The Impact of Red Meat and Whole-grains Intake on the Colonic Mucosal Barrier

Completed

• Conditions: Mucus Colitis; Dietary Exposure; Inflammation, Colon

• Registration Number: NCT04235348
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-21
• Primary Completion: 2020-01-28
• Study Completion: 2020-02-28
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colonic mucus thickness	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

Secondary Outcome Measures

Name	Time	Method
Muc-2 gene expression	December 10, 2019	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
Inflammatory markers in blood (IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa)	January 1-2020	These markers will be evaluated in relation to red meat and whole-grain intake

Trial Locations

Locations (1)

Hospital og Southern Jutland; 🇩🇰 Aabenraa, South Denmark, Denmark