Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • IAA mix supplement

    Dietary 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.

  • Complementary food comprised of rice and legumes

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 2 interventions
Group B: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in the Gut Permeability as Assessed by the Lactulose/Rhamnose (L/R) Test at 28 days

Time frame
Baseline and end of intervention at 28 days

Secondary outcomes

1

Change from Baseline in Protein Absorption as Assessed by the Dual Stable Isotope Tracer (DSIT) Technique at 28 days

Time frame
Baseline and end of intervention at 28 days
2

Change from Baseline in Gut Digestive Capacity Measured by the 13C-Sucrose Breath Test (SBT) at 28 days

Time frame
Baseline and end of intervention at 28 days
3

Change from Baseline in Gut Function Based on Plasma LPS-Binding Protein (LPSBP) Concentration at 28 days

Time frame
Baseline and end of intervention at 28 days
4

Change from Baseline in Gut Function Based on Intestinal Fatty Acid Binding Protein (iFABP) Concentration at 28 days

Time frame
Baseline and end of intervention at 28 days

Other outcomes

1

Change from Baseline in Length-for-age z-score (LAZ) at 28 Days and 6 Months

Time frame
Baseline and end of intervention at 28 days and follow-up after 6 months
2

Change from Baseline in Weight at 28 days

Time frame
Baseline and end of intervention at 28 days
3

Change from Baseline in Body Composition in 6 months

Time frame
Baseline and follow-up after 6 months
4

Correlation Between Gut Microbiota Composition and Plasma Biomarkers of Gut Function (LPSBP and iFABP)

Time frame
Baseline, pre-intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: