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

Mining the Urinary and Serum Metabolome for 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.

Study Overview

• Status: Completed
• Conditions: Dietary Exposure
• Intervention / Treatment: Other: Identify Biomarkers of Dietary Intake in Healthy Subjects

Detailed Description

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:

1. To collect a set of high-quality metabolomic data containing rich information on the food-derived metabolome.
2. 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.
3. To identify the food-derived metabolites characteristic of the consumption of the different foods/nutrients and dietary patterns.

• Study Type: Observational
• Enrollment (Actual): 494

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

494 men and women from 4 European countries (Germany, Greece, Italy and France) selected from the EPIC Calibration study. Different settings by centre; mostly general population with some exceptions: women of a health insurance company for teachers and school workers (France), women attending breast cancer screening (Florence-Italy), mainly blood donors (most centers in Italy) and a cohort consisting predominantly of vegetarians (the 'health-conscious' group in Oxford, UK).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolite concentrations in plasma and urine	Food-derived Metabolite concentrations in plasma and urine are measured by high resolution mass spectrometry coupled to ultrahigh performance chromatography.	1 day

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Riboli E, Hunt KJ, Slimani N, Ferrari P, Norat T, Fahey M, Charrondiere UR, Hemon B, Casagrande C, Vignat J, Overvad K, Tjonneland A, Clavel-Chapelon F, Thiebaut A, Wahrendorf J, Boeing H, Trichopoulos D, Trichopoulou A, Vineis P, Palli D, Bueno-De-Mesquita HB, Peeters PH, Lund E, Engeset D, Gonzalez CA, Barricarte A, Berglund G, Hallmans G, Day NE, Key TJ, Kaaks R, Saracci R. European Prospective Investigation into Cancer and Nutrition (EPIC): study populations and data collection. Public Health Nutr. 2002 Dec;5(6B):1113-24. doi: 10.1079/PHN2002394.
• Slimani N, Ferrari P, Ocke M, Welch A, Boeing H, Liere M, Pala V, Amiano P, Lagiou A, Mattisson I, Stripp C, Engeset D, Charrondiere R, Buzzard M, Staveren W, Riboli E. Standardization of the 24-hour diet recall calibration method used in the european prospective investigation into cancer and nutrition (EPIC): general concepts and preliminary results. Eur J Clin Nutr. 2000 Dec;54(12):900-17. doi: 10.1038/sj.ejcn.1601107.
• Edmands WM, Ferrari P, Rothwell JA, Rinaldi S, Slimani N, Barupal DK, Biessy C, Jenab M, Clavel-Chapelon F, Fagherazzi G, Boutron-Ruault MC, Katzke VA, Kuhn T, Boeing H, Trichopoulou A, Lagiou P, Trichopoulos D, Palli D, Grioni S, Tumino R, Vineis P, Mattiello A, Romieu I, Scalbert A. Polyphenol metabolome in human urine and its association with intake of polyphenol-rich foods across European countries. Am J Clin Nutr. 2015 Oct;102(4):905-13. doi: 10.3945/ajcn.114.101881. Epub 2015 Aug 12.

Helpful Links

• Website of the EPIC cohort study

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2012
• Primary Completion (ACTUAL): February 23, 2013
• Study Completion (ACTUAL): February 23, 2013

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (ACTUAL): September 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PP201204-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No