Measurements From Stool to Support Dietary Change

Not Applicable

Terminated

• Conditions: Feeding Behavior; Behavior, Health; Diet Habit
• Interventions: Behavioral: Butyrate Feedback; Behavioral: Fiber Feedback

• Registration Number: NCT04037306
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-26
• Study Start: 2019-07-30
• Study First Posted: 2019-07-30
• Status Verified: 2019-09
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-10
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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Exclusion Criteria

• have diagnosis of Crohn's disease
• have known stricture (narrowing) of the intestine
• have any past history of intestinal obstruction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid Feedback	Butyrate Feedback	Participants received daily feedback on both fiber intake and stool butyrate measurements.
Delayed Feedback	Fiber Feedback	Participants received daily feedback on fiber intake and one-time feedback on stool butyrate measurements at the end of the study period.
Rapid Feedback	Fiber Feedback	Participants received daily feedback on both fiber intake and stool butyrate measurements.
Delayed Feedback	Butyrate Feedback	Participants received daily feedback on fiber intake and one-time feedback on stool butyrate measurements at the end of the study period.

Primary Outcome Measures

Name	Time	Method
Change in nutrient intake, as estimated from menu selections	Baseline, Week 2, and Week 3	Nutrient intake estimated in grams per day, summed over total menu selections.

Secondary Outcome Measures

Name	Time	Method
Change in butyrate concentration	Baseline, Week 2, and Week 3	Butyrate measurements by gas chromatography, reported in mM (millimolar).

Trial Locations

Locations (1)

Duke University Diet and Fitness Center; 🇺🇸 Durham, North Carolina, United States