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Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala

NCT07804667 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-09-04

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala. The study will also explore whether the food is associated with short-term changes in stool markers related to gut inflammation and microbial activity.

The main questions are:

* Will children accept and regularly eat the modified food supplement?
* What stomach or bowel symptoms, if any, occur while children eat the supplement?
* Do stool markers related to gut health change over the short study period?

Researchers will compare the modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement already used in Guatemala. Children will be assigned by chance to one of the two groups.

Participants will:

* Complete a brief taste and acceptability test
* Eat one 30-gram sachet of the assigned food each day for 21 days
* Have their caregiver receive brief phone or WhatsApp check-ins during the study
* Provide a stool sample near the beginning and end of the study

This is a small pilot study. It is designed to assess feasibility, acceptability, tolerability, and early biological signals rather than to determine whether the modified food improves growth or other clinical outcomes.

Conditions

  • Stunting of Growth
  • Chronic Malnutrition

Interventions

DIETARY_SUPPLEMENT

Modified Therapeutic Food Formulation

A nutrient-dense, food-based supplement packaged in single-use 30-gram sachets. The formulation includes green banana flour, chickpea flour, roasted peanut paste, high-oleic oil, whey protein concentrate, micronutrients, and other food ingredients. Participants receive 30 grams daily for 21 days.

DIETARY_SUPPLEMENT

Nutri Listo SQ-LNS

A commercially available small-quantity lipid-based nutrient supplement used in Guatemala for young children. For this study, Nutri Listo is provided in 30-gram sachets with the daily micronutrient amount adjusted for the study. Participants receive 30 grams daily for 21 days.

Sponsors & Collaborators

  • Cooperación Listo Maní+, S.A.

    collaborator UNKNOWN

  • Arizona State University

    collaborator OTHER

  • Wuqu' Kawoq, Maya Health Alliance

    lead OTHER

Principal Investigators

  • Lee Gaeddert, PhD · Wuqu' Kawoq, Maya Health Alliance

  • Wendy Rodriguez, MD · Wuqu' Kawoq, Maya Health Alliance

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Guatemala

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804667 on ClinicalTrials.gov