Effects of Mediterranean diet on the primary prevention of cardiovascular disease

ISRCTN ISRCTN35739639
DOI https://doi.org/10.1186/ISRCTN35739639
Secondary identifying numbers Red G03/140
Submission date
02/09/2005
Registration date
05/10/2005
Last edited
20/12/2023
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

Not provided at time of registration

Study website

Contact information

Prof Ramon Estruch
Scientific

Servicio de Medicina Interna
Hospital Clinic
Villarroel, 170
Barcelona
08036
Spain

Phone +34 (0)93 227 93 65
Email restruch@clinic.ub.es

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffects of a Mediterranean diet enriched with virgin olive oil or mixed nuts versus a low fat diet on the primary prevention of cardiovascular disease: a randomised controlled trial
Study acronymPREDIMED
Study hypothesisA Mediterranean-style diet enriched with virgin olive oil or mixed nuts prevents cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke).
Ethics approval(s)Institutional Review Board of the Hospital Clinic at Barcelona, Spain, 16/07/2002
ConditionCardiovascular disease
InterventionParticipants are randomly assigned into three equal groups:
1. Mediterranean-style diet with added virgin olive oil
2. Mediterranean-style diet with added nuts
3. Low-fat diet according to American Heart Association guidelines

Added 07/05/2009:
All participants in the three arms will be treated and followed-up yearly from their inclusion to the second semester of 2011.
Intervention typeOther
Primary outcome measureA composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.

Added 07/05/2009:
All participants are evaluated yearly for primary and secondary endpoints.
Secondary outcome measuresDeath of any cause and incidence of angina leading to a revascularisation procedure, heart failure, diabetes mellitus, dementia, and cancer.

Other outcomes:
1. Changes in blood pressure
2. Body weight
3. Adiposity measures
4. Blood sugar
5. Lipid profile
6. Markers of inflammation
7. Other intermediate markers of cardiovascular risk

Added 07/05/2009:
All participants are evaluated yearly for primary and secondary endpoints.
Overall study start date01/10/2003
Overall study end date31/12/2011

Eligibility

Participant type(s)Patient
Age groupSenior
Lower age limit55 Years
Upper age limit80 Years
SexBoth
Target number of participantsn = 7500 high-risk participants
Total final enrolment7447
Participant inclusion criteriaParticipants are community-dwelling high-risk persons aged 55 to 80 for men and aged 60 to 80 for women, without a history of cardiovascular disease (CHD), who fulfill at least one of the two following criteria:
1. Type 2 diabetes
2. Three or more of the risk factors:
2.1. Current smoker
2.2. Hypertension
2.3. Hypercholesterolemia (low density lipoprotein cholesterol [LDL-cholesterol] more than 160 mg/dl or treatment with hypolipidemic drugs)
2.4. High density lipoprotein cholesterol (HDL-cholesterol) less than 40 mg/dl
2.5. Overweight or obesity (body mass index more than 25 kg/m^2)
2.6. Family history of premature CHD
Participant exclusion criteria1. Previous history of cardiovascular disease
2. Any severe chronic illness
3. Immunodeficiency or human immunodeficiency virus (HIV) positive status
4. Illegal drug use or chronic alcoholism
5. History of allergy to olive oil or nuts
6. Low predicted likelihood of changing dietary habits according to the Prochaska and DiClemente stages of change model
Recruitment start date01/10/2003
Recruitment end date31/12/2011

Locations

Countries of recruitment

  • Spain

Study participating centre

Servicio de Medicina Interna
Barcelona
08036
Spain

Sponsor information

Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)
Government

Sinesio Delgado, 6
Madrid
28029
Spain

Phone +34 (0)91 822 21 00
Email Oficina.informacion@isciii.es
Website http://www.isciii.es
ROR logo "ROR" https://ror.org/00ca2c886

Funders

Funder type

Industry

Instituto de Salud Carlos III (ref: G03/140)
Government organisation / National government
Alternative name(s)
SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
Location
Spain
Communal Patrimony Olivarero Foundation (Fundación Patrimonio Comunal Olivarero) (Spain)

No information available

Hojiblanca SA (Spain)

No information available

Borges SA (Spain)

No information available

Morella Nuts SA (Spain)

No information available

California Walnut Commission (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at registration.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 04/07/2006 Yes No
Results article results 11/06/2007 Yes No
Results article results 08/12/2008 Yes No
Results article results 01/06/2011 Yes No
Results article results 01/09/2011 Yes No
Results article results 01/11/2011 Yes No
Results article results 01/01/2012 Yes No
Results article results 01/03/2012 Yes No
Results article sub-study results 01/05/2012 Yes No
Results article results 01/06/2012 Yes No
Results article kidney function results 01/09/2012 Yes No
Results article phylloquinone intake results 01/11/2012 Yes No
Results article sub-study results 06/11/2012 Yes No
Results article primary results 04/04/2013 Yes No
Results article lifestyle and risk factor results 29/04/2013 Yes No
Results article white blood cell results 01/07/2013 Yes No
Results article mortality risk results 16/07/2013 Yes No
Results article sTWEAK concentration results 01/08/2013 Yes No
Results article transcriptomic results 01/09/2013 Yes No
Results article blood pressure results 19/09/2013 Yes No
Results article depression results 20/09/2013 Yes No
Results article gazpacho consumption results 01/10/2013 Yes No
Results article polyphenols results 01/10/2013 Yes No
Results article iron-induced insulin resistance results 22/10/2013 Yes No
Results article polymorphism results 01/11/2013 Yes No
Results article heme iron intake results 04/11/2013 Yes No
Results article cognition sub-study results 01/12/2013 Yes No
Results article magnesium intake results 01/01/2014 Yes No
Results article polymorphism results 06/01/2014 Yes No
Results article prevention of diabetes results 07/01/2014 Yes No
Results article carbohydrate response element binding protein results 01/02/2014 Yes No
Results article carotid intima-media thickness results 01/02/2014 Yes No
Results article plasma fatty acid composition results 20/03/2014 Yes No
Results article beer consumption results 01/04/2014 Yes No
Results article heart failure biomarkers results 01/05/2014 Yes No
Results article vitamin K intake results 01/05/2014 Yes No
Results article olive oil intake results 13/05/2014 Yes No
Results article polyphenol intake results 13/05/2014 Yes No
Results article re-analysis results 13/05/2014 Yes No
Results article habitual polyphenol intake results 01/06/2014 Yes No
Results article vascular wall inflammation and plaque vulnerability results 12/06/2014 Yes No
Results article atrial fibrillation results 01/07/2014 Yes No
Results article results 01/07/2014 Yes No
Results article results 29/07/2014 Yes No
Results article microRNA-410 regulated lipoprotein lipase variant rs13702 results 01/08/2014 Yes No
Results article blood pressure and depression results 26/08/2014 Yes No
Results article results 03/10/2014 Yes No
Other publications metabolic syndrome status 18/11/2014 Yes No
Results article fiber intake results 01/12/2014 Yes No
Results article plasma nitric oxide and blood pressure results 01/01/2015 Yes No
Results article telomere shortening results 01/02/2015 Yes No
Results article results 01/03/2015 Yes No
Results article results 01/07/2015 Yes No
Results article results 01/10/2015 Yes No
Results article results 01/10/2015 Yes No
Results article results 01/11/2015 Yes No
Results article results 01/12/2015 Yes No
Results article results 01/12/2018 Yes No
Results article results 01/05/2019 23/04/2019 Yes No
Results article results 01/06/2019 Yes No
Results article results 01/02/2018 25/07/2019 Yes No
Results article results 01/07/2018 05/08/2019 Yes No
Results article results 01/06/2018 13/09/2019 Yes No
Results article results 01/04/2018 27/09/2019 Yes No
Results article lysine pathway biomarker results 13/11/2019 15/11/2019 Yes No
Results article longitudinal association results 27/12/2019 31/12/2019 Yes No
Results article 6 year follow up results 01/02/2019 26/03/2020 Yes No
Results article results 01/04/2020 26/05/2020 Yes No
Results article results 11/02/2020 13/08/2020 Yes No
Results article results 04/01/2021 10/12/2020 Yes No
Results article results 04/01/2021 10/12/2020 Yes No
Results article Sub-analysis in participants aged over 70 years 28/11/2021 29/11/2021 Yes No
Results article Arginine catabolism metabolites and atrial fibrillation or heart failure risk 16/05/2022 18/05/2022 Yes No
Results article Circulating citric acid cycle metabolites and risk of cardiovascular disease 12/01/2023 06/02/2023 Yes No
Results article AHA proposed 7 ideal cardiovascular health metrics and risk of atrial fibrillation 16/02/2023 24/03/2023 Yes No
Results article Plasma lipidome and risk of atrial fibrillation: results from the PREDIMED trial 01/04/2023 03/04/2023 Yes No
Results article 16/09/2023 18/09/2023 Yes No
Results article Association of diabetes with adherence to Mediterranean diet 29/09/2023 02/10/2023 Yes No
Results article Association between nuclear magnetic resonance spectroscopy markers and adherence to Mediterranean diet 08/11/2023 13/11/2023 Yes No
Results article Association between serum B12 levels and adherence to Mediterranean diet 04/11/2023 13/11/2023 Yes No
Results article Olive oil consumption and T2D and CVD risk 13/12/2023 20/12/2023 Yes No

Editorial Notes

20/12/2023: Publication reference added.
13/11/2023: Publication references added.
02/10/2023: Publication reference added.
18/09/2023: Publication reference added.
03/04/2023: Publication reference added.
24/03/2023: Publication reference added.
06/02/2023: Publication reference added.
18/05/2022: Publication reference added.
29/11/2021: Publication reference added.
10/12/2020: Publication references added.
13/08/2020: Publication reference added.
26/05/2020: Publication reference added.
26/03/2020: Publication reference added.
31/12/2019: Publication reference added.
15/11/2019: Publication reference added.
27/09/2019: Publication reference added.
13/09/2019: Publication reference added.
05/08/2019: Publication reference added.
25/07/2019: Publication reference added.
23/04/2019: The following changes have been made:
1. Publication reference added.
2. The total final enrolment has been added from the results publication.
21/02/2019: Publication reference added.
18/01/2019: Publication reference added.
04/06/2018: Trial website address updated.
14/01/2016: Publication reference added.
05/05/2009: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/12/2010 to 31/12/2011.
2. The target number of participants was changed from 9000 to 7500 high-risk participants.