Amino Acid Supplementation in Children with Stunting

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.

Conditions

• Stunted Growth

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)

Sponsors & Collaborators

• International Atomic Energy Agency

  collaborator OTHER_GOV

• University of Glasgow

  collaborator OTHER

• Ghana Atomic Energy Commission

  collaborator UNKNOWN

• Kamuzu University of Health Sciences

  collaborator OTHER

• University of Zambia

  collaborator OTHER

• Rutgers, The State University of New Jersey

  collaborator OTHER

• St. John's Research Institute

  collaborator OTHER

• cnesten, Morocco

  collaborator UNKNOWN

• Food and Nutrition Research Institute, Philippines

  lead OTHER_GOV

Principal Investigators

• Amster Fei P. Baquiran, BS Chemistry · Department of Science and Technology Food and Nutrition Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2025-09-30

Completion

2025-12-31

Countries

• Philippines

Study Locations