Intervention Study to Identify Biomarkers of Processed Meat Intake
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Urinary biomarkers of meat intake
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
Data analyst will know the foods consumed before samples were taken
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI 18-30
Exclusion Criteria
- •Vegetarians
Arms & Interventions
Tofu control
Volunteers will consume a vegetarian diet containing tofu during 3 days for 5 meals in total
Intervention: Processed meat dietary intervention (Other)
Non-processed pork diet
Volunteers will consume a diet containing non-processed pork during 3 days for 5 meals in total
Intervention: Processed meat dietary intervention (Other)
Bacon diet
Volunteers will consume a diet containing bacon during 3 days for 5 meals in total
Intervention: Processed meat dietary intervention (Other)
Sausage diet
Volunteers will consume a diet containing sausage during 3 days for 5 meals in total
Intervention: Processed meat dietary intervention (Other)
Dry-cured sausage diet
Volunteers will consume a diet containing dry-cured sausage during 3 days for 5 meals in total
Intervention: Processed meat dietary intervention (Other)
Outcomes
Primary Outcomes
Urinary biomarkers of meat intake
Time Frame: 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
Time Frame: After approx. 60 h of dietary intervention
Plasma samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
Secondary Outcomes
- Biomarkers of meat intake in spot urine(Approx. 12 h after the first dinner of each intervention period)