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Effects of Mediterranean diet on the primary prevention of cardiovascular disease
DOI 10.1186/ISRCTN35739639
ClinicalTrials.gov identifier
EudraCT number
Public title Effects of Mediterranean diet on the primary prevention of cardiovascular disease
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
Serial number at source Red G03/140
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).

On 05/05/2009 the following changes were made to the trial record:
1. The anticipated 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.
Lay summary Not provided at time of registration
Ethics approval Institutional Review Board of the Hospital Clinic at Barcelona, Spain, 16/07/2002
Study design Randomised controlled trial
Countries of recruitment Spain
Disease/condition/study domain Cardiovascular disease
Participants - 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
Participants - 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
Anticipated start date 01/10/2003
Anticipated end date 31/12/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants n = 7500 high-risk participants
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding 1. Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) (ref: G03/140)
2. Communal Patrimony Olivarero Foundation (Fundación Patrimonio Comunal Olivarero) (Spain)
3. Hojiblanca SA (Spain)
4. Borges SA (Spain)
5. Morella Nuts SA (Spain)
6. California Walnut Commission (USA)
Trial website http://www.predimed.org
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16818923
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17563030
3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19064829
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21508208
5. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21708186
6. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21802081
7. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22170359
8. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/20875949
9. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22535754
10. 2012 sub-study results in http://www.ncbi.nlm.nih.gov/pubmed/22420890
11. 2012 kidney function results in http://www.ncbi.nlm.nih.gov/pubmed/22541738
12. 2012 sub-study results in http://www.ncbi.nlm.nih.gov/pubmed/23130628
13. 2012 phylloquinone intake results in http://www.ncbi.nlm.nih.gov/pubmed/23034962
14. 2013 polyphenols results in http://www.ncbi.nlm.nih.gov/pubmed/23332727
15. 2013 primary results in http://www.ncbi.nlm.nih.gov/pubmed/23432189
16. 2013 cognition sub-study results in http://www.ncbi.nlm.nih.gov/pubmed/23670794
17. 2013 mortality risk results in http://www.ncbi.nlm.nih.gov/pubmed/23866098
18. 2013 white blood cell results in: http://www.ncbi.nlm.nih.gov/pubmed/23526980
19. 2013 blood pressure results in: http://www.ncbi.nlm.nih.gov/pubmed/24050803
20. 2013 polymorphism results in: http://www.ncbi.nlm.nih.gov/pubmed/23942586
21. 2013 transcriptomic results in: http://www.ncbi.nlm.nih.gov/pubmed/23902780
22. 2013 sTWEAK concentration results in: http://www.ncbi.nlm.nih.gov/pubmed/23760626
23. 2013 depression results in: http://www.ncbi.nlm.nih.gov/pubmed/24229349
24. 2013 carotid intima-media thickness results in: http://www.ncbi.nlm.nih.gov/pubmed/24285581
25. 2013 lifestyle and risk factor results in: http://www.ncbi.nlm.nih.gov/pubmed/23637743
26. 2013 iron-induced insulin resistance results in: http://www.ncbi.nlm.nih.gov/pubmed/24167545
27. 2013 gazpacho consumption results in: http://www.ncbi.nlm.nih.gov/pubmed/23149074
28. 2014 polymorphism results in: http://www.ncbi.nlm.nih.gov/pubmed/24393375
29. 2014 habitual polyphenol intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24552647
30. 2014 magnesium intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24259558
31. 2014 heart failure biomarkers results in: http://www.ncbi.nlm.nih.gov/pubmed/24574190
32. 2014 prevention of diabetes results in: http://www.ncbi.nlm.nih.gov/pubmed/24573661
33. 2014 beer consumption results in: http://www.ncbi.nlm.nih.gov/pubmed/24477299
34. 2014 olive oil intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24886626
35. 2014 polyphenol intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24886552
36. 2014 vitamin K intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24647393
37. 2014 vascular wall inflammation and plaque vulnerability results in: http://www.ncbi.nlm.nih.gov/pubmed/24925270
38. 2014 microRNA-410 regulated lipoprotein lipase variant rs13702 results in: http://www.ncbi.nlm.nih.gov/pubmed/24990426
Contact name Prof  Ramon  Estruch
  Address Servicio de Medicina Interna
Hospital Clinic
Villarroel, 170
  City/town Barcelona
  Zip/Postcode 08036
  Country Spain
  Tel +34 93 227 93 65
  Fax +34 93 227 93 65
  Email restruch@clinic.ub.es
Sponsor Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)
  Address Sinesio Delgado, 6
  City/town Madrid
  Zip/Postcode 28029
  Country Spain
  Tel +34 91 822 21 00
  Fax +34 91 387 77 89
  Email Oficina.informacion@isciii.es
  Sponsor website: http://www.isciii.es
Date applied 02/09/2005
Last edited 07/07/2014
Date ISRCTN assigned 05/10/2005
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