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| ID | Type | Description | Link |
|---|---|---|---|
| AWD00040492 | Other Grant/Funding Number | Avocado Nutrition Center |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome | Parents will collect stool samples from infant diapers using sterile swabs (parent will swab a soiled diaper) and backup soiled diapers. | At enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Carotenoid Concentration | 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). | From enrollment to the end of treatment at 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corrie M Whisner, PhD | Contact | 602-496-3348 | cwhisner@asu.edu | |
| Rachel Tribby, BS | Contact | rtribby@asu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Corrie M Whisner, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Health Solutions | Recruiting | Phoenix | Arizona | 85004 | United States |
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.
IPD and supporting information will be available no earlier than the time of first publication.
IPD will be accessible to investigators interested in engaging in secondary data analysis or recreating analyses done by the study team as educational exercises.
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| 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. | 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. | 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. | 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. | 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. | From enrollment to the end of treatment at 6 months |
| Infant 24-hour Diet Records |
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. |
| From enrollment to the end of treatment at 6 months |
| Food intake photos | 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. | From enrollment to the end of treatment at 6 months |
| Centers for Disease Control Infant Feeding Practices Study II Questionnaire | 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. | From enrollment to the end of treatment at 6 months |
| Food Security Screener | The USDA 6-Item Food Security Screener will be used to assess household food insecurity. | From enrollment to the end of treatment at 6 months |
| Stool Consistency | 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. | From enrollment to the end of treatment at 6 months |