Measurements From Stool to Support Dietary Change

Study Overview
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Brief Summary
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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
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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.

Official Title
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Measurements From Stool to Support Dietary Change

Conditions
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Diet Habit, Feeding Behavior, Behavior, Health

Intervention / Treatment
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* Behavioral: Butyrate Feedback
* Behavioral: Fiber Feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: have diagnosis of Crohn's disease have known stricture (narrowing) of the intestine have any past history of intestinal obstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rapid Feedback<br>Participants received daily feedback on both fiber intake and stool butyrate measurements. | Behavioral: Butyrate Feedback<br>* Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.<br>Behavioral: Fiber Feedback<br>* Estimated fiber consumption from menu records of weight loss facility.<br>|
| Active Comparator: Delayed Feedback<br>Participants received daily feedback on fiber intake and one-time feedback on stool butyrate measurements at the end of the study period. | Behavioral: Butyrate Feedback<br>* Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.<br>Behavioral: Fiber Feedback<br>* Estimated fiber consumption from menu records of weight loss facility.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nutrient intake, as estimated from menu selections | Nutrient intake estimated in grams per day, summed over total menu selections. | Baseline, Week 2, and Week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in butyrate concentration | Butyrate measurements by gas chromatography, reported in mM (millimolar). | Baseline, Week 2, and Week 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fiber