Biomarkers of Processed Meat Intake

Biomarkers of Processed Meat Intake in Healthy Subjects Clinical Trial

Official title:

Intervention Study to Identify Biomarkers of Processed Meat Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354130
• Other study ID #: PP201711-15
• Status: Completed
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: November 2018
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• BMI 18-30

• Healthy

Exclusion Criteria:

• Vegetarians

• Smokers

Related Conditions & MeSH terms

• Biomarkers of Processed Meat Intake in Healthy Subjects

Intervention

Other:
• Processed meat dietary intervention
Randomized cross-over dietary intervention with 5 different diets

Locations

Country	Name	City	State
France	International Agency for Research on Cancer	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
International Agency for Research on Cancer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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