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

NCT04235348 | Completed DMC

• 1 other identifier: ColonicMucus
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

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

Conditions

Mucus Colitis; Inflammation, Colon; Dietary Exposure

Keywords

Colonic mucus; Mucosal barrier; Red meat; Whole grain; Dietary fibers; Inflammation; Muc-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Muc-2 gene expression

  December 10, 2019

• Inflammatory markers in blood (IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa)

  January 1-2020

Study Arms (1)

BELIEVE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• History of active cancer
• A recent colonoscopy (less than 3 months ago )
• Anamnesis of Inflammatory bowel diseases.

Sponsors & Collaborators

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

Study Sites (1)

Hospital og Southern Jutland

Aabenraa, Region Syddanmark, 6200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32545531 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Fecal samples in DNA- stabilizing medium * Biopsies from the colon sigmoideum immediately frozen in nitrogen liquid * Biopsies from the colon sigmoideum in RNAlater, and frozen under -80 degree celsius * Blood samples * Spot-urine

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamad Jawhara, M.D.

  The University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: January 21, 2020
• Study Start: June 1, 2017
• Primary Completion: January 28, 2020
• Study Completion: February 28, 2020
• Last Updated: April 28, 2020

Record last verified: 2019-12

Locations

DK (1)