Biomarkers of Processed Meat Intake

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intervention Study to Identify Biomarkers of Processed Meat Intake

Conditions
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Biomarkers of Processed Meat Intake in Healthy Subjects

Intervention / Treatment
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* Other: Processed meat dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18-30 Healthy Exclusion Criteria: Vegetarians Smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Volunteers consume five different diets in a randomized cross-over dietary intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tofu control<br>Volunteers will consume a vegetarian diet containing tofu during 3 days for 5 meals in total | Other: Processed meat dietary intervention<br>* Randomized cross-over dietary intervention with 5 different diets<br>|
| Experimental: Non-processed pork diet<br>Volunteers will consume a diet containing non-processed pork during 3 days for 5 meals in total | Other: Processed meat dietary intervention<br>* Randomized cross-over dietary intervention with 5 different diets<br>|
| Experimental: Bacon diet<br>Volunteers will consume a diet containing bacon during 3 days for 5 meals in total | Other: Processed meat dietary intervention<br>* Randomized cross-over dietary intervention with 5 different diets<br>|
| Experimental: Sausage diet<br>Volunteers will consume a diet containing sausage during 3 days for 5 meals in total | Other: Processed meat dietary intervention<br>* Randomized cross-over dietary intervention with 5 different diets<br>|
| Experimental: Dry-cured sausage diet<br>Volunteers will consume a diet containing dry-cured sausage during 3 days for 5 meals in total | Other: Processed meat dietary intervention<br>* Randomized cross-over dietary intervention with 5 different diets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma biomarkers of meat intake | Plasma samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake | After approx. 60 h of dietary intervention | 
| Urinary biomarkers of meat intake | Urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake | After approx. 48 h of dietary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of meat intake in spot urine | Spot urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake | 2 hours after the first dinner of each intervention period | 
| Biomarkers of meat intake in spot urine | Spot urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake | Approx. 12 h after the first dinner of each intervention period |