HealthyNCT02378376
In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon
A study testing Arabinoxylan oligosaccharides and Dietary fiber enriched bran in people with Healthy, run by KU Leuven.
Trial summary
During this project the amount of SCFA produced in the colon after consumption of 2 different 13C-labelled wheat fiber fractions will be quantified. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Arabinoxylan oligosaccharides and Dietary fiber enriched bran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Feb 2015
- 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
- Regular diet with 3 meals a day (minimal 5 times a week)
- BMI between 18.5 and 27 kg/m2
Who cannot join
- Calorie restricted diet or other special diet during the study or during the last month prior to the study
- Antibiotics in the month prior to the study
- Former surgeries on the gastrointestinal tract, with the exception of an appendectomy
- use of the following types of medications with effects on the gastrointestinal tract during the last 2 weeks prior to the study (spasmolytica, anti-diarrhea, anti-constipation, probiotics)
- Chronic disease of the gastrointestinal tract such as Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation, chronic frequent diarrhea, clinically relevant lactose intolerance
- Pregnancy, pregnancy desire or breastfeeding
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- Diabetes (type 1 and 2)
- Blood donation in the past 3 months prior to the study
- Abnormal hemoglobin (Hb) levels in blood, men must have a Hb level between 14.0 and 18.0 g / dL and women between 12.0 and 16.0 g / dL
- Participation in studies in the past year in which radiation was used.
About this study
Official title: In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon After Consumption of Different Cereal Fractions.
During this project the amount of SCFA produced in the colon after consumption of 2 different 13C-labelled wheat fiber fractions will be quantified.
- Conditions
- Healthy
- Being tested
- Arabinoxylan oligosaccharides, Dietary fiber enriched bran
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabinoxylan oligosaccharidesDietary supplement
Dietary fiber enriched branDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Wheat derived fiber fraction 1 | Experimental | Arabinoxylan oligosaccharides Receives: Dietary Supplement: Arabinoxylan oligosaccharides |
| Wheat derived fiber fraction 2 | Experimental | Dietary fiber enriched bran Receives: Dietary Supplement: Dietary fiber enriched bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of acetate, propionate and butyrate production in the colon after consumption of each wheat derived fiber fraction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionFeb 2015
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 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
- NCT02378376
- Sponsor's protocol ID
- s55383
- Status last verified
- Feb 2015
- First submitted
- 27 Feb 2015
- Last updated
- 4 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon After Consumption of Different Cereal Fractions.
- ClinicalTrials.gov ID
- NCT02378376
- Acronym / sponsor ID
- s55383
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Mar 2015 (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 amount of SCFA produced in the colon after consumption of 2 different 13C-labelled wheat fiber fractions will be quantified.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheat derived fiber fraction 1 | Experimental | Dietary Supplement: Arabinoxylan oligosaccharidesArabinoxylan oligosaccharides |
| Wheat derived fiber fraction 2 | Experimental | Dietary Supplement: Dietary fiber enriched branDietary fiber enriched bran |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Regular diet with 3 meals a day (minimal 5 times a week)
- BMI between 18.5 and 27 kg/m2
Key exclusion criteria (10 listed)
- Calorie restricted diet or other special diet during the study or during the last month prior to the study
- Antibiotics in the month prior to the study
- Former surgeries on the gastrointestinal tract, with the exception of an appendectomy
- use of the following types of medications with effects on the gastrointestinal tract during the last 2 weeks prior to the study (spasmolytica, anti-diarrhea, anti-constipation, probiotics)
- Chronic disease of the gastrointestinal tract such as Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation, chronic frequent diarrhea, clinically relevant lactose intolerance
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 |
|---|---|---|
| Arabinoxylan oligosaccharides | Dietary supplement | Wheat derived fiber fraction 1 |
| Dietary fiber enriched bran | Dietary supplement | Wheat derived fiber fraction 2 |
Primary outcome
Quantification of acetate, propionate and butyrate production in the colon after consumption of each wheat derived fiber fraction
Time frame: 2 years
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 4 Mar 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Arabinoxylan oligosaccharides and Dietary fiber enriched bran in people with Healthy, run by KU Leuven.
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 2 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 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Quantification of acetate, propionate and butyrate production in the colon after consumption of each wheat derived fiber fraction (time frame: 2 years). 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 4 Mar 2015.