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

NCT07804667 | Not Yet Recruiting

• 1 other identifier: WK 2026 003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Childhood stunting; Therapeutic food; Small-quantity lipid-based nutrient supplement; Gut microbiome; Environmental enteric dysfunction; Guatemala

Outcome Measures

Primary Outcomes (3)

• Acceptability and palatability of the study product

  Acceptability and palatability will be assessed using structured study questionnaires. During the initial taste test, staff will record the amount of modified therapeutic food consumed, observed feeding behavior, and whether the caregiver believes the child would eat the product every day. At endline, caregivers will rate overall acceptance of the assigned study product on a 4-point scale: refused most of the time, accepted with difficulty, accepted well, or liked it very much.

  Initial taste test (Day 0) and endline assessment (Day 22)

• Adherence to daily study product consumption

  Adherence will be assessed during scheduled WhatsApp or telephone monitoring contacts using caregiver reports of whether the child consumed all, some, or none of the assigned product. At endline, staff will count remaining sachets and collect used sachets or wrappers to estimate product consumption during the 21-day home-feeding period.

  Days 1 through 21, with endline assessment on Day 22

• Frequency and severity of gastrointestinal symptoms

  During scheduled monitoring contacts, caregivers will report gastrointestinal symptoms occurring since the previous contact, including stomach pain, diarrhea or loose stools, vomiting, and bloating or gas. Symptom severity will be recorded as none, mild, or severe, and the specific symptom type will be documented when symptoms are reported.

  Days 1 through 21

Secondary Outcomes (7)

• Change in fecal calprotectin concentration

  Baseline to endline (Day 22)

• Change in fecal short-chain fatty acid concentrations

  Baseline to endline (Day 22)

• Directional change in gut microbiome composition

  Baseline to endline (Day 22)

• Fecal pH

  Baseline and endline (Day 22)

• Fecal sIgA

  Baseline and endline (Day 22)

Study Arms (2)

Modified Therapeutic Food Formulation

EXPERIMENTAL

Participants will receive one 30-gram sachet of the modified therapeutic food formulation daily for 21 days. During the first 3 days, caregivers will divide the daily sachet into two approximately 15-gram servings. From Day 4 onward, the full daily amount may be given at one time or divided based on caregiver preference.

Dietary Supplement: Modified Therapeutic Food Formulation

Nutri Listo SQ-LNS

ACTIVE COMPARATOR

Participants will receive one 30-gram sachet of Nutri Listo small-quantity lipid-based nutrient supplement daily for 21 days, with micronutrients adjusted for the study daily total. During the first 3 days, caregivers will divide the daily sachet into two approximately 15-gram servings. From Day 4 onward, the full daily amount may be given at one time or divided based on caregiver preference.

Dietary Supplement: Nutri Listo SQ-LNS

Interventions

Nutri Listo SQ-LNS DIETARY_SUPPLEMENT

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.

Also known as: Nutri Listo

Nutri Listo SQ-LNS

Modified Therapeutic Food Formulation DIETARY_SUPPLEMENT

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.

Modified Therapeutic Food Formulation

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 12 to 24 months at enrollment
• Mild-to-moderate stunting, defined as height-for-age Z-score (HAZ) less than -1 and greater than -3
• Primary caregiver willing and able to provide informed consent
• Caregiver has access to a phone or WhatsApp, or has a trusted proxy such as a family member or neighbor who can assist with phone calls or WhatsApp communication

You may not qualify if:

• Moderate or severe acute malnutrition, defined as weight-for-height Z-score (WHZ) less than -2
• Antibiotic use within the preceding 14 days
• Known food allergy or intolerance to study ingredients, including peanut, dairy, or egg
• History of persistent diarrhea, defined as watery stools lasting more than 7 consecutive days within the past month
• Caregiver report of frequent or severe abdominal distension or pain occurring shortly after consumption of fiber-rich foods

Sponsors & Collaborators

• Wuqu' Kawoq, Maya Health Alliance: lead
• Cooperación Listo Maní+, S.A.: collaborator
• Arizona State University: collaborator

Study Sites (1)

Centro Comunitario de Salud Chuti Estancia

San Andrés Semetabaj, Departamento de Sololá, Guatemala

Location

Study Officials

• Lee Gaeddert, PhD

  Wuqu' Kawoq, Maya Health Alliance

  PRINCIPAL INVESTIGATOR

• Wendy Rodriguez, MD

  Wuqu' Kawoq, Maya Health Alliance

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee E Gaeddert, PhD

CONTACT

620-543-5246; Lee.Gaeddert@asu.edu

Wendy Rodriguez, MD

CONTACT

+502 3029-1150; wendyrodriguez@wuqukawoq.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to one of two parallel study arms: a modified food supplement or the Nutri Listo small-quantity lipid-based nutrient supplement comparator. Each participant receives the assigned product for 21 days.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning at publication of the primary study results and available for 5 years thereafter. Microbiome sequencing data will be deposited in an appropriate public repository at or before publication when required by the journal.
• Access Criteria: Qualified researchers may request de-identified participant-level data underlying published results from the study investigators for scientifically appropriate secondary analyses. Requests will be reviewed for consistency with participant consent, ethics and privacy requirements, and the proposed scientific use. A data-use agreement may be required. Publicly deposited microbiome sequencing data and limited non-identifying metadata will be accessible through the repository identified in the resulting publication.

Locations

GU (1)