NCT01321736已完成不适用
Gut Health Response to a New Fiber Blend
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Stool weight
研究概览
简要总结
Dietary fiber is known to influence bowel function. The investigators hypothesize that the addition of a mixture of fibers to liquid diets will improve bowel function as measured by stool weight.
详细描述
Liquid diets are the sole source of nutrition for many patients. Consumption of liquid diets is linked to lower stool weight. The objective of this study is to feed liquid diets, with and without added fiber, to healthy human subjects to determine if mixed fiber sources can normalize stool weight. Secondary objectives of the study include measurement of gut microbiota and stool chemistry with fiber addition.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 23 - 29
- •having obtained his/her informed consent
- •willing and able to exclusively consume enteral diets for two 14 day periods
- •willing and able to collect stool samples as instructed
排除标准
- •any disease
- •use of medication except for contraceptive medication and certain OTC medications not affecting laxation
- •excessive exercise (> 2 hours per week)
- •consumption of more than 20 grams of dietary fiber daily
- •pregnancy or lactation
- •use of laxatives
- •use of antibiotics in past 6 months
- •use of pre or probiotics supplements in the past 2 months
- •use of probiotic foods in the past month
- •subjects who cannot be expected to comply with the study procedures
- •currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
- •known allergy or sensitivity to formula ingredients
结局指标
主要结局
Stool weight
时间窗: 5 day collection
5 day fecal collection on last 5 days of 14 day feeding trial
次要结局
- fecal microbiota(day 14 of feeding trial)
研究者
研究点 (2)
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