Skip to main content
OpenTrials
Completed

NCT Number: NCT03354130

Biomarkers of Processed Meat Intake

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Agency for Research on Cancer

Lyon, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 18-30
  • Healthy

Exclusion criteria

  • Vegetarians
  • Smokers

Treatment and study plan

Processed meat dietary intervention

Other

Randomized cross-over dietary intervention with 5 different diets

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Biomarkers of meat intake in spot urine

    Time frame: 2 hours after the first dinner of each intervention period

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

  2. Biomarkers of meat intake in spot urine

    Time frame: Approx. 12 h after the first dinner of each intervention period

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

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Registry information

Official study title

Intervention Study to Identify Biomarkers of Processed Meat Intake

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2017
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.