Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06676215
NA

Amino Acid Supplementation in Children with Stunting

Sponsor: Food and Nutrition Research Institute, Philippines

View on ClinicalTrials.gov

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.

Official title: Efficacy of Amino Acid Supplementation on Gut Function and Nutritional Status in FIlipino Children Below Three Years Old

Key Details

Gender

All

Age Range

18 Months - 36 Months

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-02-01

Completion Date

2025-12

Last Updated

2024-11-06

Healthy Volunteers

No

Conditions

Interventions

DIETARY_SUPPLEMENT

IAA mix supplement

The intervention is a daily IAA dose that provides x1.5 the estimated average requirement (EAR) for a healthy child. This IAA dose will be mixed to the complementary food and will be taken once daily for 4 weeks (28 days) by the child in the intervention group.

OTHER

Complementary food comprised of rice and legumes

Each study child will receive standard complementary food which he/she will take once daily for 4 weeks (28 days)

Locations (1)

Department of Science and Technology - Food and Nutrition Research Institute

City of Taguig, National Capital Region, Philippines