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Search / Trial NCT06876935

Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants

Launched by ARIZONA STATE UNIVERSITY · Mar 10, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Avocado Infants Complimentary Feeding Growth Development Gut Microbiome Neurocognitive Brain Health

ClinConnect Summary

This clinical trial is looking at whether giving infants daily avocado can help with their growth and brain and gut health. Researchers want to find out if eating avocados regularly changes the types of good bacteria in a baby’s gut and if it helps improve their motor skills and thinking abilities. They will compare infants who eat avocados every day for six months starting at around six months old with those who do not eat avocados.

To be eligible for this study, infants must be Hispanic or Latine, between 4 to 6 months old, and healthy, without any serious medical issues. Parents should be comfortable giving their baby avocado and keeping track of how much they eat, as well as allowing study staff to visit their home for data collection. The study aims to understand if early exposure to avocados can positively impact infants, and it will also consider family history of allergies when deciding who can participate.

Gender

ALL

Eligibility criteria

  • 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.)

About Arizona State University

Arizona State University (ASU) is a leading research institution dedicated to advancing knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, ASU leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical research aimed at improving patient outcomes and contributing to the scientific community. With a commitment to ethical research practices and collaboration with healthcare professionals, ASU strives to translate research findings into practical applications that benefit society. The university's focus on community engagement and real-world impact underscores its role as a pivotal player in the advancement of clinical research.

Locations

Patients applied

0 patients applied

Trial Officials

Corrie M Whisner, PhD

Principal Investigator

Arizona State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported