Clinical trial NCT03683654: Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study
Official title: Mining the Urinary and Serum Metabolome for Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Exposure
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: Centre for Research in Epidemiology and Population Health (CESP)
name: Gustave Roussy, Cancer Campus, Grand Paris
name: German Cancer Research Center
name: German Institute of Human Nutrition
name: Hellenic Health Foundation
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Cancer Prevention and Research Institute, Italy
name: Federico II University
name: Center for Cancer Prevention (CPO)
name: Azienda Sanitaria Provinciale Ragusa
First posted: 2018-09-25
Enrollment: 494
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolite concentrations in plasma and urine
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.