Plain English Summary
Background and study aims
Dietary guidelines for replacing fruit with pure fruit juice differ between countries from ‘half of the recommended fruit intake may be replaced by pure fruit juice’ up to ‘keep consumption of pure fruit juice to a minimum’. Fruit juice contains less dietary fiber and vitamin C than whole fruits. However, pure fruit juice still contains a high concentration of polyphenols which might reduce the risk of cardiovascular (heart) disease (CVD). Research on pure fruit juice is limited to risk factors of CVD such as blood pressure and serum cholesterol. The aim of this study is to investigate the association of pure fruit juice and fruit consumption with CVD, and to assess the association between fruit juice consumption and CVD for low and high fruit consumers.
Who can participate?
Participants from the EPIC-NL study: men and women aged 20 – 65 years selected from random samples of the Dutch population in three towns in the Netherlands (Amsterdam, Doetinchem, Maastricht), and women from the Dutch town Utrecht or its vicinity, who participated in a breast cancer screening program
What does the study involve?
A food frequency questionnaire is used to estimate fruit and fruit juice consumption of 35,620 Dutch men and women from the EPIC-NL study. CVD, coronary heart disease (CHD) and stroke morbidity (illness) and mortality (death) data are obtained through linkage with national registries.
What are the possible benefits and risks of participating?
This study is an observational study and therefore there are neither benefits nor risks of participating. However, participating will contribute to more knowledge about the association between fruit juice consumption and CVD.
Where is the study run from?
National Institute for Public Health and the Environment (RIVM) and the Julius Center for Health Sciences and Primary Care (Netherlands)
When is the study starting and how long is it expected to run for?
April 2015 to December 2017
Who is funding the study?
1. “Europe against Cancer” Programme of the European Commission (DG SANCO)
2. The Dutch Ministry of Health, Welfare and Sports (VWS)
3. The Netherlands Organisation for Health Research and Development (ZonMW)
4. The World Cancer Research Fund (WCRF)
Who is the main contact?
1. F.R. Scheffers
2. W.M.M. Verschuren
3. A. Blokstra
Trial website
Contact information
Type
Public
Primary contact
Ms Floor Scheffers
ORCID ID
Contact details
PO Box 1
Bilthoven
3720 BA
Netherlands
Type
Scientific
Additional contact
Prof Monique Verschuren
ORCID ID
Contact details
PO Box 1
Bilthoven
3720 BA
Netherlands
Type
Scientific
Additional contact
Ms Anneke Blokstra
ORCID ID
Contact details
PO Box 1
Bilthoven
3720 BA
Netherlands
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC-TNO 93/01
Study information
Scientific title
Pure fruit juice and fruit consumption and the risk of cardiovascular diseases: the EPIC-NL study
Acronym
Study hypothesis
Pure fruit juice contains less dietary fiber and vitamin C than whole fruits. However, pure fruit juice still contains a high concentration of polyphenols which might reduce the risk of CVD. Therefore, pure fruit juice may protect against CVD.
Ethics approval
1. Prospect cohort: Institutional board of the University Medical Center Utrecht, 28/7/1993, ref: WOM-93/090
2. MORGEN cohort: Medical Ethical Committee of TNO Nutrition and Food Research, 06/04/1993, ref: MEC-TNO 93/01
Study design
Prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Community
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cardiovascular diseases, coronary heart diseases and stroke
Intervention
A validated FFQ was used to estimate the dietary intake of 35,620 Dutch men and women from the EPIC-NL study. CVD, CHD and stroke morbidity and mortality data were obtained through linkage with national registries. Cox regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) adjusted for several counfounders. Interactions with potential effect modification factors were investigated.
Intervention type
Other
Phase
Drug names
Primary outcome measure
CVD morbidity and mortality data obtained through linkage with national registries from baseline (1993 – 1993) to 2010
Secondary outcome measures
CHD and stroke morbidity and mortality data obtained through linkage with national registries from baseline (1993 – 1993) to 2010
Overall trial start date
01/04/2015
Overall trial end date
01/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The EPIC-NL study consists of two cohorts:
1. The MORGEN cohort consists of men and women aged 20 – 65 years selected from random samples of the Dutch population in three towns in the Netherlands (Amsterdam, Doetinchem, Maastricht)
2. The Prospect cohort consists of women from the Dutch town Utrecht or its vicinity, who participated in a breast cancer screening program
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
40,000 overall for EPIC-NL
Participant exclusion criteria
1. Missing food-frequency questionnaire (FFQ)
2. Extremely low or high reported energy intake (i.e. those in the lowest or highest 0.5% of the ratio of energy intake over basal metabolic rate)
3. No permission to link with the Dutch Hospital Discharge Diagnosis Database
4. Missing vital status
5. Missing cause of death
6. Prevalent CVD at baseline based on self-report or identified through linkage with the Dutch Hospital Discharge Diagnosis Database
7. Prevalent Diabetes Mellitus at baseline based on self-report, or missing data on confounders
Recruitment start date
11/01/1993
Recruitment end date
24/12/1993
Locations
Countries of recruitment
Netherlands
Trial participating centre
National Institute for Public Health and the Environment (RIVM)
Antonie van Leeuwenhoeklaan 9
Bilthoven
3721 MA
Netherlands
Trial participating centre
Julius Center for Health Sciences and Primary Care
Huispost nr. STR 6.131
PO Box 85500
Utrecht
3508 GA
Netherlands
Funders
Funder type
Government
Funder name
Ministerie van Volksgezondheid, Welzijn en Sport
Alternative name(s)
Dutch Ministry of Health, Welfare and Sport, VWS
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Netherlands
Funder name
ZonMw
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Funder name
World Cancer Research Fund
Alternative name(s)
WCRF UK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
European Commission (DG SANCO)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submission to peer-reviewed journal directly after the registration is finished.
IPD sharing statement
The datasets analysed during the current study and all EPIC-NL data are available upon request for scientific research (no commercial aims) and after signing a material transfer agreement. An EPIC-NL data-request form needs to be filled out and sent to J.J.Metselaar@umcutrecht.nl or epicnl@umcutrecht.nl. Data will be-anonymised to the extent that they are not tracable to any individual, e.g. no names, adresses, birth dates etc. will be provided (only age in years). A data management fee is requested.
Intention to publish date
01/07/2018
Participant level data
Available on request
Basic results (scientific)
Publication list