Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2019-07-30
2020-03-10
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Rapid Feedback
Participants received daily feedback on both fiber intake and stool butyrate measurements.
Butyrate Feedback
Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.
Fiber Feedback
Estimated fiber consumption from menu records of weight loss facility.
Delayed Feedback
Participants received daily feedback on fiber intake and one-time feedback on stool butyrate measurements at the end of the study period.
Butyrate Feedback
Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.
Fiber Feedback
Estimated fiber consumption from menu records of weight loss facility.
Interventions
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Butyrate Feedback
Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.
Fiber Feedback
Estimated fiber consumption from menu records of weight loss facility.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* have known stricture (narrowing) of the intestine
* have any past history of intestinal obstruction
18 Years
80 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Locations
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Duke University Diet and Fitness Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00094657
Identifier Type: -
Identifier Source: org_study_id
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