Clinical trial NCT06876935: Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
Official title: Guac & Grow: Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gut Microbiome
Neurocognitive Correlates of Eating Habits
Infant Growth
Keywords: avocado
infants
complimentary feeding
growth
development
gut microbiome
neurocognitive
brain health
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Gut microbiome
timeFrame: At enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Vineland Adaptive Behavior Scale (Vinland-3)
timeFrame: From enrollment to the end of treatment at 6 months
measure: McArthur Bates Communicative Development Inventories III (MBCDI-III)
timeFrame: From enrollment to the end of treatment at 6 months
measure: HOME Assessment
timeFrame: From enrollment to the end of treatment at 6 months
measure: Mullen Scales of Early Learning
timeFrame: From enrollment to the end of treatment at 6 months
measure: Infant length
timeFrame: From enrollment to the end of treatment at 6 months
measure: Infant weight
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
measure: Skin Carotenoid Concentration
timeFrame: From enrollment to the end of treatment at 6 months
measure: Infant 24-hour Diet Records
timeFrame: From enrollment to the end of treatment at 6 months
measure: Food intake photos
timeFrame: From enrollment to the end of treatment at 6 months
measure: Centers for Disease Control Infant Feeding Practices Study II Questionnaire
timeFrame: From enrollment to the end of treatment at 6 months
measure: Food Security Screener
timeFrame: From enrollment to the end of treatment at 6 months
measure: Stool Consistency
timeFrame: From enrollment to the end of treatment at 6 months
Locations:
Study officials:
affiliation: Arizona State University
name: Corrie M Whisner, PhD
role: PRINCIPAL_INVESTIGATOR
References: