NCT03683654

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
494

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2013

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

September 21, 2018

Last Update Submit

October 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Observational study. No intervention.

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 12639222BACKGROUND
  • 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.

    PMID: 11114689BACKGROUND
  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

24-hour urine samples Plasma samples

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 25, 2018

Study Start

April 26, 2012

Primary Completion

February 23, 2013

Study Completion

February 23, 2013

Last Updated

October 10, 2018

Record last verified: 2018-10