Dietary ExposureNCT03683654
Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study
An observational study of Dietary Exposure, run by International Agency for Research on Cancer.
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… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- Identify Biomarkers of Dietary Intake in Healthy Subjects
- How many people
- 494 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2012to 23 Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 24-hr urine sample and 24-hr dietary recall not collected on a same day.
- Incomplete collection of 24-hr urine sample.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Dietary Exposure
- Being tested
- Identify Biomarkers of Dietary Intake in Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identify Biomarkers of Dietary Intake in Healthy SubjectsOther
Observational study. No intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start26 Apr 2012
- Primary completion23 Feb 2013
- Study completion23 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dietary ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Centre for Research in Epidemiology and Population Health (CESP), Gustave Roussy, Cancer Campus, Grand Paris, German Cancer Research Center, German Institute of Human Nutrition, Hellenic Health Foundation, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Cancer Prevention and Research Institute, Italy, Federico II University, Center for Cancer Prevention (CPO), Azienda Sanitaria Provinciale Ragusa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683654
- Sponsor's protocol ID
- PP201204-12
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 12639222Slimani 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.
PubMed 11114689Edmands 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.
PubMed 26269369
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mining the Urinary and Serum Metabolome for Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study
- ClinicalTrials.gov ID
- NCT03683654
- Acronym / sponsor ID
- PP201204-12
- Conditions
- Dietary Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Imperial College London, Centre for Research in Epidemiology and Population Health (CESP), Gustave Roussy, Cancer Campus, Grand Paris, German Cancer Research Center, German Institute of Human Nutrition, Hellenic Health Foundation, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Cancer Prevention and Research Institute, Italy, Federico II University, Center for Cancer Prevention (CPO), Azienda Sanitaria Provinciale Ragusa
- Study start
- 26 Apr 2012 (actual)
- Primary completion
- 23 Feb 2013 (actual)
- Study completion
- 23 Feb 2013 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 24-hr urine sample and 24-hr dietary recall not collected on a same day.
- Incomplete collection of 24-hr urine sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identify Biomarkers of Dietary Intake in Healthy SubjectsObservational study. No intervention. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Background: PubMed 12639222Riboli 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.
- Background: PubMed 11114689Slimani 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.
- Results publication: PubMed 26269369Edmands 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.
- Website of the EPIC cohort studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Exposure, run by International Agency for Research on Cancer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolite concentrations in plasma and urine (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683654, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.