HealthyPhase 1/2NCT02796989
The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects
A Phase 1/2 study testing Wheat bran in people with Healthy and Obese, run by KU Leuven at 1 site in Belgium.
Trial summary
During this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Wheat bran
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2016to Dec 2017
- Phase
- Phase 1/2
- 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
- Aged between 18 and 65 years old
- BMI between 18 and 25 kg/m² OR higher than 30 kg/m²
- Regular diet
- Not dieting
Who cannot join
- Use of antibiotics in the month preceding the study
- Diabetes Type 1 or 2
- Abdominal surgery (except from appendectomy)
- Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
- Use of pre- or probiotic supplements in the month preceding the study
- Chronic gastrointestinal diseases, such as inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel disease…
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- Pregnancy or lactation
- Blood donation in the last 3 months
- Abnormal Hb-level (Standard range between 14 and 18 g/dL for men and between 12 and 16 g/dL for women)
- Participation in clinical studies involving radiation exposure in the past year
Trial locations and contacts
1 site in 1 country.
About this study
During this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.
- Being tested
- Wheat bran, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat branDietary supplement
20 g each day
PlaceboDietary supplement
20 g each day
| Study group | Role | What they receive |
|---|---|---|
| Healthy - Wheat Bran | Active comparator | Wheat bran 20 g each day Receives: Dietary Supplement: Wheat bran |
| Healthy - Placebo | Placebo comparator | Placebo 20 g each day Receives: Dietary Supplement: Placebo |
| Obese - Wheat bran | Active comparator | Wheat bran 20 g each day Receives: Dietary Supplement: Wheat bran |
| Obese - Placebo | Placebo comparator | Placebo 20 g each day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo
Measured: 1 month
Secondary outcomes (9)
Changes in glucose levels (mg/dL)
Measured: 1 month
Changes in insulin levels (pmol/L)
Measured: 1 month
Changes in cholesterol levels (mg/dL)
Measured: 1 month
Changes in free fatty acids levels (mmol/L)
Measured: 1 month
Changes in triglyceride levels (mg/dL)
Measured: 1 month
Gut permeability using 51-Cr-EDTA
Measured: 1 month
Total gastrointestinal transit time
Measured: 1 month
Changes in gut microbiota before and after the intervention using 16S rRNA sequencing
Measured: 1 month
Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796989
- Sponsor's protocol ID
- s58346
- Status last verified
- Feb 2021
- First submitted
- 27 May 2016
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Modified Wheat Bran on Carbohydrate Fermentation in the Colon in Healthy and Obese Subjects
- ClinicalTrials.gov ID
- NCT02796989
- Acronym / sponsor ID
- s58346
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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.
During this project the effect of modified wheat bran on colon health and systemic health will be evaluated in a long-term intervention study in healthy and obese subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy - Wheat Bran | Active comparator | Dietary Supplement: Wheat branWheat bran 20 g each day |
| Healthy - Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 20 g each day |
| Obese - Wheat bran | Active comparator | Dietary Supplement: Wheat branWheat bran 20 g each day |
| Obese - Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 20 g each day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 65 years old
- BMI between 18 and 25 kg/m² OR higher than 30 kg/m²
- Regular diet
- Not dieting
Key exclusion criteria (10 listed)
- Use of antibiotics in the month preceding the study
- Diabetes Type 1 or 2
- Abdominal surgery (except from appendectomy)
- Use of medication that affects the gastrointestinal tract during the last 2 weeks prior to the study including spasmolytics, anti-diarrhoea medication, anti-constipation medication
- Use of pre- or probiotic supplements in the month preceding the study
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 |
|---|---|---|
| Wheat bran20 g each day | Dietary supplement | Healthy - Wheat Bran, Obese - Wheat bran |
| Placebo20 g each day | Dietary supplement | Healthy - Placebo, Obese - Placebo |
Primary outcome
The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo
Time frame: 1 month
9 secondary outcomes
Changes in glucose levels (mg/dL)
Time frame: 1 month
Changes in insulin levels (pmol/L)
Time frame: 1 month
Changes in cholesterol levels (mg/dL)
Time frame: 1 month
Changes in free fatty acids levels (mmol/L)
Time frame: 1 month
Changes in triglyceride levels (mg/dL)
Time frame: 1 month
Gut permeability using 51-Cr-EDTA
Time frame: 1 month
Total gastrointestinal transit time
Time frame: 1 month
Changes in gut microbiota before and after the intervention using 16S rRNA sequencing
Time frame: 1 month
Changes in metabolite patterns in the feces before and after the intervention using gas chromatography coupled to mass spectrometry
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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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 Phase 1/2 study testing Wheat bran in people with Healthy and Obese, run by KU Leuven at 1 site in Belgium.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 26 Feb 2021. 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 Belgium. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incremental plasma short-chain fatty acid concentrations will be measured using GC-FID after an intervention with wheat bran/placebo (time frame: 1 month). 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 26 Feb 2021.