Health Benefits and Tolerance of Dietary Fiber Supplements in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in stool consistency
研究概览
简要总结
The investigators hypothesize that fiber supplementation will provide measurable differences in indices of children's health (fewer complaints of abdominal pain and constipation, lower body mass index) compared to placebo.
详细描述
This prospective study proposes supplementing children with fiber or placebo for four months. Children in elementary school, ages 5-12, will be randomized to receive fiber supplemented bars vs low-fiber snack bars (placebo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children bewteen ages of 5-12 years
排除标准
- •History of allergy/intolerance to components of the snack bars (e.g. celiac disease)
- •History of Hisrchsprungs disease, abdominal surgery to intestine or colon
- •Unable to take a fiber bar by mouth
研究组 & 干预措施
Fiber
干预措施: Fiber (Dietary Supplement)
Placebo
干预措施: Placebo (low fiber bar) (Other)
结局指标
主要结局
Change in stool consistency
时间窗: 4 months
Stool consistency (using the Bristol scale) will be compared between baseline and study end in each group
Change in stool frequency
时间窗: 4 months
Weekly stool frequency will be compared between baseline and study end in each group
次要结局
- Change in weight(4 months)
- Change in quality of life score(4 months)