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Biomarkers of Processed Meat Intake

Intervention Study to Identify Biomarkers of Processed Meat Intake

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03354130
Enrollment
12
Registered
2017-11-27
Start date
2017-11-21
Completion date
2018-08-30
Last updated
2018-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers of Processed Meat Intake in Healthy Subjects

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.

Interventions

OTHERProcessed meat dietary intervention

Randomized cross-over dietary intervention with 5 different diets

Sponsors

International Agency for Research on Cancer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Data analyst will know the foods consumed before samples were taken

Intervention model description

Volunteers consume five different diets in a randomized cross-over dietary intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI 18-30 * Healthy

Exclusion criteria

* Vegetarians * Smokers

Design outcomes

Primary

MeasureTime frameDescription
Plasma biomarkers of meat intakeAfter approx. 60 h of dietary interventionPlasma samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
Urinary biomarkers of meat intakeAfter approx. 48 h of dietary interventionUrine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake

Secondary

MeasureTime frameDescription
Biomarkers of meat intake in spot urine2 hours after the first dinner of each intervention periodSpot urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026