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

Recruiting now · Not applicable

Conditions studied: Gut Microbiome, Neurocognitive Correlates of Eating Habits, Infant Growth

In brief

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

Key facts

Study ID

NCT06876935

Run by

Arizona State University

People needed

150

Starts

2025-08-05

Expected to finish

2027-12-31

Last updated by the study team

2025-08-27

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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.)

Where it is running

• College of Health Solutions — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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