NCT04037306

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 30, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

July 26, 2019

Last Update Submit

August 31, 2020

Conditions

Diet HabitFeeding BehaviorBehavior, Health

Keywords

Fiber

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in butyrate concentration

    Baseline, Week 2, and Week 3

Study Arms (2)

Rapid Feedback

ACTIVE COMPARATOR

Participants received daily feedback on both fiber intake and stool butyrate measurements.

Behavioral: Butyrate FeedbackBehavioral: Fiber Feedback

Delayed Feedback

ACTIVE COMPARATOR

Participants received daily feedback on fiber intake and one-time feedback on stool butyrate measurements at the end of the study period.

Behavioral: Butyrate FeedbackBehavioral: Fiber Feedback

Interventions

Butyrate FeedbackBEHAVIORAL

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

Delayed FeedbackRapid Feedback
Fiber FeedbackBEHAVIORAL

Estimated fiber consumption from menu records of weight loss facility.

Delayed FeedbackRapid Feedback

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Diet and Fitness Center

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Feeding BehaviorHealth Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 30, 2019

Study Start

July 30, 2019

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

September 2, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)