ISRCTN ISRCTN14659829
DOI https://doi.org/10.1186/ISRCTN14659829
Secondary identifying numbers MEC-TNO 93/01
Submission date
16/01/2018
Registration date
29/01/2018
Last edited
15/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Ms Floor Scheffers
Public

PO Box 1
Bilthoven
3720 BA
Netherlands

Prof Monique Verschuren
Scientific

PO Box 1
Bilthoven
3720 BA
Netherlands

Ms Anneke Blokstra
Scientific

PO Box 1
Bilthoven
3720 BA
Netherlands

Study information

Study designProspective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Community
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titlePure fruit juice and fruit consumption and the risk of cardiovascular diseases: the EPIC-NL study
Study objectivesPure 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(s)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
Health condition(s) or problem(s) studiedCardiovascular diseases, coronary heart diseases and stroke
InterventionA 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 typeOther
Primary outcome measureCVD morbidity and mortality data obtained through linkage with national registries from baseline (1993 – 1993) to 2010
Secondary outcome measuresCHD and stroke morbidity and mortality data obtained through linkage with national registries from baseline (1993 – 1993) to 2010
Overall study start date01/04/2015
Completion date01/12/2017

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants40,000 overall for EPIC-NL
Key inclusion criteriaThe 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
Key exclusion criteria1. 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
Date of first enrolment11/01/1993
Date of final enrolment24/12/1993

Locations

Countries of recruitment

  • Netherlands

Study participating centres

National Institute for Public Health and the Environment (RIVM)
Antonie van Leeuwenhoeklaan 9
Bilthoven
3721 MA
Netherlands
Julius Center for Health Sciences and Primary Care
Huispost nr. STR 6.131
PO Box 85500
Utrecht
3508 GA
Netherlands

Sponsor information

Netherlands Organisation for Scientific Research (NWO)
Research organisation

PO Box 93138
The Hague
2509 AC
Netherlands

ROR logo "ROR" https://ror.org/01bnjb948

Funders

Funder type

Government

Ministerie van Volksgezondheid, Welzijn en Sport
Government organisation / National government
Alternative name(s)
Dutch Ministry of Health, Welfare and Sport, VWS
Location
Netherlands
ZonMw
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands
World Cancer Research Fund
Private sector organisation / Other non-profit organizations
Alternative name(s)
World Cancer Research Fund UK, WCRF, WCRF UK
Location
United Kingdom
European Commission (DG SANCO)

No information available

Results and Publications

Intention to publish date01/07/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planSubmission to peer-reviewed journal directly after the registration is finished.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2019 15/01/2019 Yes No

Editorial Notes

15/01/2019: Publication reference added.