Measurements From Stool to Support Dietary Change
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in nutrient intake, as estimated from menu selections
研究概览
简要总结
The purpose of the study is to evaluate if daily feedback on food-derived metabolites in stool enhances an individual's ability to make and/or sustain a dietary change.
详细描述
This is a research study to find out how people respond to information about food-derived compounds measured in their stool.
This study will take place over a three-week period. For these three weeks, participants in a medical weight loss program will be asked to collect samples of their stool daily from Monday to Friday, with optional sampling on weekends. We will measure the amount of butyrate, a breakdown product of fiber, in each sample provided and return this measurement by text message. Participants will be randomized into two groups: one group will have new measurements returned the day after providing each stool sample, and another will have their measurements returned all at once, at the end of the study. Both groups will also receive a daily text message report of their fiber intake, based on the foods they ordered at the weight loss facility cafeteria.
The greatest risks of the study include the possibility of infection while sampling stool, possible gastrointestinal discomfort from changes to the diet, and potential loss of confidentiality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 18 and 80
- •must be a client of the DFC (Duke Diet and Fitness Center) weight loss program for at least four continuous weeks.
- •must have a smartphone
排除标准
- •have diagnosis of Crohn's disease
- •have known stricture (narrowing) of the intestine
- •have any past history of intestinal obstruction
结局指标
主要结局
Change in nutrient intake, as estimated from menu selections
时间窗: Baseline, Week 2, and Week 3
Nutrient intake estimated in grams per day, summed over total menu selections.
次要结局
- Change in butyrate concentration(Baseline, Week 2, and Week 3)