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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Daily avocado
Other interventionInfants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Daily AvocadoExperimental treatment 1 intervention
Group B: No Avocado ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Gut microbiome
Parents will collect stool samples from infant diapers using sterile swabs (parent will swab a soiled diaper) and backup soiled diapers.
Time frame
At enrollment to the end of treatment at 6 monthsSecondary outcomes
1
Vineland Adaptive Behavior Scale (Vinland-3)
A questionnaire completed by the parent/caregiver that is normed for ages from birth through 90 years. The tool assesses adaptive behaviors (things people do to function in everyday life) in three domains: communication, daily living skills, and socialization.
Time frame
From enrollment to the end of treatment at 6 months2
McArthur Bates Communicative Development Inventories III (MBCDI-III)
A widely used checklist completed by parents to assess children's early communication skills such as comprehension and use of gestures and words.
Time frame
From enrollment to the end of treatment at 6 months3
HOME Assessment
Research personnel will objectively evaluate the caring environment in which a child is raised and parent-child interaction using this validated assessment.
Time frame
From enrollment to the end of treatment at 6 months4
Mullen Scales of Early Learning
Study staff will administer a structured 15-minute play session with the infant to objectively assess motor, visual, and early language skills.
Time frame
From enrollment to the end of treatment at 6 monthsOther outcomes
1
Skin Carotenoid Concentration
The Veggie-Meter, a non-invasive measurement device, will be used to assess the carotenoid content on the index finger of the infant's right hand using reflection spectroscopy via a 2 mm wide white LED light (similar to pulse oximeter measures on the index finger).
Time frame
From enrollment to the end of treatment at 6 months2
Infant 24-hour Diet Records
Habitual intake will be assessed via the Automated Self-Administered 24-hr recall software (ASA24) on 2 weekdays and one weekend day developed by the National Cancer Institute.
Time frame
From enrollment to the end of treatment at 6 months3
Food intake photos
Pre-post meal photos of the infant and their food will be provided by the parents. These images will be used to help corroborate dietary intake and behavior data.
Time frame
From enrollment to the end of treatment at 6 months4
Centers for Disease Control Infant Feeding Practices Study II Questionnaire
This questionnaire asks about breastfeeding, formula feeding, complementary feeding, introduction to solid foods, food allergies, and participation in the Special Supplemental Nutrition Assistance Program for Women, Infant, and Children.
Time frame
From enrollment to the end of treatment at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov