Blueberry Intake and Infant Gut Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Infant Growth (Length)
研究概览
简要总结
The objective of this project is to investigate the effects of blueberries on gut microbiota, inflammation and innate immunity in breastfed infants during early complementary feeding (~5 to 12 months of age).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Months 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy
- •Full term (gestational age ≥ 37 weeks)
- •No prior exposure of solid foods
- •Exclusively breastfed (< 2 weeks of cumulative formula exposure)
- •Willing to consume blueberry/placebo powder
排除标准
- •Having health conditions that would affect normal growth
- •Consumed formula for more than two weeks
- •Not willing to consume the blueberry/placebo powders
结局指标
主要结局
Infant Growth (Length)
时间窗: Over 7 months
Measured in cm
Infant Growth (Weight)
时间窗: Over 7 months
Measured in kg
Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing
时间窗: Over 7 months
16S rRNA amplicon sequencing is used to profile taxonomic makeup of fecal specimens. Within the gut microbiome composition, microbial diversity will be summarized using common ecological measures (Good's coverage, Sobs, and Shannon alpha diversity).
Dietary Intake
时间窗: Over 7 months
3 day dietary recall with results generated by NDSR software
次要结局
- Blueberry-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis(Over 7 months)