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

Dietary Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683654
• Other study ID #: PP201204-12
• Status: Completed
• Start date: April 26, 2012
• Est. completion date: February 23, 2013

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: February 23, 2013
• Est. primary completion date: February 23, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Exposure

Intervention

Other:
• Identify Biomarkers of Dietary Intake in Healthy Subjects
Observational study. No intervention.

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor

Collaborator

International Agency for Research on Cancer

Azienda Sanitaria Provinciale Ragusa, Italy, Cancer Prevention and Research Institute, Italy, Center for Cancer Prevention (CPO), Centre for Research in Epidemiology and Population Health (CESP), France, 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

References & Publications (3)

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, Kühn T, Boeing H, Trichopoulou A, Lagiou P, Trichopoulos D, Palli D, Grioni S, Tumino R, Vineis P, Matt — View Citation

Riboli E, Hunt KJ, Slimani N, Ferrari P, Norat T, Fahey M, Charrondière UR, Hémon B, Casagrande C, Vignat J, Overvad K, Tjønneland A, Clavel-Chapelon F, Thiébaut A, Wahrendorf J, Boeing H, Trichopoulos D, Trichopoulou A, Vineis P, Palli D, Bueno-De-Mesquita HB, Peeters PH, Lund E, Engeset D, González 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. — View Citation

Slimani N, Ferrari P, Ocké M, Welch A, Boeing H, Liere M, Pala V, Amiano P, Lagiou A, Mattisson I, Stripp C, Engeset D, Charrondière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Website of the EPIC cohort study