Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
NCT ID: NCT06876935
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-08-05
2027-12-31
Brief Summary
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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
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Detailed Description
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Specific Aim 1: Evaluate how avocado consumption modulates the infant GM. Hypothesis 1: Daily avocado exposure will produce distinct structural and functional signatures within the GM compared to control.
Specific Aim 2: Investigate how avocado consumption affects emerging motor and neurocognitive skills in infants.
Hypothesis 2: Daily avocado exposure will improve development compared to the control group.
All measures will be completed at participant homes when infants are 6, 9, and 12 months of age. Infants in the intervention arm will receive a daily amount of avocado and the amount consumed will be measured. Those in the control arm will be asked to limit avocado exposure to no more than once per week.
Those in the control arm will receive the same quantity of avocados for 6 months to provide to their child once the 6-month intervention period has been completed so that control infants may also benefit from avocado consumption.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.)
3 Months
6 Months
ALL
Yes
Sponsors
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Arizona State University
OTHER
Responsible Party
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Corrie Whisner
Associate Professor
Principal Investigators
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Corrie M Whisner, PhD
Role: PRINCIPAL_INVESTIGATOR
Arizona State University
Locations
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College of Health Solutions
Phoenix, Arizona, United States
Countries
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Central Contacts
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Other Identifiers
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AWD00040492
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00021667
Identifier Type: -
Identifier Source: org_study_id
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