Intestinal HealthNCT04570137
Fiber Fermentation Study
A study testing Dietary fiber supplementation in people with Intestinal Health, run by University of Hohenheim at 1 site in Germany.
Trial summary
The aim of the study is to better understand the interplay between the intake of dietary fiber and intestinal bacteria, their metabolic activity and the effect on the intestinal barrier. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Health
- What is being tested?
- Dietary fiber supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jul 2020to 1 Oct 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
- 18 to 65 years
- signed written informed consent
- willingness not to change the dietary pattern in the course of the study
Who cannot join
- BMI below 18 or above 30
- acute or chronic gastrointestinal symptoms
- neoplastic diseases
- very strict diets, including raw foodists and frutarians
- regular smoking (more than one box per day)
- intake of antibiotics, immunosuppressants, or any intestinal therapeutics three months prior to study begin
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- supplementation of fibers three months prior to study begin
- simultaneous participation in another clinical study
- pregnancy / breastfeeding
- relevant violations of the study protocol
- intolerance to the fiber supplements (including wheat, oat, chicory)
- occurrence of relevant diseases (individual decision by study physicians)
- revocation of consent
- placement in a clinic or similar facility based on an official or court order
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, 70599
About this study
Official title: Effects Dietary Fiber From Grains or Fruits and Vegetables on the Intestinal Production of Short-chain Fatty Acids
The aim of the study is to better understand the interplay between the intake of dietary fiber and intestinal bacteria, their metabolic activity and the effect on the intestinal barrier.
The effect of two different dietary fiber supplements is tested (arabinoxylan \& ß-glucan versus inulin \& fructooligosaccharides) in a randomized crossover intervention trial including healthy volunteers.
- Conditions
- Intestinal Health
- Being tested
- Dietary fiber supplementation
- Keywords
- Gastroenterology, Gut microbiome, Gut barrier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fiber supplementationDietary supplement
- 16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan)
- 16g/day: mix of 50% inulin and 50% oligofructose from chicory
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This arm received the arabinoxylan/ß-glucan mix first. Receives: Dietary Supplement: Dietary fiber supplementation |
| 2 | Experimental | This arm received the inulin/oligofructose mix first. Receives: Dietary Supplement: Dietary fiber supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-chain fatty acids (SCFAs)
SCFAs in native fecal samples
Measured: Will be measured in approx. 4 weeks after study completion.
Secondary outcomes (2)
Gut microbiome composition
16S NGS sequencing
Measured: Will be measured in approx. 6-8 weeks after study completion.
Gut barrier integrity
Lipopolysaccharide-binding protein (plasma) and zonulin (feces)
Measured: Will be measured in approx. 4 weeks after study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start6 Jul 2020
- Primary completion30 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal HealthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-armed crossover trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan C. Bischoff, MD, Professor, University of Hohenheim
- Investigators
- Stephan C Bischoff, Prof., MD, Principal investigator, University of Hohenheim, Institute of Nutritional Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570137
- Sponsor's protocol ID
- FiberStudy
- Status last verified
- Jan 2021
- First submitted
- 15 Sep 2020
- Last updated
- 8 Jan 2021
- 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 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Dietary Fiber From Grains or Fruits and Vegetables on the Intestinal Production of Short-chain Fatty Acids
- ClinicalTrials.gov ID
- NCT04570137
- Acronym / sponsor ID
- FiberStudy
- Conditions
- Intestinal Health
- Keywords
- Gastroenterology, Gut microbiome, Gut barrier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 30 Sep 2020 (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 aim of the study is to better understand the interplay between the intake of dietary fiber and intestinal bacteria, their metabolic activity and the effect on the intestinal barrier.
The effect of two different dietary fiber supplements is tested (arabinoxylan \& ß-glucan versus inulin \& fructooligosaccharides) in a randomized crossover intervention trial including healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-armed crossover trial
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Dietary fiber supplementationThis arm received the arabinoxylan/ß-glucan mix first. |
| 2 | Experimental | Dietary Supplement: Dietary fiber supplementationThis arm received the inulin/oligofructose mix first. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years
- signed written informed consent
- willingness not to change the dietary pattern in the course of the study
Key exclusion criteria (14 listed)
- BMI below 18 or above 30
- acute or chronic gastrointestinal symptoms
- neoplastic diseases
- very strict diets, including raw foodists and frutarians
- regular smoking (more than one box per day)
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 |
|---|---|---|
| Dietary fiber supplementation1. 16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan) 2. 16g/day: mix of 50% inulin and 50% oligofructose from chicory | Dietary supplement | 1, 2 |
Primary outcome
Short-chain fatty acids (SCFAs)
Time frame: Will be measured in approx. 4 weeks after study completion.
SCFAs in native fecal samples
2 secondary outcomes
Gut microbiome composition
Time frame: Will be measured in approx. 6-8 weeks after study completion.
Gut barrier integrity
Time frame: Will be measured in approx. 4 weeks after study completion.
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 8 Jan 2021.
- 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.
Stephan C Bischoff, Prof., MD principal investigator
University of Hohenheim, Institute of Nutritional Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary fiber supplementation in people with Intestinal Health, run by University of Hohenheim at 1 site in Germany.
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 14 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 8 Jan 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 Germany. 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 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?
Short-chain fatty acids (SCFAs) (time frame: Will be measured in approx. 4 weeks after study completion.). 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 Jan 2021.