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临床试验/NCT04235348
NCT04235348已完成不适用

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.

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
161
试验地点
1
主要终点
Colonic mucus thickness

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Colonic mucus thickness

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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