The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
The overall objective of this project is to understand how consuming a prescribed diet of different infant foods (which may contain cereals,fruits, vegetables, meats, dairy) during the time of early complementary feeding (~5 to 12 months) in breastfed infants has on growth trajectories, neurodevelopment and sleep patterns in relation to gut microbiota, compared with a traditional diet that is usually provided in the home to infants.
The three primary aims include:
Aim 1: Identify the effects that the prescribed early complementary feeding specific study diet has on growth trajectories in breastfed infants.
Aim 2: Identify whether the relationship between the prescribed early complementary feeding specific study diet and growth is mediated by gut microbiota.
Aim 3: Characterize infant neurodevelopment and sleep patterns.
详细描述
Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 5 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term: gestational age > 37 weeks
- •Exclusively breastfed (< 2 weeks of cumulative formula exposure). Any formula consumption on a given day is considered one day of formula exposure. During the intervention, if the participant receives more than 50% of the liquid diet from infant formula, s/he will be excluded from the study.
- •Maternal conditions such as gestational diabetes mellitus, preeclampsia, multiple pregnancies are acceptable.
排除标准
- •Large for gestational age or small for gestational age
- •Antibiotic use from birth to the time of enrollment
- •Documented food allergies
- •Previous complementary food exposure
- •Conditions that would affect protein metabolism or growth
结局指标
主要结局
Weight
时间窗: Over 6 months
Measured in kg
Length
时间窗: Over 6 months
Measured in cm
Gut Microbiome
时间窗: Over 6 months
Gut microbiota structure by 16S sequencing
次要结局
- Total calories in breast milk(Over 6 months)
- Neurodevelopment(At 12 months of age)
- Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)(Over 6 months)
- Total protein in breast milk(Over 6 months)
- Body composition(Over 6 months)
- Dietary intake(Over 6 months)
- Duration of sleep(Over 6 months)
- Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)(Over 6 months)
- Serum c-reactive protein (CRP-hs)(Over 6 months)
- Total carbohydrates in breast milk(Over 6 months)
- Total fat in breast milk(Over 6 months)