Tiny Tummies - A Milk Study

NCT07839156 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00024490
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (5)

• Infant 24-hour Diet Records

  From enrollment to the end of treatment at 12 months

• Food intake photos showing the infant consuming intervention foods (compliance measure)

  From enrollment to the end of treatment at 12 months

• Centers for Disease Control Infant Feeding Questionnaire to assess feeding practices in toddlerhood

  From enrollment to the end of treatment at 12 months

• Food Security Screener

  From enrollment to the end of treatment at 12 months

• Comprehensive Early Childhood Allergy Questionnaire

  From enrollment to the end of treatment at 12 months

Other Outcomes (2)

• Stool Consistency

  From enrollment to the end of treatment at 12 months

• Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Cow's Milk

EXPERIMENTAL

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

Oat Milk

ACTIVE COMPARATOR

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

Interventions

Daily cow's milk products OTHER

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)).

Cow's Milk

Daily Oat Milk Exposure OTHER

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)).

Oat Milk

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Central Study Contacts

Corrie M Whisner, PhD

CONTACT

602-496-3348; cwhisner@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 24, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): January 30, 2031
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US (1)