Pilot Feasibility of Dietary Heat-Stabilized Rice Bran Supplementation for Diarrheal Disease Prevention in Nicaraguan Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 3
- 主要终点
- Number of participants who are compliant to consuming rice bran daily and in amounts provided
研究概览
简要总结
The purpose is to assess feasibility of rice bran consumption in weaning children and collect pilot data on gut microbiome and metabolome modulation with rice bran intake for diarrheal prevention.
详细描述
Rice bran is a globally accessible, underutilized food ingredient with an array of beneficial nutrients (e.g. phytochemicals and prebiotics) that promote health and potentially prevent diseases. The investigators will determine if dietary rice bran intake can modulate the infant gut microbiome and metabolome to promote gut immunity for the benefit of preventing diarrheal diseases that increase risk for malnutrition and stunting.
The investigators hope to learn about the feasibility of dietary supplementation of heat-stabilized rice bran in weaning children living in regions with increased susceptibility to diarrhea and malnutrition, and whether or not rice bran consumption can modulate the stool microbiome and metabolome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 4 Months 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between the ages of 4 months and 6 months at beginning of recruitment
- •Have received the 3 doses of the rotavirus vaccination (RV5)
- •Families willing to feed their infant a daily dose of study-provided heat-stabilized rice bran for 6 months
排除标准
- •Have had a diarrheal episode between 4 and 6 months of age
- •Have had a prior hospitalization
- •Have had an antibiotic or prophylactic treatment within 1 month prior to participation
- •Have an ongoing illness, a known immunocompromising condition, or use of medications
研究组 & 干预措施
Observational Control
Randomized participants will be observed for diarrhea incidences throughout the 6 month trial with no intervention.
干预措施: Observational Control (Other)
Rice Bran
Randomized participants will consume a measured dose of rice bran daily throughout the 6 month trial.
干预措施: Rice bran (Dietary Supplement)
结局指标
主要结局
Number of participants who are compliant to consuming rice bran daily and in amounts provided
时间窗: 6 months
Record daily rice bran consumption and track compliance to diet intervention by regular visits from local study personnel.
次要结局
- Number of participants with microbial modulations in stool as detected by microbiome sequencing.(6 months)
- Number of participants with metabolite modulations in stool as detected by Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS)(6 months)
研究者
Elizabeth P Ryan
Assistant Professor
Colorado State University