Dietary intakes in polyphenols and risk of cancers in the EPIC cohort

ISRCTN ISRCTN15150764
DOI https://doi.org/10.1186/ISRCTN15150764
Secondary identifying numbers WCRF NL 2012/604
Submission date
10/10/2017
Registration date
12/10/2017
Last edited
17/08/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Polyphenols are natural components of most plants. Major food sources are berries, fruits, coffee, tea, chocolate, wine, beer, vegetables, legumes and cereals. The most convincing evidence of the benefits of polyphenols for health is the protection against heart diseases. Besides this evidence, polyphenols may also play a role in the prevention of other diseases such as diabetes, neurodegenerative diseases and cancer. The protective properties of polyphenols against cancer have been well documented in a number of animal studies. Progress has been hampered by the limited availability of data on the content of polyphenols in foods. The main database on polyphenol content in foods used so far was developed by the United States Department of Agriculture. However, this database does not cover the wide diversity of polyphenols found in foods. To address this gap, a new comprehensive database on polyphenol contents in foods, Phenol-Explorer (www.phenol-explorer.eu), was recently created. This database represents major progress over the previous tools available. The aim of this study is to use the Phenol-Explorer database to explore the link between polyphenol intake and cancer risk.

Who can participate?
Healthy volunteers aged 30-70 participating in the European Prospective Investigation into Cancer and nutrition (EPIC) study

What does the study involve?
The EPIC participants’ polyphenol intakes are estimated from questionnaires and 24-hour diet recalls. Cancer incidence is assessed using data from national or regional cancer registries, in order to find out if there are links between dietary polyphenol intake and the risk of cancer.

What are the possible benefits and risks of participating?
Due to the observational nature of the study there are no direct benefits for the patient, but they will contribute to the general advance in knowledge for the role of polyphenols in the prevention of cancer. No risks are involved other than minor incidents due to blood sampling.

Where is the study run from?
International Agency for Research on Cancer (France)

When is the study starting and how long is it expected to run for?
August 2010 to June 2014

Who is funding the study?
1. Institut National du Cancer, Paris (INCa)
2. Wereld Kanker Onderzoek Fonds (WCRF)
3. Hellenic Health Foundation

Who is the main contact?
Dr Augustin Scalbert
scalberta@iarc.fr

Contact information

Dr Augustin Scalbert
Scientific

150 cours Albert Thomas
Lyon
69372
France

Phone +33 (0)472 738 095
Email scalberta@iarc.fr

Study information

Study designProspective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Community
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleDietary intakes in polyphenols and risk of cancers in the EPIC cohort
Study objectivesPolyphenols are plant secondary metabolites ubiquitously found in plant-based foods. Given their antioxidant, antiproliferative and antiapoptotic properties and their average consumption of over one gram per day in most diets, the hypothesis is that some polyphenols protect against certain types of cancers.
Ethics approval(s)All the centers participating in the European Prospective Investigation into Cancer and Nutrition (EPIC) received ethics approval from their respective institutions before recruitment of the first participant.

International Agency for Research on Cancer Ethics Committee (IEC), 16/12/2014, ref: IEC Meeting 14-05
Health condition(s) or problem(s) studiedCancer of the breast, prostate, endometrium, ovary, lung and thyroid
InterventionPolyphenol intakes of the EPIC participants were estimated from dietary questionnaires (DQ) administered at baseline and from 24-hour diet recalls (24HDR) used in the calibration sub-study. A large polyphenol food composition table was first developed for the 24HDR foods and using the data available in Phenol-explorer, a unique and comprehensive database on polyphenol contents in foods that was created through a rigorous compilation of 60,000 original content values from the scientific literature (www.phenol-explorer.eu). Phenol-Explorer includes mean content values for 500 polyphenols in more than 450 food and beverage items. This consisted of matching ~20,000 food items between EPIC and Phenol-Explorer foods and correcting for loss during food processing using retention factors. The EPIC polyphenol food composition table was then linked to the DQ foods. Polyphenol intakes of the EPIC participants were calculated from both dietary assessment approaches across all EPIC centres. Dietary sources of polyphenols were then identified and variability within Europe was measured.

The trialists prospectively examined associations between dietary intakes in polyphenols in the different centres of the EPIC cohort and the risk of cancer during follow-up from baseline to 2007. Cox proportional hazards regression models were used to estimate relative risks and 95% confidence intervals. Multivariable models were adjusted on known risk factors for each cancer site studied to account for confounding. Interactions with potential effect modification factors, which could provide new insights into mechanistic pathways, was investigated and stratified analyses performed when needed.
Intervention typeOther
Primary outcome measureCancer incidence, assessed by record linkage with national or regional cancer registries approximately every two years during the study from baseline to 2007
Secondary outcome measuresTotal and individual polyphenol intake across EPIC and socio-demographic factors associated with polyphenol intake, assessed at baseline, between 1992 and 2000 depending on the EPIC centre
Overall study start date01/08/2010
Completion date10/06/2014

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants500,000 overall for 10 European countries, number varies by EPIC country/center
Key inclusion criteria1. Healthy volunteers residing within defined geographical areas, with some exceptions: women of a health insurance company for teachers and school workers (France), women attending breast cancer screening (Utrecht-The Netherlands, and Florence-Italy), mainly blood donors (most centers in Italy and Spain) and a cohort consisting predominantly of vegetarians (the ‘health-conscious’ group in Oxford, UK)
2. Aged 30-70
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/09/1992
Date of final enrolment31/12/2000

Locations

Countries of recruitment

  • Denmark
  • England
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • United Kingdom

Study participating centres

Paris, France
69076
France
Athens, Greece
10679
Greece
Aarhus, Denmark
8000
Denmark
Copenhagen
2100
Denmark
Tromso, Norway
9019
Norway
Malmo, Sweden
21119
Sweden
Umea, Sweden
90187
Sweden
Utrecht, Netherlands
3584
Netherlands
Bilthoven, Netherlands
3721
Netherlands
Oxford, UK
OX1 2JD
United Kingdom
Norfolk, UK
NR31 0ED
United Kingdom
Heidelberg, Germany
69120
Germany
Potsdam, Germany
14558
Germany
Asturias, Spain
33005
Spain
Guipuzcoa, Spain
20013
Spain
Navarra, Spain
31003
Spain
Murcia, Spain
30003
Spain
Granada, Spain
18011
Spain
Turin, Italy
10126
Italy
Milan, Italy
20133
Italy
Florence, Italy
50139
Italy
Naples, Italy
80138
Italy
Ragusa, Italy
97100
Italy
IARC, Lyon, France
69372
France
Imperial College London, UK
SW7 2AZ
United Kingdom

Sponsor information

International Agency for Research on Cancer
Research organisation

150 cours Albert Thomas
Lyon
69372
France

ROR logo "ROR" https://ror.org/00v452281

Funders

Funder type

Research organisation

Institut National du Cancer, Paris (INCa)

No information available

Wereld Kanker Onderzoek Fonds (WCRF)

No information available

Hellenic Health Foundation

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPublication in peer reviewed journal.
IPD sharing planThe complete procedure used to estimate polyphenol intakes will be published in the form of a methodological manuscript and with that the EPIC polyphenol database will be made available as an online supplement. Additionally, the following link can be consulted for further details regarding access to the EPIC data: https://epic.iarc.fr/docs/EPIC_Access_Policy_and_Guidelines.pdf

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results: 01/09/2018 Yes No

Editorial Notes

17/08/2018: Publication reference added