Recruiting

Cow's Milk & Oat Milk

Sponsor:

Arizona State University

Code:

NCT07839156

Conditions

Gut Microbiome

Neurocognitive Correlates of Eating Habits

Infants and Young Children

Sleep

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Interventions

Daily cow's milk products

Daily Oat Milk Exposure

Study Details

Brief 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.

Conditions

Gut Microbiome

Neurocognitive Correlates of Eating Habits

Infants and Young Children

Sleep

Study ID

NCT07839156

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Jan 30, 2031

Anticipated

Primary completion date

Dec 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cow's Milk

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)).

active comparator: Oat Milk

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)).

Interventions

Daily cow's milk products

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)).

Daily Oat Milk Exposure

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)).

Primary outcome measure

  • Gut Microbiome Diversity [ Time Frame: At enrollment to the end of treatment at 12 months ]
  • Toddler length [ Time Frame: From enrollment to the end of treatment at 12 months ]
  • Toddler weight [ Time Frame: From enrollment to the end of treatment at 12 months ]
  • Vineland Adaptive Behavior Scale (Vinland-3) [ Time Frame: From enrollment to the end of treatment at 12 months ]
  • McArthur Bates Communicative Development Inventories III (MBCDI-III) [ Time Frame: From enrollment to the end of treatment at 12 months ]
  • Mullen Scales of Early Learning [ Time Frame: From enrollment to the end of treatment at 12 months ]
  • Brief Infant Sleep Questionnaire - Extended [ Time Frame: From enrollment to the end of treatment at 12 months ]
  • Sleep-Wake Patterns measured by actigraphy (time awake and 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) [ 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) [ Time Frame: From enrollment to the end of treatment at 12 months ]

Central Contacts and Locations

Central contacts

Corrie M Whisner, PhD

602-496-3348cwhisner@asu.edu

Locations

Arizona State University

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Corrie M Whisner, PhD

602-496-3348cwhisner@asu.edu

More Information

Sponsor

Arizona State University

Last update posted

Nov 5, 2026

Last verified

Sep, 2026

Keywords

  • milk
  • oatmilk
  • toddlers
  • growth
  • development
  • gut microbiome
  • neurocognitive
  • brain health
  • sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.