Tiny Tummies - A Milk Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorArizona State University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Daily cow's milk products
Other interventionToddlers 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
Other interventionToddlers 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)).
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Cow's MilkExperimental treatment 1 intervention
Group B: Oat MilkActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsOther outcomes
1
Stool Consistency
Parents will be asked to classify the stool consistency using the picture-based Brussels Infant and Toddler Stool Scale (BITSS), developed specifically for non-toilet-trained children.
Time frame
From enrollment to the end of treatment at 12 months2
Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers
To assess children's experiences of gastrointestinal and gastroesophageal reflux symptoms. A total score is calculated as a sum of responses from 36 questions. Higher scores indicate greater symptom burden, and scores range from 0 to 180
Time frame
From enrollment to the end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: