Measurements From Stool to Support Dietary Change

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.

Study Overview

• Status: Terminated
• Conditions: Feeding Behavior; Diet Habit; Behavior, Health
• Intervention / Treatment: Behavioral: Butyrate Feedback; Behavioral: Fiber Feedback

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University Diet and Fitness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rapid Feedback; Participants received daily feedback on both fiber intake and stool butyrate measurements.	Behavioral: Butyrate Feedback; Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.; Behavioral: Fiber Feedback; Estimated fiber consumption from menu records of weight loss facility.
Active Comparator: Delayed Feedback; 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; Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.; Behavioral: Fiber Feedback; Estimated fiber consumption from menu records of weight loss facility.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Fiber
• Other Study ID Numbers: Pro00094657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No