Beyond the Bottle: Investigating the Differential Biological Effects of Cow's Milk and Oat Milk on Toddler Development
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Gut Microbiome Diversity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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)).
干预措施: Daily cow's milk products (Other)
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)).
干预措施: Daily Oat Milk Exposure (Other)
结局指标
主要结局
Gut Microbiome Diversity
时间窗: At enrollment to the end of treatment at 12 months
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.
Toddler length
时间窗: From enrollment to the end of treatment at 12 months
Toddler length will be assessed with a pediatric length board and reported in centimeters.
Toddler weight
时间窗: From enrollment to the end of treatment at 12 months
Infant weight will be assessed with a calibrated scale and reported in grams.
Vineland Adaptive Behavior Scale (Vinland-3)
时间窗: From enrollment to the end of treatment at 12 months
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.
McArthur Bates Communicative Development Inventories III (MBCDI-III)
时间窗: From enrollment to the end of treatment at 12 months
A widely used checklist completed by parents to assess children's early communication skills such as comprehension and use of gestures and words.
Mullen Scales of Early Learning
时间窗: From enrollment to the end of treatment at 12 months
Study staff will administer a structured 15-minute play session with the infant to objectively assess motor, visual, and early language skills.
Brief Infant Sleep Questionnaire - Extended
时间窗: From enrollment to the end of treatment at 12 months
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).
Sleep-Wake Patterns measured by actigraphy (time awake and asleep)
时间窗: From enrollment to the end of treatment at 12 months
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.
Parent-Reported Sleep-Wake Patterns (time awake and asleep, and number of naps and perceived quality of sleep episodes)
时间窗: From enrollment to the end of treatment at 12 months
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.
Home Observation for Measurement of the Environment Inventory (quality and extent of stimulation, support, and learning resources in the home)
时间窗: From enrollment to the end of treatment at 12 months
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.
次要结局
- 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)