Tiny Tummies - A Milk Study

N/ANot Yet RecruitingNCT07839156

Arizona State University150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

150

Conditions

Gut Microbiome Neurocognitive Correlates of Eating Habits Infants and Young Children Sleep

Interventions

Daily cow's milk productsOTHER

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 ExposureOTHER

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)).

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Arizona State University

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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

Central Contacts

Corrie M Whisner, PhD

CONTACT

602-496-3348 cwhisner@asu.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Secondary Outcomes

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