Amino Acid Supplementation in Children with Stunting
ConditionStunted Growth
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-36
SponsorFood and Nutrition Research Institute, Philippines
About this trial
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.
Eligibility criteria
Qualifiers
18 to 36 months old (of either sex)
Stunted (LAZ of less than -2)
Parent, caregiver or guardian able and willing to give written, informed consent
Disqualifiers
Wasted (WHZ of less than -2)
Overweight (WHZ of more than 2)
Have had diarrhea (by self-report) in the preceding month
Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
Trial design
Treatments tested in this trial
- IAA mix supplement
- Complementary food comprised of rice and legumes
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Food and Nutrition Research Institute, Philippines
Lead sponsor
International Atomic Energy Agency
Collaborator
University of Glasgow
Collaborator
Ghana Atomic Energy Commission
Collaborator
Kamuzu University of Health Sciences
Collaborator
University of Zambia
Collaborator
Rutgers, The State University of New Jersey
Collaborator
St. John's Research Institute
Collaborator
cnesten, Morocco
Collaborator
Source ClinicalTrials.gov