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临床试验/NCT06547190
NCT06547190已完成不适用

Study on Treating by Eating: Role of AGEs on Mucosal Barrier and Microbiome.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年2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
20
试验地点
1
主要终点
Gut microbial composition

研究概览

简要总结

This is an exploratory study aimed at healthy volunteers to investigate the impact of differential cooking methods on global and gut inflammation, intestinal permeability, and the gut microbiota. The investigators hypothesize that a short dietary intervention of baking and grilling of food for 2 weeks as opposed to steaming and boiling of food for 2 weeks will result in measurable differences in blood, stool and urine samples that guide towards gut and overall health and disease. All food will be provided, together with detailed cooking instructions. Food logs including photographs will be used to check whether participants complied with the study.

The investigators aim to better understand the role of cooking methods in human health, so that this can be implemented in preventive strategies and dietary treatments for specific patient groups.

详细描述

This is a pilot project aimed at healthy volunteers to investigate the impact of differential cooking methods on systemic and intestinal inflammation, permeability, and the gut microbiota, using a randomised cross-over design. The investigators hypothesize that a short dietary intervention of baking and grilling of food for 2 weeks (high-Advanced Glycation End Products (AGEs) diet) as opposed to steaming and boiling of food for 2 weeks (low-AGEs diet) will result in measurable differences in inflammatory, cardiometabolic and microbial markers in blood and stool as well as changes in intestinal permeability through their effect on dietary AGEs. All food will be provided, together with detailed cooking instructions. Food logs including photographs will be used to assess and check adherence to the intervention.

The investigators aim to better understand the role of cooking methods and thermal treatments in human health, so that this can be implemented in preventive strategies and dietary treatments for specific patient groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Overall healthy
  • Adhering to an omnivorous diet
  • Body Mass Index (BMI) between 18.5 - 30 kg/m2
  • Able to provide consent.

排除标准

  • Participants with chronic illnesses including diabetes mellitus, cardiovascular disease, or cancer; eating disorders, irritable bowel syndrome; inflammatory bowel diseases, and previous bowel surgery (except for appendectomy).
  • Current smoking
  • Participants taking nonsteroidal anti-inflammatory drugs (NSAIDS), proton pump inhibitors, antacids, or laxatives one month before enrollment or antibiotics, prebiotics or probiotics six months before the start of the trial.
  • Pregnancy of lactation

结局指标

主要结局

Gut microbial composition

时间窗: 2 weeks

Measurement of the composition of the gut microbiota using 16s rRNA sequencing of stool samples.

Intestinal transcellular permeability

时间窗: 2 weeks

Measurement of transcellular intestinal permeability using lipopolysaccharide binding protein in blood samples

Intestinal inflammation

时间窗: 2 weeks

Measurement of faecal calprotectin through stool samples (in mg/kg)

Systemic lipid profile

时间窗: 2 weeks

Total, LDL- and HDL-cholesterol values in blood samples (in mg/dl)

Weight changes

时间窗: 2 weeks

weight (in kg)

Gut microbial metabolism

时间窗: 2 weeks

Measurement of short chain fatty acids including acetic acid, propionic acid and butyric acid through stool samples (in mg/100g stool)

Intestinal paracellular permeability

时间窗: 2 weeks

Measurement of paracellular intestinal permeability using the lacultulose mannitol test using urine samples

Systemic cardiometabolic health

时间窗: 2 weeks

serum cardiometabolic parameters through OLINK cardiometabolic panel (measurement of 92 proteins in blood)

Handgrip strength changes

时间窗: 2 weeks

Handgrip strength (in kg)

Systemic inflammation

时间窗: 2 weeks

serum inflammation through OLINK inflammatory panel (measurement of 92 proteins in blood)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JoaoSabino

Prof. dr. João Sabino

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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