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NCT07839156
Tiny Tummies - A Milk Study
Conditions: Gut Microbiome, Neurocognitive Correlates of Eating Habits, Infants and Young Children, Sleep
Sex: All
Ages: 6 Months – 12 Months
Healthy volunteers: Yes
Phase: NA
Enrollment: 150
Sponsor: Arizona State University
Location: Arizona State University Phoenix Arizona
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Children born to mothers 18 years and older while pregnant
* Parents speak English and/or Spanish
* At least one caregiver in the home must have at least an 8th-grade education level
* Children still being breastfed into toddlerhood will be eligible to participate. Breastfeeding frequency and duration will be tracked in this case for statistical model adjustment.
Exclusion Criteria:
* Children regularly taking probiotics and/or antibiotics (e.g., due to chronic ear infections)
* Children with known allergies to cow's milk or oat products
* Children introduced to fluid cow's or oat milk prior to 12 months of age however, yogurt and cheese made from cow's or oat milk will be acceptable and will be quantified for model adjustment during statistical analyses
* Children born with growth, chromosomal, or genetic abnormality, developmental and cognitive impairments, or severe comorbidity that could impact growth and development
* Children born with congenital abnormalities or developmental delays
* Children born with birth weights \4000 g
* Biological mothers must have no known substance use during the child's pregnancy (alcohol, tobacco, marijuana, or illegal drugs)
* Biological mothers who experienced a high-risk pregnancy (e.g., preeclampsia, diabetes-Types 1 and 2 and gestational, HIV, etc.) that affected child growth
* A family history of dairy or gluten (oats are sometimes contaminated with gluten) allergies will be evaluated to assess the child's risk. If either the child's mother or father is allergic to dairy and/or gluten, physician clearance for child participation will be needed
* The toddler's biological parents have heritable diseases that could influence the findings (e.g., autism).
Source: ClinicalTrials.gov (NCT07839156). StuddyBuddy aggregates publicly available trial information.