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

A Pilot Study to Evaluate the Acceptability, Tolerability, and Short-Term Biological Signals of a Modified Therapeutic Food Compared to a Standard Lipid-Based Nutrient Supplement in Children Aged 12-24 Months in Rural Guatemala

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.

This randomized, open-label pilot study will compare a modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement currently used in Guatemala. Approximately 36 children aged 12 to 24 months with mild-to-moderate stunting will be enrolled and assigned to one of two study groups.

The modified formulation combines commonly consumed food ingredients and nutrients, including peanut, green banana, chickpea, whey protein, vegetable oil, vitamins, and minerals. The comparison group will receive Nutri Listo. Both groups will receive one 30-gram sachet per day for 21 days.

The study is primarily designed to evaluate whether the modified formulation can be feasibly delivered and is acceptable and well tolerated under home-based conditions. Caregivers will be contacted regularly during the intervention to assess product consumption and gastrointestinal symptoms. Stool samples will be collected near baseline and at the end of the intervention to explore short-term changes in markers of intestinal inflammation, microbial fermentation, and gut microbiome composition.

This pilot is intended to generate feasibility and preliminary biological data that can inform the design of larger studies. It is not powered to determine effects on child growth or other clinical outcomes.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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