Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorArizona State University
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Daily avocado
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov