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Completed

NCT Number: NCT04235348

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

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital og Southern Jutland

Aabenraa, Region Syddanmark, 6200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Horizon 2020 - European Commission
  • Hospital of Southern Jutland
  • Knud and Edith Eriksens fond
  • Region of Southern Denmark

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 21, 2020
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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