Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Whole Gut Transit Time
研究概览
简要总结
Research suggests dietary fiber may decrease transit time through the gastrointestinal tract. Research studies traditionally use radio-opaque markers to determine gastric emptying, colonic transit, and whole gut transit time. The SmartPill is a single use pill that can be used to determine gastric emptying, colonic transit, and whole gut transit time without requiring X-rays or fecal collections. Previous studies have found radio-opaque markers and the SmartPill detect the similar transit times.
The purpose of this pilot study is to determine if the SmartPill can detect a change in transit time using a significant dose of dietary fiber.
详细描述
The ability of a device to track gastrointestinal transit time, including gastric emptying time, was measured in healthy people consuming low and high fiber diets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •Age 18 - 65
- •Non-smoking
- •Not taking medication
- •Non-dieting
- •BMI 18-30
- •English literacy
- •Ability to swallow the SmartPill
排除标准
- •Do not regularly consume breakfast
- •Food allergies to ingredients fond in study products
- •Dislike of hot cereal
- •BMI <18 or >30
- •Are not weight stable
- •Diagnosed with diabetes, cardiovascular, renal, or hepatic disease
- •Cancer in previous 5 years (except basal cell carinoma of the skin)
- •Any gastrointestinal disease or condition
- •Any gastrointestinal surgeries that alter motility
- •Recent antibiotic usage (< 6 months)
- •recent or concurrent participation in an intervention research study
- •History of drug or alcohol abuse in prior 6 months
- •Use of laxatives, anti-diarrheal, antacids, or medications which alter motility
- •Vegetarians
- •People who eat more than approximately 15 grams of fiber per day
- •Currently consume fiber supplements
- •Women who are pregnant or lactating
- •Women with irregular menstrual cycles
结局指标
主要结局
Whole Gut Transit Time
时间窗: 5 days
The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.
次要结局
- Gastrointestinal Tolerance(Day 4)
- Food Intake Diary(Day 1)