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NCT Number: NCT06876935

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

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

Recruiting

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Key information

Age range

3 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Health Solutions

Phoenix, Arizona, 85004, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Daily avocado

Other

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 outcomes

  1. Gut microbiome

    Time frame: At enrollment to the end of treatment at 6 months

    Parents will collect stool samples from infant diapers using sterile swabs (parent will swab a soiled diaper) and backup soiled diapers.

Secondary outcomes

  1. Vineland Adaptive Behavior Scale (Vinland-3)

    Time frame: From enrollment to the end of treatment at 6 months

    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.

  2. McArthur Bates Communicative Development Inventories III (MBCDI-III)

    Time frame: From enrollment to the end of treatment at 6 months

    A widely used checklist completed by parents to assess children's early communication skills such as comprehension and use of gestures and words.

  3. HOME Assessment

    Time frame: From enrollment to the end of treatment at 6 months

    Research personnel will objectively evaluate the caring environment in which a child is raised and parent-child interaction using this validated assessment.

  4. Mullen Scales of Early Learning

    Time frame: From enrollment to the end of treatment at 6 months

    Study staff will administer a structured 15-minute play session with the infant to objectively assess motor, visual, and early language skills.

  5. Infant length

    Time frame: From enrollment to the end of treatment at 6 months

    Infant length will be assessed with a pediatric length board and reported in centimeters.

  6. Infant weight

    Time frame: From enrollment to the end of treatment at 6 months

    Infant weight will be assessed with a calibrated scale and reported in grams.

Other outcomes

  1. Skin Carotenoid Concentration

    Time frame: From enrollment to the end of treatment at 6 months

    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).

  2. Infant 24-hour Diet Records

    Time frame: From enrollment to the end of treatment at 6 months

    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.

  3. Food intake photos

    Time frame: From enrollment to the end of treatment at 6 months

    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.

  4. Centers for Disease Control Infant Feeding Practices Study II Questionnaire

    Time frame: From enrollment to the end of treatment at 6 months

    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.

  5. Food Security Screener

    Time frame: From enrollment to the end of treatment at 6 months

    The USDA 6-Item Food Security Screener will be used to assess household food insecurity.

  6. Stool Consistency

    Time frame: From enrollment to the end of treatment at 6 months

    Parents will be asked to classify the stool consistency using the picture-based Brussels Infant and Toddler Stool Scale (BITSS), developed specifically for non-toilet-trained children.

Study contacts

Contact information is provided by the study sponsor or research team.

Corrie M Whisner, PhD

CONTACT

[email protected]

602-496-3348

Rachel Tribby, BS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

Guac & Grow: Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants

Acronym: Guac & Grow

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 14, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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