus arginine.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

References & Publications (3)

Børsheim E, Bui QU, Tissier S, Cree MG, Rønsen 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. — View Citation

Børsheim 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	HOMA-IR index before and after 8 weeks of supplementation with essential amino acids plus arginine vs placebo.	Fasting glucose and insulin levels will be used to assess changes in the HOMA-IR index after 8 weeks of supplementation with essential amino acids plus arginine vs. placebo.	Baseline and 8 weeks