Tiny Tummies: Milk vs. Oat Milk for Toddlers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized controlled trial enrolling 150 children to compare daily cow’s milk–based dairy with daily oat milk–based dairy from age 12 months to 24 months. Participants are assigned to one of two dairy approaches and will be followed for growth, sleep patterns, neurocognitive development, and gut microbiome composition. The study collects data on breastfeeding status and other factors to adjust analyses. The trial is conducted at Arizona State University in Phoenix and is led by ASU with no listed collaborators. Outcomes will inform whether the type of dairy consumed in toddlerhood influences early development and gut health.

Why it matters

Who can join: the full rules

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 \<2500 g or \>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).

Where it's running

• Arizona State University
  Phoenix, Arizona, United States Recruiting

Study contacts

• Study coordinator: Corrie M Whisner, PhD
• Email: cwhisner@asu.edu
• Phone: 602-496-3348

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.