Actively Recruiting

Phase Not Applicable
Age: 3Months - 6Months
All Genders
Healthy Volunteers
NCT06876935

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

Led by Arizona State University · Updated on 2025-08-27

150

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 3Months - 6Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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; if either parent is allergic to avocado, physician clearance is needed
  • At least one caregiver in the home must have at least an 8th-grade education level
Not Eligible

You will not qualify if you...

  • Infants with growth, chromosomal, or genetic abnormalities, developmental and cognitive impairments, or severe comorbidities affecting growth and development
  • Infants born with congenital abnormalities or developmental delays
  • Infant birth weights less than 2500 g or greater than 4000 g
  • Infants introduced to solid foods prior to 3 months of age
  • Biological mothers with known substance use during pregnancy or who had high-risk pregnancies (e.g., preeclampsia, diabetes, HIV)

AI-Screening

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Trial Site Locations

Total: 1 location

1

College of Health Solutions

Phoenix, Arizona, United States, 85004

Actively Recruiting

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Research Team

C

Corrie M Whisner, PhD

CONTACT

R

Rachel Tribby, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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