Status:
RECRUITING
Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
Lead Sponsor:
Arizona State University
Conditions:
Gut Microbiome
Neurocognitive Correlates of Eating Habits
Eligibility:
All Genders
3-6 years
Phase:
NA
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 cha...
Detailed Description
The overarching goal of this two-arm, randomized clinical trial, is to study how early avocado exposure impacts the gut microbiome and developmental milestones in Hispanic infants. The following aims ...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
August 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06876935
Start Date
August 5 2025
End Date
December 31 2027
Last Update
August 27 2025
Active Locations (1)
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1
College of Health Solutions
Phoenix, Arizona, United States, 85004