Clinical Trial

Amino Acid Supplementation in Children with Stunting

Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated November 6, 2024 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this intervention study is to determine the effects of indispensable amino acid (IAA) supplementation on children of either sex, aged 18 to 36 months. The main questions it aims to answer are: * Does IAA supplementation affect biomarkers of Environmental Enteric Dysfunction (EED), through the Dual Sugar Lactulose/Rhamnose (L/R) test, plasma intestinal fatty acid binding protein, plasma lipopolysaccharide binding protein, fecal myeloperoxidase, fecal neopterin, and gut microbiota? * Does IAA supplementation impact amino acid digestion, as assessed by a dual-stable isotope tracer? * What is the weight gain and the changes in length-for-Age z-scores (LAZ) and body composition? The researchers will compare the effects of consumption of standard complementary food with added IAA against a control group that has no added IAA through the assessment of the various biomarkers. Participants will: * answer questions regarding personal, demographic, anthropometric, and food intake information. * provide biological samples, including breath, urine, stool, blood, and saliva. * consume solutions or meals that contain sugars and/or stable isotope tracers. * visit the FNRI and receive house visits by study staff. * consume complementary food with or without supplement daily for 28 days.
Trial Details
NCT Number NCT06676215
Lead Sponsor Food and Nutrition Research Institute, Philippines
Collaborators: International Atomic Energy Agency, University of Glasgow, Ghana Atomic Energy Commission, Kamuzu University of Health Sciences, University of Zambia, Rutgers, The State University of New Jersey, St. John's Research Institute, cnesten, Morocco
Conditions Stunted Growth
Enrollment 60 participants
Start Date 2025-02-01
Primary Completion 2025-09 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-11-06