Mucus ColitisNCT04235348
The Impact of Red Meat and Whole-grains Intake on the Colonic Mucosal Barrier
An observational study of Mucus Colitis and Inflammation, Colon, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This study evaluates the impact of red meat and whole-grain intake on the colonic mucosal barrier and the dietary impact of these groups on the induced low-grade inflammation Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucus Colitis, Inflammation, Colon, Dietary Exposure
- How many people
- 161 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2017to 28 Feb 2020
- Phase
- Observational
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects referred to a colonoscopy in the Hospital of Southern Denmark, and who met the eligibility criteria of this study were included.
Who may be able to join
- Subjects referred to a colonoscopy in the Hospital of Southern Denmark
- Subjects able to read and understand Danish
- Mentally habile subjects
- Subjects who accept to be a part of the project
Who cannot join
- History of active cancer
- A recent colonoscopy (less than 3 months ago )
- Anamnesis of Inflammatory bowel diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Red Meat and Whole-grains Intake on the Colonic Mucus' Thickness, Colonic MUC-2 Expression Rate and the Inflammatory Markers in the Blood.
This study evaluates the impact of red meat and whole-grain intake on the colonic mucosal barrier and the dietary impact of these groups on the induced low-grade inflammation
Read the detailed description
The mucus layer in the colon is a continuous barrier separating the epithelial cells from faecal enzymes, bacteria, toxic and other components. The colonic mucus layer in patients with Crohn's Disease and Ulcerative Colitis was previously demonstrated to be thinner and more permeable compared to healthy subjects.
The colonic mucus is composed of glycoproteins held together trough unstable disulfide bridges. The digestion of red meat is associated with monosulfide production, which could bind to the disulfide molecules, make more stable trisulfide molecules, and thus destroy the mucus architecture. Moreover, different bacteria were previously linked to red meat intake and were associated with a degradation of the colonic mucus such as akkermansia muciniphila.
From the other side, the fermentation of the undigested fibres, primarily in whole-grains, is associated with the production of short-chain fatty acids, which was related to a local anti-inflammatory effect.
In this study, we hypothesise:
- High consumption of red meat is associated with a thinner colonic mucus layer;
- High consumption of whole-grain fibres is associated with a thicker colonic mucus layer;
- Mucin-2 gene expression is different between patients with high red meat consumption vs low red meat consumption;
- Mucin-2 gene expression is different between patients with high whole-grain consumption vs low whole-grain intake;
- The level of inflammatory markers in blood "IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa is higher in subjects with high red meat and low whole-grain intake.
- Conditions
- Mucus Colitis, Inflammation, Colon, Dietary Exposure
- Keywords
- Colonic mucus, Mucosal barrier, Red meat, Whole grain, Dietary fibers, Inflammation, Muc-2
- Medical subject headings
- Irritable Bowel Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BELIEVE | Consists of subjects referred to a colonoscopy between June 1, 2017, and December 1, 2019, in the hospital of Southern Denmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic mucus thickness
We will evaluate the thickness of the inner mucus layer in 38 biopsies of subjects, at the upper and lower quartiles of red meat and whole-grain consumption
Measured: November 30,2019
Secondary outcomes (2)
Muc-2 gene expression
Using real time PCR, we will examine the association between the expression of mucin 2 gene in relation to red meat and whole grain fiber intake
Measured: December 10, 2019
Inflammatory markers in blood (IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa)
These markers will be evaluated in relation to red meat and whole-grain intake
Measured: January 1-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Jun 2017
- Primary completion28 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mucus ColitisStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, Horizon 2020 - European Commission, Hospital of Southern Jutland, Knud and Edith Eriksens fond
- Responsible party
- Sponsor
- Investigators
- Mohamad Jawhara, M.D., Principal investigator, The University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235348
- Sponsor's protocol ID
- ColonicMucus
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jawhara M, Sorensen SB, Heitmann BL, Halldorsson ThornI, Pedersen AK, Andersen V. The Relation between Red Meat and Whole-Grain Intake and the Colonic Mucosal Barrier: A Cross-Sectional Study. Nutrients. 2020 Jun 12;12(6):1765. doi: 10.3390/nu12061765.
PubMed 32545531
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Red Meat and Whole-grains Intake on the Colonic Mucus' Thickness, Colonic MUC-2 Expression Rate and the Inflammatory Markers in the Blood.
- ClinicalTrials.gov ID
- NCT04235348
- Acronym / sponsor ID
- ColonicMucus
- Conditions
- Mucus Colitis, Inflammation, Colon, Dietary Exposure
- Keywords
- Colonic mucus, Mucosal barrier, Red meat, Whole grain, Dietary fibers, Inflammation, Muc-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, Horizon 2020 - European Commission, Hospital of Southern Jutland, Knud and Edith Eriksens fond
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 21 Jan 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.
This study evaluates the impact of red meat and whole-grain intake on the colonic mucosal barrier and the dietary impact of these groups on the induced low-grade inflammation
Detailed description
The mucus layer in the colon is a continuous barrier separating the epithelial cells from faecal enzymes, bacteria, toxic and other components. The colonic mucus layer in patients with Crohn's Disease and Ulcerative Colitis was previously demonstrated to be thinner and more permeable compared to healthy subjects.
The colonic mucus is composed of glycoproteins held together trough unstable disulfide bridges. The digestion of red meat is associated with monosulfide production, which could bind to the disulfide molecules, make more stable trisulfide molecules, and thus destroy the mucus architecture. Moreover, different bacteria were previously linked to red meat intake and were associated with a degradation of the colonic mucus such as akkermansia muciniphila.
From the other side, the fermentation of the undigested fibres, primarily in whole-grains, is associated with the production of short-chain fatty acids, which was related to a local anti-inflammatory effect.
In this study, we hypothesise:
- High consumption of red meat is associated with a thinner colonic mucus layer;
- High consumption of whole-grain fibres is associated with a thicker colonic mucus layer;
- Mucin-2 gene expression is different between patients with high red meat consumption vs low red meat consumption;
- Mucin-2 gene expression is different between patients with high whole-grain consumption vs low whole-grain intake;
- The level of inflammatory markers in blood "IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa is higher in subjects with high red meat and low whole-grain intake.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BELIEVE | – | –Consists of subjects referred to a colonoscopy between June 1, 2017, and December 1, 2019, in the hospital of Southern Denmark |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred to a colonoscopy in the Hospital of Southern Denmark, and who met the eligibility criteria of this study were included.
Key inclusion criteria (4 listed)
- Subjects referred to a colonoscopy in the Hospital of Southern Denmark
- Subjects able to read and understand Danish
- Mentally habile subjects
- Subjects who accept to be a part of the project
Key exclusion criteria (3 listed)
- History of active cancer
- A recent colonoscopy (less than 3 months ago )
- Anamnesis of Inflammatory bowel diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Colonic mucus thickness
Time frame: November 30,2019
We will evaluate the thickness of the inner mucus layer in 38 biopsies of subjects, at the upper and lower quartiles of red meat and whole-grain consumption
2 secondary outcomes
Muc-2 gene expression
Time frame: December 10, 2019
Inflammatory markers in blood (IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa)
Time frame: January 1-2020
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 28 Apr 2020.
- Derived from this study: PubMed 32545531Jawhara M, Sorensen SB, Heitmann BL, Halldorsson ThornI, Pedersen AK, Andersen V. The Relation between Red Meat and Whole-Grain Intake and the Colonic Mucosal Barrier: A Cross-Sectional Study. Nutrients. 2020 Jun 12;12(6):1765. doi: 10.3390/nu12061765.
- Individual participant dataSharing planned: Undecided
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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.
Mohamad Jawhara, M.D. principal investigator
The University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucus Colitis and Inflammation, Colon, run by University of Southern Denmark at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 28 Apr 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 Denmark. 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?
Colonic mucus thickness (time frame: November 30,2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235348, which also lists 1 linked publication.
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 28 Apr 2020.