The Impact of Red Meat and Whole-grains Intake on the Col... | NCT04235348

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

NCT04235348

Sponsor

University of Southern Denmark

Status

Completed

Last Update Posted

Apr 28, 2020Actual

Enrollment

161Actual

Phase

Not provided

Conditions

Mucus Colitis
Inflammation, Colon
Dietary Exposure

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jan 28, 2020Actual

Completion Date

Feb 28, 2020Actual

First Submitted Date

Dec 10, 2019

First Submission Date that Met QC Criteria

Jan 16, 2020

First Posted Date

Jan 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2020

Last Update Posted Date

Apr 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University of Southern DenmarkOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

161Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BELIEVE		Consists of subjects referred to a colonoscopy between June 1, 2017, and December 1, 2019, in the hospital of Southern Denmark

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Inflammatory markers in blood (IL-1beta, IL-4, IL-6, IL-10, Hs-CRP, and TNF-alfa)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects referred to a colonoscopy in the Hospital of Southern Denmark, and who met the eligibility criteria of this study were included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohamad Jawhara, M.D.	The University of Southern Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital og Southern Jutland		Aabenraa	Region Syddanmark	6200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32545531	Derived	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.

ID	Term
D043183	Irritable Bowel Syndrome
D007249	Inflammation

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases