An interventional study of Daily cow's milk products and Daily Oat Milk Exposure in Gut Microbiome, Neurocognitive Correlates of Eating Habits and Infants and Young Children, sponsored by Arizona State University. Recruiting at 1 site in United States. Open to participants aged 6 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Arizona State University · Not applicable, Interventional, and Prevention
This is a 12-month, 2-arm randomized controlled trial (n=150) examining whether toddlers randomized at 12 months of age to 1.5 cup-equivalents/day of cow's milk-based dairy versus oat milk-based dairy, and followed to 24 months, have better growth, sleep, neurocognitive, and gut microbiome outcomes.
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's planned enrollment of 150 is above the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Toddlers in the cow's milk group will receive 1.5 cup equivalents per day of cow-based dairy (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1/2 cup)).
Other: Daily cow's milk products
Toddlers in the oat milk group will receive 1.5 cup equivalents per day of oat milk (1 cup fluid oat milk) + ½ cup equivalent of oat-based cheese (0.75 oz.) or yogurt (1/2 cup)).
Other: Daily Oat Milk Exposure
Toddlers in the cow's milk group will receive 1.5 cup equivalents per day of cow-based dairy (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1/2 cup)).
Toddlers in the oat milk group will receive 1.5 cup equivalents per day of oat milk (1 cup of fluid milk + ½ cup equivalent of cheese (0.75 oz.) or yogurt (1/2 cup)).
Gut Microbiome Diversity
Microbial DNA extracted from toddler stool samples will undergo shotgun metagenomic sequencing to identify the unique species present in the gut microbial community and evaluate the richness and abundance of microbes present in the stool.
Time frame: At enrollment to the end of treatment at 12 months
Toddler length
Toddler length will be assessed with a pediatric length board and reported in centimeters.
Time frame: From enrollment to the end of treatment at 12 months
Toddler weight
Infant weight will be assessed with a calibrated scale and reported in grams.
Time frame: From enrollment to the end of treatment at 12 months
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.
Time frame: From enrollment to the end of treatment at 12 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.
Time frame: From enrollment to the end of treatment at 12 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.
Time frame: From enrollment to the end of treatment at 12 months
Brief Infant Sleep Questionnaire - Extended
Sleep location, duration, quality, and interactions; validated for infants and toddlers through age 3 years; REDCap online. Scores range from 0-100 with higher scores representing healthier, more consolidated sleep patterns (e.g., shorter time to fall asleep, fewer and shorter night wakings).
Time frame: From enrollment to the end of treatment at 12 months
Sleep-Wake Patterns measured by actigraphy (time awake and asleep)
Actigraphy is a standard, valid, noninvasive measure for assessing sleep and circadian rhythm patterns across the life course. For infants and young children (e.g., toddlers), the actigraph is a small watch-like device that will be worn around the left ankle to record body motion (activity counts). The child will wear the devices for 7 continuous days and nights after all in-home visits. Constant assessment is necessary to capture the full development of sleep-wake patterns and circadian rhythmicity across toddlerhood. Home visits will be scheduled to avoid current illnesses or well-visits to avoid vaccination effects on sleep patterns. Primary sleep variables will be averaged across the recording period. Data will be reported in minutes of time that the child is awake or asleep.
Time frame: From enrollment to the end of treatment at 12 months
Parent-Reported Sleep-Wake Patterns (time awake and asleep, and number of naps and perceived quality of sleep episodes)
During actigraphy data collection, the parent/guardian will complete sleep diaries on the sleep of their toddler. Diaries will be used to identify artifacts that might affect motion (externally induced motion e.g. car seat, swing, or constricted motion e.g. swaddling), and to define sleep periods from actigraphy outputs for children prior to analysis with the sleep-wake algorithms. Primary sleep diary variables will be (1) bed/nap clock times attempted to sleep, (2) bed/nap clock times of sleep bout awakenings, and (3) time in bed or interval between attempted bed and wake times.
Time frame: From enrollment to the end of treatment at 12 months
Home Observation for Measurement of the Environment Inventory (quality and extent of stimulation, support, and learning resources in the home)
Research personnel will objectively evaluate the caring environment in which a child is raised and parent-child interaction using this validated assessment. The inventory qualitatively assesses the quality and extent of stimulation, support, and learning resources available in a child's home environment.
Time frame: From enrollment to the end of treatment at 12 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.
Time frame: From enrollment to the end of treatment at 12 months
Food intake photos showing the infant consuming intervention foods (compliance measure)
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.
Time frame: From enrollment to the end of treatment at 12 months
Centers for Disease Control Infant Feeding Questionnaire to assess feeding practices in toddlerhood
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.
Time frame: From enrollment to the end of treatment at 12 months
Food Security Screener
The USDA 6-Item Food Security Screener will be used to assess household food insecurity. Scores range from 0-6 with higher scores representing higher levels of food insecurity.
Time frame: From enrollment to the end of treatment at 12 months
Comprehensive Early Childhood Allergy Questionnaire
Will be used to evaluate allergy exposures and risk across the study period. This is a checklist of various common allergies that parents report the child having or not having each allergy.
Time frame: From enrollment to the end of treatment at 12 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.
Time frame: From enrollment to the end of treatment at 12 months
Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers
To assess children's experiences of gastrointestinal and gastroesophageal reflux symptoms. A total score is calculated as a sum of responses from 36 questions. Higher scores indicate greater symptom burden, and scores range from 0 to 180
Time frame: From enrollment to the end of treatment at 12 months
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD and supporting information will be available no earlier than the time of first publication.
Access criteria: IPD will be accessible to investigators interested in engaging in secondary data analysis or recreating analyses done by the study team as educational exercises.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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