Measurements From Stool to Support Dietary Change

Diet Habit Clinical Trial

Official title:

Measurements From Stool to Support Dietary Change

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04037306
• Other study ID #: Pro00094657
• Status: Terminated
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: September 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Health
• Diet Habit
• Feeding Behavior

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke University Diet and Fitness Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in butyrate concentration	Butyrate measurements by gas chromatography, reported in mM (millimolar).	Baseline, Week 2, and Week 3