- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235348
The Impact of Red Meat and Whole-grains Intake on the Colonic Mucosal Barrier
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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South Denmark
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Aabenraa, South Denmark, Denmark, 6200
- Hospital og Southern Jutland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of active cancer
- A recent colonoscopy (less than 3 months ago )
- Anamnesis of Inflammatory bowel diseases.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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BELIEVE
Consists of subjects referred to a colonoscopy between June 1, 2017, and December 1, 2019, in the hospital of Southern Denmark
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Colonic mucus thickness
Time Frame: November 30,2019
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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
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November 30,2019
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muc-2 gene expression
Time Frame: December 10, 2019
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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
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December 10, 2019
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Inflammatory markers in blood (IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa)
Time Frame: January 1-2020
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These markers will be evaluated in relation to red meat and whole-grain intake
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January 1-2020
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mohamad Jawhara, M.D., The University of Southern Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ColonicMucus
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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