Skip to content

Measurements From Stool to Support Dietary Change

Measurements From Stool to Support Dietary Change

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04037306
Enrollment
7
Registered
2019-07-30
Start date
2019-07-30
Completion date
2020-03-10
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Health, Diet Habit, Feeding Behavior

Keywords

Fiber

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.

Interventions

BEHAVIORALButyrate Feedback

Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.

BEHAVIORALFiber Feedback

Estimated fiber consumption from menu records of weight loss facility.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in nutrient intake, as estimated from menu selectionsBaseline, Week 2, and Week 3Nutrient intake estimated in grams per day, summed over total menu selections.

Secondary

MeasureTime frameDescription
Change in butyrate concentrationBaseline, Week 2, and Week 3Butyrate measurements by gas chromatography, reported in mM (millimolar).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026