Condition category
Cancer
Date applied
10/10/2017
Date assigned
12/10/2017
Last edited
11/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Augustin Scalbert

ORCID ID

Contact details

150 cours Albert Thomas
Lyon
69372
France
+33 (0)472 738 095
scalberta@iarc.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WCRF NL 2012/604

Study information

Scientific title

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

Acronym

Study hypothesis

Polyphenols 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

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

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Cancer of the breast, prostate, endometrium, ovary, lung and thyroid

Intervention

Polyphenol 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 type

Other

Phase

Drug names

Primary outcome measures

Cancer incidence, assessed by record linkage with national or regional cancer registries approximately every two years during the study from baseline to 2007

Secondary outcome measures

Total 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 trial start date

01/08/2010

Overall trial end date

10/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

500,000 overall for 10 European countries, number varies by EPIC country/center

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/1992

Recruitment end date

31/12/2000

Locations

Countries of recruitment

Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom

Trial participating centre

Paris, France
69076

Trial participating centre

Athens, Greece
10679

Trial participating centre

Aarhus, Denmark
8000

Trial participating centre

Copenhagen
2100

Trial participating centre

Tromso, Norway
9019

Trial participating centre

Malmo, Sweden
21119

Trial participating centre

Umea, Sweden
90187

Trial participating centre

Utrecht, Netherlands
3584

Trial participating centre

Bilthoven, Netherlands
3721

Trial participating centre

Oxford, UK
OX1 2JD

Trial participating centre

Norfolk, UK
NR31 0ED

Trial participating centre

Heidelberg, Germany
69120

Trial participating centre

Potsdam, Germany
14558

Trial participating centre

Asturias, Spain
33005

Trial participating centre

Guipuzcoa, Spain
20013

Trial participating centre

Navarra, Spain
31003

Trial participating centre

Murcia, Spain
30003

Trial participating centre

Granada, Spain
18011

Trial participating centre

Turin, Italy
10126

Trial participating centre

Milan, Italy
20133

Trial participating centre

Florence, Italy
50139

Trial participating centre

Naples, Italy
80138

Trial participating centre

Ragusa, Italy
97100

Trial participating centre

IARC, Lyon, France
69372

Trial participating centre

Imperial College London, UK
SW7 2AZ

Sponsor information

Organisation

International Agency for Research on Cancer

Sponsor details

150 cours Albert Thomas
Lyon
69372
France

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Institut National du Cancer, Paris (INCa)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Wereld Kanker Onderzoek Fonds (WCRF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hellenic Health Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in peer reviewed journal.

IPD sharing statement
The 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

Intention to publish date

31/12/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes