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

NCT06876935 | Recruiting

• 2 other identifiers: STUDY00021667AWD00040492
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Gut Microbiome; Neurocognitive Correlates of Eating Habits; Infant Growth

Keywords

avocado; infants; complimentary feeding; growth; development; gut microbiome; neurocognitive; brain health

Outcome Measures

Primary Outcomes (1)

• Gut microbiome

  Parents will collect stool samples from infant diapers using sterile swabs (parent will swab a soiled diaper) and backup soiled diapers.

  At enrollment to the end of treatment at 6 months

Secondary Outcomes (6)

• Vineland Adaptive Behavior Scale (Vinland-3)

  From enrollment to the end of treatment at 6 months

• McArthur Bates Communicative Development Inventories III (MBCDI-III)

  From enrollment to the end of treatment at 6 months

• HOME Assessment

  From enrollment to the end of treatment at 6 months

• Mullen Scales of Early Learning

  From enrollment to the end of treatment at 6 months

• Infant length

  From enrollment to the end of treatment at 6 months

Other Outcomes (6)

• Skin Carotenoid Concentration

  From enrollment to the end of treatment at 6 months

• Infant 24-hour Diet Records

  From enrollment to the end of treatment at 6 months

• Food intake photos

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Daily Avocado

EXPERIMENTAL

Infants in the daily avocado group will receive a daily exposure amount of avocado ranging from 1/4 (\~37.5 g or 1.25 oz) to 1/2 (\~75 g or 2.5 oz) of a medium-sized avocado.

Other: Daily avocado

No Avocado Control

NO INTERVENTION

Infants in the control group will be asked to limit avocado exposure to no more than 1/8 of a medium-sized avocado (\~19 g, 2 Tbs) once per week.

Interventions

Daily avocado OTHER

Infants in the daily avocado group will receive a daily exposure amount of avocado ranging from 1/4 (\~37.5 g or 1.25 oz) to 1/2 (\~75 g or 2.5 oz) of a medium-sized avocado. At 6-8 months, infants will be provided 1/4 (\~37.5 g or 1.25 oz) of a medium-sized avocado for daily consumption. Then from 9-12 months, they will begin receiving 1/2 (\~75 g or 2.5 oz) of a medium-sized avocado for daily consumption.

Daily Avocado

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

College of Health Solutions

Phoenix, Arizona, 85004, United States

RECRUITING

Study Officials

• Corrie M Whisner, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corrie M Whisner, PhD

CONTACT

602-496-3348; cwhisner@asu.edu

Rachel Tribby, BS

CONTACT

rtribby@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 14, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available no earlier than the time of first publication.
• Access Criteria: IPD will be accessible to investigators interested in engaging in secondary data analysis or recreating analyses done by the study team as educational exercises.

Locations

US (1)