Trials / Terminated
TerminatedNCT04037306
Measurements From Stool to Support Dietary Change
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Butyrate Feedback | Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report. |
| BEHAVIORAL | Fiber Feedback | Estimated fiber consumption from menu records of weight loss facility. |
Timeline
- Start date
- 2019-07-30
- Primary completion
- 2020-03-10
- Completion
- 2020-03-10
- First posted
- 2019-07-30
- Last updated
- 2020-09-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04037306. Inclusion in this directory is not an endorsement.