Skip to main content
OpenTrials
Completed

NCT Number: NCT03683654

Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study

This proposal aims at identifying new biomarkers of dietary exposure using metabolomic approaches. This project is based on the European Prospective Investigation on Cancer and Nutrition (EPIC) Calibration Study and more particularly upon a subset of 494 men and women from 4 European countries (Germany, Greece, Italy and France). Urine and blood samples are analyzed by untargeted metabolomics.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dietary Exposure

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

Subjects participating in the study are characterized by the availability of one 24-hr urine sample, blood serum, 24-hr dietary recall (24HDR) and food frequency questionnaire (FFQ) data.

The main objectives of the proposal are:

  • To collect a set of high-quality metabolomic data containing rich information on the food-derived metabolome.
  • To mine this data in different Metabolome-Wide Association Studies in order to identify food-derived metabolites discriminating consumers and non-consumers of various foods, nutrients and dietary patterns.
  • To identify the food-derived metabolites characteristic of the consumption of the different foods/nutrients and dietary patterns.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 30-70
  • Healthy
  • Residing within Europe.
  • Have donated one 24-hr urine sample, blood serum.
  • Have filled one 24-hr dietary recall (24HDR) and food frequency questionnaire (FFQ).

Exclusion criteria

  • 24-hr urine sample and 24-hr dietary recall not collected on a same day.
  • Incomplete collection of 24-hr urine sample.

Treatment and study plan

Identify Biomarkers of Dietary Intake in Healthy Subjects

Other

Observational study. No intervention.

Primary outcomes

  1. Metabolite concentrations in plasma and urine

    Time frame: 1 day

    Food-derived Metabolite concentrations in plasma and urine are measured by high resolution mass spectrometry coupled to ultrahigh performance chromatography.

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Collaborators

  • Azienda Sanitaria Provinciale Ragusa
  • Cancer Prevention and Research Institute, Italy
  • Center for Cancer Prevention (CPO)
  • Centre for Research in Epidemiology and Population Health (CESP)
  • Federico II University
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  • German Cancer Research Center
  • German Institute of Human Nutrition
  • Gustave Roussy, Cancer Campus, Grand Paris
  • Hellenic Health Foundation
  • Imperial College London

Registry information

Official study title

Mining the Urinary and Serum Metabolome for Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2018
Registry last updated
Oct 10, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.