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Measurements From Stool to Support Dietary Change

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Duke University

Status

Terminated

Conditions

Feeding Behavior
Diet Habit
Behavior, Health

Treatments

Behavioral: Butyrate Feedback
Behavioral: Fiber Feedback

Study type

Interventional

Funder types

Other

Identifiers

NCT04037306
Pro00094657

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7 participants in 2 patient groups

Rapid Feedback
Active Comparator group
Description:
Participants received daily feedback on both fiber intake and stool butyrate measurements.
Treatment:
Behavioral: Fiber Feedback
Behavioral: Butyrate Feedback
Delayed Feedback
Active Comparator group
Description:
Participants received daily feedback on fiber intake and one-time feedback on stool butyrate measurements at the end of the study period.
Treatment:
Behavioral: Fiber Feedback
Behavioral: Butyrate Feedback

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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