RecruitingNot Applicable

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

United States150 participantsStarted 2025-08-05

Plain-language 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

Who can participate

Age range

3 Months – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gut microbiome

Timeframe: At enrollment to the end of treatment at 6 months

Trial details

NCT IDNCT06876935

SponsorArizona State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-31

Contact for this trial

Corrie M Whisner, PhD

602-496-3348 cwhisner@asu.edu

View on ClinicalTrials.gov More Gut Microbiome trials