A Double-blind, Randomized, Crossover Trial to Assess the Gastrointestinal Tolerability of a Dietary Fiber Ingredient in Healthy Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Gastrointestinal tolerability
研究概览
简要总结
The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.
详细描述
The study is a blinded, cross-over design with subjects completing three, two-week treatment periods, separated by two, two-week washouts. Volunteers will consume a dietary fiber for two of the treatment periods at two dose levels. The fiber will be added to foods and dispensed to subjects to be consumed twice a day during each treatment period. During the control period, subjects will receive the same study foods, but with no added fiber. Major outcomes will include fecal weight, and responses to questionnaires that assess fecal characteristics, bowel habits and gastrointestinal tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy men and women
- •age 18 - 54 years
- •BMI < 30 kg/m2
排除标准
- •presence of GI or other serious diseases known to affect GI function
- •recent use of antibiotics
- •very high fiber intake
- •use of medications known to affect GI function
- •presence of allergies to study foods
结局指标
主要结局
Gastrointestinal tolerability
时间窗: subjects will report weekly for 6 weeks
Questionnaire to assess symptoms such as nausea, bloating, and flatulence
次要结局
- Fecal output(subjects will collect fecal output for 12 days within a six-week period)