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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Arizona State University
Study ID
NCT06876935
Status
Recruiting
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Conditions

  • Gut Microbiome
  • Infant Growth
  • Neurocognitive Correlates of Eating Habits

Eligibility Criteria

Sex
ALL
Age
3 Months - 6 Months
Healthy Volunteers
Accepted

Interventions

  • Daily avocado — OTHER
    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.

Study Details

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 Dates

Start date
Aug 5, 2025
Status verified
Aug 2025
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • No Intervention: No Avocado Control
    Infants in the control group will be asked to limit avocado exposure to no more than 1/8 of a medium-sized avocado (\~19 g, 2 Tbs) once per week.

Primary Outcome Measure

Gut microbiome [ Time Frame: At enrollment to the end of treatment at 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
College of Health SolutionsPhoenixArizona85004-

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By research site
College of Health Solutions· Phoenix, AZ

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