Condition category
Circulatory System
Date applied
16/01/2018
Date assigned
29/01/2018
Last edited
29/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Netherlands Organisation for Scientific Research (NWO)

Sponsor details

PO Box 93138
The Hague
2509 AC
Netherlands

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes