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

NCT06876935 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-08-27

No results posted yet for this study

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

Interventions

OTHER

Daily avocado

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.

Sponsors & Collaborators

  • Arizona State University

    lead OTHER

Principal Investigators

  • Corrie M Whisner, PhD · Arizona State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06876935 on ClinicalTrials.gov