Clinical trial NCT04235348: The Impact of Red Meat and Whole-grains Intake on the Colonic Mucosal Barrier
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucus Colitis
Inflammation, Colon
Dietary Exposure
Keywords: Colonic mucus
Mucosal barrier
Red meat
Whole grain
Dietary fibers
Inflammation
Muc-2
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: Horizon 2020 - European Commission
name: Hospital of Southern Jutland
name: Knud and Edith Eriksens fond
First posted: 2020-01-21
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred to a colonoscopy in the Hospital of Southern Denmark, and who met the eligibility criteria of this study were included.

Brief 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

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:

1. High consumption of red meat is associated with a thinner colonic mucus layer;
2. High consumption of whole-grain fibres is associated with a thicker colonic mucus layer;
3. Mucin-2 gene expression is different between patients with high red meat consumption vs low red meat consumption;
4. Mucin-2 gene expression is different between patients with high whole-grain consumption vs low whole-grain intake;
5. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Colonic mucus thickness
timeFrame: November 30,2019
Secondary outcomes:
measure: Muc-2 gene expression
timeFrame: December 10, 2019
measure: Inflammatory markers in blood (IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa)
timeFrame: January 1-2020
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Hospital og Southern Jutland
state: South Denmark
Study officials:
affiliation: The University of Southern Denmark
name: Mohamad Jawhara, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.