Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants

Not Applicable

Not yet recruiting

• Conditions: Gut Microbiome; Neurocognitive Correlates of Eating Habits; Infant Growth

• Registration Number: NCT06876935
• Lead Sponsor: Arizona State University

Brief Summary

The goal of this clinical trial is to learn if daily avocado intake can improve growth and brain and gut health in infants. The main questions it aims to answer are:

Does daily eating of avocados change which microbes live in the infant's gut? Does daily avocado intake improve infant motor skills and cognitive development?

Researchers will compare avocado intake to standard of care (no or limited avocado intake) to see if regular avocado intake from 6-12 months of life influences gut and brain health.

Participating mothers/guardians and their infants will:

Parents will provide avocado or no avocado to their infant every day for 6 months starting around 6 months of infant age.

Parents will allow study staff to visit participant homes to collect data via surveys and observations and measure infant growth.

Parents will swab soiled infant diapers for gut microbe measures. Parents will keep a diary of the infant's avocado consumption and acceptance of the food.

Parents will record their infant's dietary intake

Detailed Description

The overarching goal of this two-arm, randomized clinical trial, is to study how early avocado exposure impacts the gut microbiome and developmental milestones in Hispanic infants. The following aims will be achieved using a randomized, parallel-arm, clinical trial.

Specific Aim 1: Evaluate how avocado consumption modulates the infant GM. Hypothesis 1: Daily avocado exposure will produce distinct structural and functional signatures within the GM compared to control.

Specific Aim 2: Investigate how avocado consumption affects emerging motor and neurocognitive skills in infants.

Hypothesis 2: Daily avocado exposure will improve development compared to the control group.

All measures will be completed at participant homes when infants are 6, 9, and 12 months of age. Infants in the intervention arm will receive a daily amount of avocado and the amount consumed will be measured. Those in the control arm will be asked to limit avocado exposure to no more than once per week.

Those in the control arm will receive the same quantity of avocados for 6 months to provide to their child once the 6-month intervention period has been completed so that control infants may also benefit from avocado consumption.

Study Timeline

• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20
• Study Start: 2025-06
• Primary Completion: 2027-10-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 4-6-month-old Hispanic/Latine, non-preterm (>37 weeks gestation) singleton infants
• Infants born to mothers 18 years and older while pregnant
• Parents speak English and/or Spanish
• Families willing to begin feeding infants avocado around 6 months of age or when the infant is ready for solids for a total of 6 months
• Family history of food or latex allergies will be evaluated as avocado is a latex fruit and can cause allergic responses. If either mom or dad is allergic to avocado, physician clearance for infant participation will be needed.
• At least one caregiver in the home must have at least an 8th-grade education level

Exclusion Criteria

• Infants with growth, chromosomal, or genetic abnormality, developmental and cognitive impairments, or severe comorbidity that could impact growth and development
• Infants born with congenital abnormalities or developmental delays
• Infant birth weights <2500 g or >4000 g
• Infants introduced to solid foods prior to 3 months of age
• Biological mothers with known substance use during pregnancy (alcohol, tobacco, marijuana, or illegal drugs), or who experienced a high-risk pregnancy (e.g., preeclampsia, diabetes-Types 1 and 2 and gestational, HIV, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gut microbiome	At enrollment to the end of treatment at 6 months	Parents will collect stool samples from infant diapers using sterile swabs (parent will swab a soiled diaper) and backup soiled diapers.

Secondary Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scale (Vinland-3)	From enrollment to the end of treatment at 6 months	A questionnaire completed by the parent/caregiver that is normed for ages from birth through 90 years. The tool assesses adaptive behaviors (things people do to function in everyday life) in three domains: communication, daily living skills, and socialization.
McArthur Bates Communicative Development Inventories III (MBCDI-III)	From enrollment to the end of treatment at 6 months	A widely used checklist completed by parents to assess children's early communication skills such as comprehension and use of gestures and words.
HOME Assessment	From enrollment to the end of treatment at 6 months	Research personnel will objectively evaluate the caring environment in which a child is raised and parent-child interaction using this validated assessment.
Mullen Scales of Early Learning	From enrollment to the end of treatment at 6 months	Study staff will administer a structured 15-minute play session with the infant to objectively assess motor, visual, and early language skills.
Infant length	From enrollment to the end of treatment at 6 months	Infant length will be assessed with a pediatric length board and reported in centimeters.
Infant weight	From enrollment to the end of treatment at 6 months	Infant weight will be assessed with a calibrated scale and reported in grams.