Daily avocado from 6–12 months and infant gut, growth, and development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm, randomized, parallel-group trial enrolling term Hispanic/Latine infants to compare daily avocado feeding with usual/limited avocado exposure from roughly 6 to 12 months of age. Families will be randomized to provide a measured daily amount of avocado or to limit avocado to no more than once per week, with home visits and data collection at 6, 9, and 12 months. Outcomes include diaper swab measures of the gut microbiome, standardized assessments of motor and neurocognitive milestones, growth measurements, feeding diaries, and caregiver surveys. Control families are offered the same quantity of avocado after the 6-month intervention so they may also benefit.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* 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 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
* 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.)

Where it's running

• College of Health Solutions
  Phoenix, Arizona, United States Recruiting

Study contacts

• Principal investigator: Corrie M Whisner, PhD — Arizona State University
• Study coordinator: Corrie M Whisner, PhD
• Email: cwhisner@asu.edu
• Phone: 602-496-3348

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.