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
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.
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) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Arkansas Children's Hospital Research Institute |
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
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 |
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