Recruiting

Avocado Intake

Sponsor:

Arizona State University

Code:

NCT06876935

Conditions

Gut Microbiome

Neurocognitive Correlates of Eating Habits

Infant Growth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Daily avocado

Study Details

Brief summary:

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

Conditions

Gut Microbiome

Neurocognitive Correlates of Eating Habits

Infant Growth

Study ID

NCT06876935

Start date

Aug 5, 2025

Status verified date

Aug, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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.)

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Daily Avocado

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.

no intervention: No Avocado Control

Infants in the control group will be asked to limit avocado exposure to no more than 1/8 of a medium-sized avocado (\~19 g, 2 Tbs) once per week.

Interventions

Daily avocado

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.

Primary outcome measure

  • Gut microbiome [ Time Frame: At enrollment to the end of treatment at 6 months ]

Central Contacts and Locations

Central contacts

Corrie M Whisner, PhD

602-496-3348cwhisner@asu.edu

Rachel Tribby, BS

rtribby@asu.edu

Locations

College of Health Solutions

Recruiting

Phoenix, Arizona, United States, 85004

More Information

Sponsor

Arizona State University

Last update posted

Aug 27, 2025

Last verified

Aug, 2025

Keywords

  • avocado
  • infants
  • complimentary feeding
  • growth
  • development
  • gut microbiome
  • neurocognitive
  • brain health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arizona State University on 2025-08-27.