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临床试验/NCT03354130
NCT03354130已完成不适用

Intervention Study to Identify Biomarkers of Processed Meat Intake

International Agency for Research on Cancer1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Urinary biomarkers of meat intake

研究概览

简要总结

The intake of processed meat products has been linked to several adverse health outcomes. However, estimation of their intake proves difficult. This study aims at identifying biomarkers of intake for processed meat products in blood and urine. For this, participants of a randomized cross-over dietary intervention will consume highly controlled diets containing non-processed pork, different processed meat products or no meat. Urine and plasma will be collected and analysed to identify sets of metabolites that are specific for the intake of the processed meat products.

详细描述

The intake of processed meat has been linked to several adverse health outcomes such as cancer. However, little is known about the respective effects of the single products in this diverse group.

Most epidemiological studies rely on self-reported questionnaires to assess the intake of different foods. Even though this method is relatively easy to perform, it is prone to errors such as memory biases of subjects or difficulties in estimating portion size. The use of food specific biomarkers may overcome this limitation by offering an objective quantification of dietary exposure. No biomarkers for the consumption of processed meat products have been established yet.

Twelve human healthy adults will participate in a randomized cross-over dietary intervention study and will consume three different processed meat products, fresh meat or no meat, each during 3 successive days followed by a 10-day washout period. The metabolite profile in urine and plasma samples will be analysed to find metabolites that are specific for the intake of the processed meat products.

The identification of these biomarkers in blood and urine will allow a more precise estimation of intake of different processed meat products. This will enable a more robust estimation of the risk linked to the intake of processed meat products.

研究设计

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

盲法说明

Data analyst will know the foods consumed before samples were taken

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 18-30

排除标准

  • Vegetarians

研究组 & 干预措施

Tofu control

Active Comparator

Volunteers will consume a vegetarian diet containing tofu during 3 days for 5 meals in total

干预措施: Processed meat dietary intervention (Other)

Non-processed pork diet

Experimental

Volunteers will consume a diet containing non-processed pork during 3 days for 5 meals in total

干预措施: Processed meat dietary intervention (Other)

Bacon diet

Experimental

Volunteers will consume a diet containing bacon during 3 days for 5 meals in total

干预措施: Processed meat dietary intervention (Other)

Sausage diet

Experimental

Volunteers will consume a diet containing sausage during 3 days for 5 meals in total

干预措施: Processed meat dietary intervention (Other)

Dry-cured sausage diet

Experimental

Volunteers will consume a diet containing dry-cured sausage during 3 days for 5 meals in total

干预措施: Processed meat dietary intervention (Other)

结局指标

主要结局

Urinary biomarkers of meat intake

时间窗: After approx. 48 h of dietary intervention

Urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake

Plasma biomarkers of meat intake

时间窗: After approx. 60 h of dietary intervention

Plasma samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake

次要结局

  • Biomarkers of meat intake in spot urine(Approx. 12 h after the first dinner of each intervention period)

研究者

发起方
International Agency for Research on Cancer
申办方类型
Other
责任方
Sponsor

研究点 (1)

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