Gut MicrobiomeGuac & GrowNCT06876935
Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
A study testing Daily avocado in people with Gut Microbiome and Neurocognitive Correlates of Eating Habits, run by Arizona State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Neurocognitive Correlates of Eating Habits, Infant Growth
- What is being tested?
- Daily avocado
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rachel Tribby, BS contact
United States1 site, 1 recruiting
- Recruiting
College of Health Solutions
Phoenix, Arizona, 85004
About this study
Official title: Guac & Grow: 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?
Read more
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
Read the detailed description
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.
- Being tested
- Daily avocado
- Keywords
- avocado, infants, complimentary feeding, growth, development, gut microbiome, neurocognitive, brain health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily avocadoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Daily Avocado | Experimental | 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. Receives: Other: Daily avocado |
| No Avocado Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome
Parents will collect stool samples from infant diapers using sterile swabs (parent will swab a soiled diaper) and backup soiled diapers.
Measured: At enrollment to the end of treatment at 6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start5 Aug 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corrie Whisner, Arizona State University
- Investigators
- Corrie M Whisner, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876935
- Sponsor's protocol ID
- STUDY00021667
- Other IDs
- AWD00040492
- Acronym
- Guac & Grow
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To comply with the rigor and reproducibility goals of the scientific community, we will make data available when required for publication in peer-reviewed scholarly journals. Any data shared for publication will be shared in repositories such as those managed by the U.S. government (e.g. dbGAP for microbiome sequence files and associated phenotype metadata) or Arizona State University. Data will be shared with the sponsor and made available for secondary data analyses upon reasonable investigator request. Further study protocols will be made available upon request to the PI and analytical code and statistical analyses will be shared through GitHub.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guac & Grow: Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants
- ClinicalTrials.gov ID
- NCT06876935
- Acronym / sponsor ID
- Guac & Grow / STUDY00021667
- Keywords
- avocado, infants, complimentary feeding, growth, development, gut microbiome, neurocognitive, brain health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Avocado | Experimental | Other: Daily avocadoInfants 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 Avocado Control | No intervention | –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. |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily avocadoInfants 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. | Other | Daily Avocado |
Primary outcome
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.
6 secondary outcomes
Vineland Adaptive Behavior Scale (Vinland-3)
Time frame: From enrollment to the end of treatment at 6 months
McArthur Bates Communicative Development Inventories III (MBCDI-III)
Time frame: From enrollment to the end of treatment at 6 months
HOME Assessment
Time frame: From enrollment to the end of treatment at 6 months
Mullen Scales of Early Learning
Time frame: From enrollment to the end of treatment at 6 months
Infant length
Time frame: From enrollment to the end of treatment at 6 months
Infant weight
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. To comply with the rigor and reproducibility goals of the scientific community, we will make data available when required for publication in peer-reviewed scholarly journals. Any data shared for publication will be shared in repositories such as those managed by the U.S. government (e.g. dbGAP for microbiome sequence files and associated phenotype metadata) or Arizona State University. Data will be shared with the sponsor and made available for secondary data analyses upon reasonable investigator request. Further study protocols will be made available upon request to the PI and analytical code and statistical analyses will be shared through GitHub.
Related trials for Gut Microbiome
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Tribby, BS contact
Corrie M Whisner, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily avocado in people with Gut Microbiome and Neurocognitive Correlates of Eating Habits, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corrie M Whisner, PhD (602-496-3348, cwhisner@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome (time frame: At enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.