Diet, HealthyNCT04067362
Chicory Fiber Effect on Satiety and GI Tolerance
A study testing food containing dietary fiber in people with Diet, Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
The investigators are comparing 2 fiber treatments to a fiber free treatment for acute satiety and GI response. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- food containing dietary fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no food allergies; healthy; willing to consume breakfast in laboratory setting; usual low fiber diet;
Who cannot join
- smokers, taking dietary supplements containing fiber
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Official title: The Effects of 2 Inulin Sources on Satiety and Gastrointestinal Tolerance
The investigators are comparing 2 fiber treatments to a fiber free treatment for acute satiety and GI response.
Read the detailed description
The investigators are measuring satiety and GI response after subjects consume 3 acute breakfast meals: 1. fiber-free control; 2. chicory root flour containing inulin; 3. inulin fiber supplement. After breakfast, subjects will complete subjective satiety instruments and describe any GI symptoms.
- Conditions
- Diet, Healthy
- Being tested
- food containing dietary fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food containing dietary fiberOther
commercially available chicory root flour and chicory root fiber
| Study group | Role | What they receive |
|---|---|---|
| no fiber | Placebo comparator | Breakfast with hot chocolate with no fiber Receives: Other: food containing dietary fiber |
| chicory root flour | Experimental | Breakfast with hot chocolate with chicory root flour Receives: Other: food containing dietary fiber |
| chicory root fiber supplement | Experimental | Breakfast with hot chocolate with chicory root fiber supplement Receives: Other: food containing dietary fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
satiety
subjective instrument to assess how full you feel
Measured: 2 hours
Secondary outcomes (1)
Gastrointestinal response
subjective description of any GI symptoms
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067362
- Sponsor's protocol ID
- STUDY000179126
- Status last verified
- Oct 2020
- First submitted
- 21 Aug 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 2 Inulin Sources on Satiety and Gastrointestinal Tolerance
- ClinicalTrials.gov ID
- NCT04067362
- Acronym / sponsor ID
- STUDY000179126
- Conditions
- Diet, Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 26 Aug 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 investigators are comparing 2 fiber treatments to a fiber free treatment for acute satiety and GI response.
Detailed description
The investigators are measuring satiety and GI response after subjects consume 3 acute breakfast meals: 1. fiber-free control; 2. chicory root flour containing inulin; 3. inulin fiber supplement. After breakfast, subjects will complete subjective satiety instruments and describe any GI symptoms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no fiber | Placebo comparator | Other: food containing dietary fiberBreakfast with hot chocolate with no fiber |
| chicory root flour | Experimental | Other: food containing dietary fiberBreakfast with hot chocolate with chicory root flour |
| chicory root fiber supplement | Experimental | Other: food containing dietary fiberBreakfast with hot chocolate with chicory root fiber supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- no food allergies; healthy; willing to consume breakfast in laboratory setting; usual low fiber diet;
Key exclusion criteria (2 listed)
- smokers, taking dietary supplements containing fiber
- -
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 |
|---|---|---|
| food containing dietary fibercommercially available chicory root flour and chicory root fiber | Other | chicory root fiber supplement, chicory root flour, no fiber |
Primary outcome
satiety
Time frame: 2 hours
subjective instrument to assess how full you feel
1 secondary outcome
Gastrointestinal response
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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 food containing dietary fiber in people with Diet, Healthy, run by University of Minnesota 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 1 inclusion and 2 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 8 Oct 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. Some participants in this study may receive a placebo. 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: COVID-19). 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?
satiety (time frame: 2 hours). 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 8 Oct 2020.