Diet HabitNCT04037306
Measurements From Stool to Support Dietary Change
A study testing Butyrate Feedback and Fiber Feedback in people with Diet Habit and Feeding Behavior, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diet Habit, Feeding Behavior, Behavior, Health
- What is being tested?
- Butyrate Feedback and Fiber Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- have diagnosis of Crohn's disease
- have known stricture (narrowing) of the intestine
- have any past history of intestinal obstruction
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Diet and Fitness Center
Durham, North Carolina, 27708
About this study
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.
Read the 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.
- Conditions
- Diet Habit, Feeding Behavior, Behavior, Health
- Being tested
- Butyrate Feedback, Fiber Feedback
- Keywords
- Fiber
- Medical subject headings
- Feeding Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butyrate FeedbackBehavioural
Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.
Fiber FeedbackBehavioural
Estimated fiber consumption from menu records of weight loss facility.
| Study group | Role | What they receive |
|---|---|---|
| Rapid Feedback | Active comparator | Participants received daily feedback on both fiber intake and stool butyrate measurements. Receives: Behavioral: Butyrate Feedback; Behavioral: 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. Receives: Behavioral: Butyrate Feedback; Behavioral: Fiber Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nutrient intake, as estimated from menu selections
Nutrient intake estimated in grams per day, summed over total menu selections.
Measured: Baseline, Week 2, and Week 3
Secondary outcomes (1)
Change in butyrate concentration
Butyrate measurements by gas chromatography, reported in mM (millimolar).
Measured: Baseline, Week 2, and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start30 Jul 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Why it stopped: Weight loss center programming suspended due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037306
- Sponsor's protocol ID
- Pro00094657
- Status last verified
- Sep 2019
- First submitted
- 26 Jul 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements From Stool to Support Dietary Change
- ClinicalTrials.gov ID
- NCT04037306
- Acronym / sponsor ID
- Pro00094657
- Conditions
- Diet Habit, Feeding Behavior, Behavior, Health
- Keywords
- Fiber
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Weight loss center programming suspended due to COVID-19 pandemic
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid Feedback | Active comparator | Behavioral: Butyrate Feedback, Behavioral: Fiber FeedbackParticipants received daily feedback on both fiber intake and stool butyrate measurements. |
| Delayed Feedback | Active comparator | Behavioral: Butyrate Feedback, Behavioral: Fiber FeedbackParticipants received daily feedback on fiber intake and one-time feedback on stool butyrate measurements at the end of the study period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- have diagnosis of Crohn's disease
- have known stricture (narrowing) of the intestine
- have any past history of intestinal obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Butyrate FeedbackMeasure concentrations of stool butyrate by gas chromatography, returned to participants in summary report. | Behavioural | Delayed Feedback, Rapid Feedback |
| Fiber FeedbackEstimated fiber consumption from menu records of weight loss facility. | Behavioural | Delayed Feedback, Rapid Feedback |
Primary outcome
Change in nutrient intake, as estimated from menu selections
Time frame: Baseline, Week 2, and Week 3
Nutrient intake estimated in grams per day, summed over total menu selections.
1 secondary outcome
Change in butyrate concentration
Time frame: Baseline, Week 2, and Week 3
Results and safety
The study was stopped early (reason given: Weight loss center programming suspended due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butyrate Feedback and Fiber Feedback in people with Diet Habit and Feeding Behavior, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Weight loss center programming suspended due to COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nutrient intake, as estimated from menu selections (time frame: Baseline, Week 2, and Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.