Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Gut Microbiome Composition Analyzed using 16S rRNA Amplicon Sequencing
研究概览
简要总结
The objective is to investigate the effect of walnuts on gut microbiota, inflammatory markers, atopic dermatitis status, and indices of allergy outcomes in breastfed infants during early complementary feeding.
The three primary aims include:
Aim 1: Evaluate the effect of walnut consumption on gut microbiota structure and function, inflammation, atopic dermatitis, and allergy outcomes.
Aim 2: Evaluate the impact of walnut consumption on infant growth trajectories and risk of overweight.
Aim 3 (exploratory): Identify walnut-specific food signatures that are associated with gut microbiota and immunity biomarkers using a novel nutri-metabolomics technique.
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
- Factorial
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Months 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term: gestational age ≥ 37 weeks
- •Generally healthy without conditions that would affect normal growth
- •No significant consumption of complementary food (e.g., no more than 1 oz of solid foods per week)
- •Exclusively breastfed (< 2 weeks of cumulative formula exposure)
排除标准
- •Adults unable to consent
- •Pregnant women
- •Prisoners
研究组 & 干预措施
The walnut group
The intervention group will provide 10g of walnuts daily to their infant for 7 months.
干预措施: Infant walnut intake (Other)
Control Group
The control group will be asked to limit walnuts and tree nuts.
结局指标
主要结局
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).
Infant Growth (Length)
时间窗: Over 7 months
Measured in cm
Infant Growth (Weight)
时间窗: Over 7 months
Measured in kg
Dietary Intake
时间窗: Over 7 months
3 day dietary recall with results generated by NDSR software
IL-33 (Interleukin-33)
时间窗: Over 7 months
Measured in pg/mL
IL-6 (Interleukin-6)
时间窗: Over 7 months
Measure in pg/mL
IL-8 (Interleukin-8)
时间窗: Over 7 months
Measured in pg/mL
IL-13 (Interleukin-13)
时间窗: Over 7 months
Measured in pg/mL
TGF-b (Transforming growth factor beta)
时间窗: Over 7 months
Measured in ng/ml.
IL-4 (Interleukin-4)
时间窗: Over 7 months
Measured in pg/mL
IL-10 (Interleukin 10)
时间窗: Over 7 months
Measured in pg/mL
次要结局
- Walnut-Specific Food Signatures (Compounds) as Assessed by Metabolomics Analysis(Over 7 months)