Dietary intakes in polyphenols and risk of cancers in the EPIC cohort
ISRCTN | ISRCTN15150764 |
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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
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
Scientific
150 cours Albert Thomas
Lyon
69372
France
Phone | +33 (0)472 738 095 |
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scalberta@iarc.fr |
Study information
Study design | Prospective cohort study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Community |
Study type | Other |
Participant information sheet | No participant information sheet available |
Scientific title | Dietary intakes in polyphenols and risk of cancers in the EPIC cohort |
Study objectives | 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(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) studied | 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 |
Primary outcome measure | 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 study start date | 01/08/2010 |
Completion date | 10/06/2014 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Adult |
Sex | Both |
Target number of participants | 500,000 overall for 10 European countries, number varies by EPIC country/center |
Key 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 |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 01/09/1992 |
Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- Denmark
- England
- France
- Germany
- Greece
- Italy
- Netherlands
- Norway
- Spain
- Sweden
- United Kingdom
Study participating centres
France
Greece
Denmark
Denmark
Norway
Sweden
Sweden
Netherlands
Netherlands
United Kingdom
United Kingdom
Germany
Germany
Spain
Spain
Spain
Spain
Spain
Italy
Italy
Italy
Italy
Italy
France
United Kingdom
Sponsor information
Research organisation
150 cours Albert Thomas
Lyon
69372
France
https://ror.org/00v452281 |
Funders
Funder type
Research organisation
No information available
No information available
No information available
Results and Publications
Intention to publish date | 31/12/2017 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Other |
Publication and dissemination plan | Publication in peer reviewed journal. |
IPD sharing plan | 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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results: | 01/09/2018 | Yes | No |
Editorial Notes
17/08/2018: Publication reference added