Effects of Mediterranean diet on the primary prevention of cardiovascular disease
ISRCTN | ISRCTN35739639 |
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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
Plain English Summary
Not provided at time of registration
Contact information
Scientific
Servicio de Medicina Interna
Hospital Clinic
Villarroel, 170
Barcelona
08036
Spain
Phone | +34 (0)93 227 93 65 |
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restruch@clinic.ub.es |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Effects 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 acronym | PREDIMED |
Study hypothesis | A 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 |
Condition | Cardiovascular disease |
Intervention | Participants 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 type | Other |
Primary outcome measure | A 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 measures | Death 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 date | 01/10/2003 |
Overall study end date | 31/12/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Lower age limit | 55 Years |
Upper age limit | 80 Years |
Sex | Both |
Target number of participants | n = 7500 high-risk participants |
Total final enrolment | 7447 |
Participant inclusion criteria | Participants 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 criteria | 1. 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 date | 01/10/2003 |
Recruitment end date | 31/12/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
08036
Spain
Sponsor information
Government
Sinesio Delgado, 6
Madrid
28029
Spain
Phone | +34 (0)91 822 21 00 |
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Oficina.informacion@isciii.es | |
Website | http://www.isciii.es |
https://ror.org/00ca2c886 |
Funders
Funder type
Industry
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
No information available
No information available
No information available
No information available
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not 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.