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

Dietary Exposure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235348
• Other study ID #: ColonicMucus
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: December 2019
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: February 28, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Exposure
• Inflammation
• Inflammation, Colon
• Mucus Colitis

Locations

Country	Name	City	State
Denmark	Hospital og Southern Jutland	Aabenraa	South Denmark

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern Denmark	Horizon 2020 - European Commission, Hospital of Southern Jutland, Knud and Edith Eriksens fond, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	November 30,2019
Secondary	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	December 10, 2019
Secondary	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	January 1-2020