Potato Fiber and Gastrointestinal Function: Phase 3 (Grant #94521)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Stool Frequency
研究概览
简要总结
The primary physiological impacts of fiber intake include the gastrointestinal effects of stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT). Fermentation of resistant starches by microbiota increases bacterial numbers, which increases fecal bulk and may impact frequency and transit time. The purpose of this study is to determine the effects of resistant potato starches (potato fiber) on stool frequency, transit time and microbiota in healthy individuals.
详细描述
Potato fiber (PF-RS, PF-RO1 and PF-RO2), supplemented in the diet of healthy individuals (n=60; 20 per group) and providing 30 g per day of fiber, will result in a significant changes in gastrointestinal function and microbiota profile.
Objectives:
- To determine the effect of potato fibers on stool frequency, gastrointestinal transit time and gastrointestinal symptoms.
- To determine the effect of potato fibers on microbial diversity in healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •must be between the ages of 18 and
- •must be willing to complete daily questionnaires.
- •must be willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
- •must have internet access for the duration of the study
- •must have usual fiber intake of <20 g/d based on Food Frequency Questionnaire such as the Block Fruit/Vegetable/Fiber Screener
- •must be willing to consume kool-aid everyday for 2 periods of 14 days
- •must be willing to provide stool samples
排除标准
- •must not have a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy other than GERD, constipation, diverticular disease)
- •must not have a food allergy
- •must not take dietary supplements (prebiotic and fiber supplements)
结局指标
主要结局
Stool Frequency
时间窗: 6 weeks
Change in stool frequency determined by the daily questionnaire
次要结局
- Gastrointestinal transit time(6 weeks)
- Microbial diversity(6 weeks)
- Gastrointestinal symptoms(6 weeks)