Amino Acid Supplementation in Children with Stunting

November 4, 2024 updated by: Amster Fei Baquiran, Food and Nutrition Research Institute, Philippines

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Protocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive the standard complementary foods (in the control group) or standard complementary foods supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) (in the intervention group).

Standard complementary foods will be comprised of ingredients mainly of rice and legumes. Standard complementary foods are foods that meet the dietary needs of children 6-36 months of age.

At least three observed (controlled) feeding sessions per week will be conducted over the 4 weeks of the study to confirm that the entire supplement was consumed or confirm intake. The observed feeding will take place at the child's home or at the barangay center. Uptake on non-observed days will be based on the caregiver's report. On each intervention monitoring day, a questionnaire will also be administered to assess child morbidity that day and on the day prior. A pediatrician or an alternate medical practitioner will also be invited during the data collection where in stable isotopes will be administered. The duties and responsibilities of the physician include: medical assessment of the participant, assistance in the collection of blood samples, assessment of adverse events (if any), and provision of first aid (if needed).

In the absence of treatment delays due to adverse events, the intervention will continue for 1 month or until one of the following criteria apply:

  • Child is not able to tolerate the supplement (throws up)
  • Severe acute malnutrition (SAM)
  • Inter-current illness that prevents further administration of treatment
  • Unacceptable adverse event(s)
  • Study participant voluntarily withdraws from treatment OR
  • Other general or specific changes in the study participant's condition render the study participant unacceptable for further treatment in the judgment of the investigator.

For each participant, tests to be conducted at study enrolment will be spread over three days. At the end of the study, endline tests will be spread over 2 days. Baseline visits for breath, blood, urine, and fecal collection should be conducted within -3 days prior to study treatment (day 3) while endline visits should be conducted within +7 days of study treatment (day 31). The intervention will be provided in coded sachets, distributed as per convenient for local custom to best ensure compliance with a minimum of three supervised feeds per week to ensure supplement is consumed at least periodically by the child and also to assess compliance.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Amster Fei P. Baquiran, BS Chemistry
  • Phone Number: 341 +632 8837 8113
  • Email: afpbaquiran@gmail.com

Study Contact Backup

  • Name: Carl Vincent D. Cabanilla, BS Chemistry
  • Phone Number: 307 +632 8837 8113
  • Email: cvdcabanilla@gmail.com

Study Locations

  • Philippines
    • Metro Manila
      • Taguig, Metro Manila, Philippines, 1631
        • Department of Science and Technology - Food and Nutrition Research Institute
        • Contact:
        • Contact:
          • Amster Fei P. Baquiran, BS Chemistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Have taken antibiotics in the preceding month
  • Have food allergies/intolerance
  • Had a serious illness within the last three (3) months or have any underlying condition which in the opinion of the pediatrician would put the subject at undue risk of failing study completion or would interfere with analysis of study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
complementary food supplemented with indispensable amino acid (IAA) mix
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)
Experimental: Control Group
complementary food without IAA mix
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and end of intervention at 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and end of intervention at 28 days
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
Baseline and end of intervention at 28 days
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
Baseline and end of intervention at 28 days
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
Baseline and end of intervention at 28 days
Change from Baseline in Gut Inflammation Based on Fecal Myeloperoxidase Concentration at 28 days
Time Frame: Baseline and end of intervention at 28 days
Baseline and end of intervention at 28 days
Change from Baseline in Gut Inflammation Based on Fecal Neopterin Concentration at 28 days
Time Frame: Baseline and end of intervention at 28 days
Baseline and end of intervention at 28 days

Other Outcome Measures

Outcome Measure
Time Frame
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
Baseline and end of intervention at 28 days and follow-up after 6 months
Change from Baseline in Weight at 28 days
Time Frame: Baseline and end of intervention at 28 days
Baseline and end of intervention at 28 days
Change from Baseline in Body Composition in 6 months
Time Frame: Baseline and follow-up after 6 months
Baseline and follow-up after 6 months
Correlation Between Gut Microbiota Composition and Plasma Biomarkers of Gut Function (LPSBP and iFABP)
Time Frame: Baseline, pre-intervention
Baseline, pre-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Food and Nutrition Research Institute, Philippines

Collaborators

International Atomic Energy Agency
Kamuzu University of Health Sciences
Rutgers, The State University of New Jersey
University of Glasgow
University of Zambia
St. John's Research Institute
Ghana Atomic Energy Commission
cnesten, Morocco

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIERC-2023-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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