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

April 24, 2020 updated by: University of Southern Denmark

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

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Denmark
      • Aabenraa, South Denmark, Denmark, 6200
        • Hospital og Southern Jutland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
BELIEVE
Consists of subjects referred to a colonoscopy between June 1, 2017, and December 1, 2019, in the hospital of Southern Denmark

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
November 30,2019

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muc-2 gene expression
Time Frame: 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
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
These markers will be evaluated in relation to red meat and whole-grain intake
January 1-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mohamad Jawhara, M.D., The University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

January 28, 2020

Study Completion (ACTUAL)

February 28, 2020

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

January 16, 2020

First Posted (ACTUAL)

January 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

December 1, 2019

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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