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
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 will be achieved using a randomized, parallel-arm, clinical trial. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
150
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.
College of Health Solutions
Phoenix, Arizona, United States
RECRUITINGGut 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 months
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 months
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 months
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 months
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 months
Infant length
Infant length will be assessed with a pediatric length board and reported in centimeters.
Time frame: From enrollment to the end of treatment at 6 months
Infant weight
Infant weight will be assessed with a calibrated scale and reported in grams.
Time frame: From enrollment to the end of treatment at 6 months
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