Fruit juice, fruit, and cardiovascular diseases
| 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
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
Public
PO Box 1
Bilthoven
3720 BA
Netherlands
Scientific
PO Box 1
Bilthoven
3720 BA
Netherlands
Scientific
PO Box 1
Bilthoven
3720 BA
Netherlands
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Pure fruit juice and fruit consumption and the risk of cardiovascular diseases: the EPIC-NL study |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 01/04/2015 |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40,000 overall for EPIC-NL |
| Key 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 |
| Key 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 |
| Date of first enrolment | 11/01/1993 |
| Date of final enrolment | 24/12/1993 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Bilthoven
3721 MA
Netherlands
PO Box 85500
Utrecht
3508 GA
Netherlands
Sponsor information
Research organisation
PO Box 93138
The Hague
2509 AC
Netherlands
"ROR" |
https://ror.org/01bnjb948 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Dutch Ministry of Health, Welfare and Sport, VWS
- Location
- Netherlands
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- World Cancer Research Fund UK, WCRF, WCRF UK
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/07/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Submission to peer-reviewed journal directly after the registration is finished. |
| IPD sharing plan | 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. |
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.
