Condition category
Circulatory System
Date applied
02/09/2005
Date assigned
05/10/2005
Last edited
17/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.predimed.org

Contact information

Type

Scientific

Primary contact

Prof Ramon Estruch

ORCID ID

Contact details

Servicio de Medicina Interna
Hospital Clinic
Villarroel
170
Barcelona
08036
Spain
+34 93 227 93 65
restruch@clinic.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Red G03/140

Study information

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

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).

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.

Ethics approval

Institutional Review Board of the Hospital Clinic at Barcelona, Spain, 16/07/2002

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Drug

Phase

Not Applicable

Drug names

Mediterranean-style diet with added virgin olive oil or with added nuts, low-fat diet

Primary outcome measures

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 trial start date

01/10/2003

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Both

Target number of participants

n = 7500 high-risk participants

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

Trial participating centre

Servicio de Medicina Interna
Barcelona
08036
Spain

Sponsor information

Organisation

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

Sponsor details

Sinesio Delgado
6
Madrid
28029
Spain
+34 91 822 21 00
Oficina.informacion@isciii.es

Sponsor type

Government

Website

http://www.isciii.es

Funders

Funder type

Industry

Funder name

Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) (ref: G03/140)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Communal Patrimony Olivarero Foundation (Fundación Patrimonio Comunal Olivarero) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hojiblanca SA (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Borges SA (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Morella Nuts SA (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

California Walnut Commission (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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. 2013 heme iron intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24188615
29. 2014 polymorphism results in: http://www.ncbi.nlm.nih.gov/pubmed/24393375
30. 2014 habitual polyphenol intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24552647
31. 2014 magnesium intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24259558
32. 2014 heart failure biomarkers results in: http://www.ncbi.nlm.nih.gov/pubmed/24574190
33. 2014 prevention of diabetes results in: http://www.ncbi.nlm.nih.gov/pubmed/24573661
34. 2014 beer consumption results in: http://www.ncbi.nlm.nih.gov/pubmed/24477299
35. 2014 olive oil intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24886626
36. 2014 polyphenol intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24886552
37. 2014 vitamin K intake results in: http://www.ncbi.nlm.nih.gov/pubmed/24647393
38. 2014 vascular wall inflammation and plaque vulnerability results in: http://www.ncbi.nlm.nih.gov/pubmed/24925270
39. 2014 microRNA-410 regulated lipoprotein lipase variant rs13702 results in: http://www.ncbi.nlm.nih.gov/pubmed/24990426
40. 2014 atrial fibrillation results in: http://www.ncbi.nlm.nih.gov/pubmed/24787471
41. 2014 metabolic syndrome status in: http://www.ncbi.nlm.nih.gov/pubmed/25316904
42. 2014 plasma nitric oxide and blood pressure results in: http://www.ncbi.nlm.nih.gov/pubmed/25315667
43. 2014 carbohydrate response element binding protein results in: http://www.ncbi.nlm.nih.gov/pubmed/24448738
44. 2014 telomere shortening results in: http://www.ncbi.nlm.nih.gov/pubmed/25406242

Publication citations

  1. Results

    Estruch R, Martínez-González MA, Corella D, Salas-Salvadó J, Ruiz-Gutiérrez V, Covas MI, Fiol M, Gómez-Gracia E, López-Sabater MC, Vinyoles E, Arós F, Conde M, Lahoz C, Lapetra J, Sáez G, Ros E, , Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial., Ann. Intern. Med., 2006, 145, 1, 1-11.

  2. Results

    Fitó M, Guxens M, Corella D, Sáez G, Estruch R, de la Torre R, Francés F, Cabezas C, López-Sabater Mdel C, Marrugat J, García-Arellano A, Arós F, Ruiz-Gutierrez V, Ros E, Salas-Salvadó J, Fiol M, Solá R, Covas MI, , Effect of a traditional Mediterranean diet on lipoprotein oxidation: a randomized controlled trial., Arch. Intern. Med., 2007, 167, 11, 1195-1203, doi: 10.1001/archinte.167.11.1195.

  3. Results

    Salas-Salvadó J, Fernández-Ballart J, Ros E, Martínez-González MA, Fitó M, Estruch R, Corella D, Fiol M, Gómez-Gracia E, Arós F, Flores G, Lapetra J, Lamuela-Raventós R, Ruiz-Gutiérrez V, Bulló M, Basora J, Covas MI, , Effect of a Mediterranean diet supplemented with nuts on metabolic syndrome status: one-year results of the PREDIMED randomized trial., Arch. Intern. Med., 2008, 168, 22, 2449-2458, doi: 10.1001/archinte.168.22.2449.

  4. Results

    Schröder H, Fitó M, Estruch R, Martínez-González MA, Corella D, Salas-Salvadó J, Lamuela-Raventós R, Ros E, Salaverría I, Fiol M, Lapetra J, Vinyoles E, Gómez-Gracia E, Lahoz C, Serra-Majem L, Pintó X, Ruiz-Gutierrez V, Covas MI, A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women., J. Nutr., 2011, 141, 6, 1140-1145, doi: 10.3945/jn.110.135566.

  5. Results

    Bulló M, Garcia-Aloy M, Martínez-González MA, Corella D, Fernández-Ballart JD, Fiol M, Gómez-Gracia E, Estruch R, Ortega-Calvo M, Francisco S, Flores-Mateo G, Serra-Majem L, Pintó X, Covas MI, Ros E, Lamuela-Raventós R, Salas-Salvadó J, Association between a healthy lifestyle and general obesity and abdominal obesity in an elderly population at high cardiovascular risk., Prev Med, 2011, 53, 3, 155-161, doi: 10.1016/j.ypmed.2011.06.008.

  6. Results

    Murie-Fernandez M, Irimia P, Toledo E, Martínez-Vila E, Buil-Cosiales P, Serrano-Martínez M, Ruiz-Gutiérrez V, Ros E, Estruch R, Martínez-González MÁ, , Carotid intima-media thickness changes with Mediterranean diet: a randomized trial (PREDIMED-Navarra)., Atherosclerosis, 2011, 219, 1, 158-162, doi: 10.1016/j.atherosclerosis.2011.06.050.

  7. Results

    Bulló M, Moreno-Navarrete JM, Fernández-Real JM, Salas-Salvadó J, Total and undercarboxylated osteocalcin predict changes in insulin sensitivity and β cell function in elderly men at high cardiovascular risk., Am. J. Clin. Nutr., 2012, 95, 1, 249-255, doi: 10.3945/ajcn.111.016642.

  8. Results

    Babio N, Sorlí M, Bulló M, Basora J, Ibarrola-Jurado N, Fernández-Ballart J, Martínez-González MA, Serra-Majem L, González-Pérez R, Salas-Salvadó J, , Association between red meat consumption and metabolic syndrome in a Mediterranean population at high cardiovascular risk: cross-sectional and 1-year follow-up assessment., Nutr Metab Cardiovasc Dis, 2012, 22, 3, 200-207, doi: 10.1016/j.numecd.2010.06.011.

  9. Results

    Urpi-Sarda M, Casas R, Chiva-Blanch G, Romero-Mamani ES, Valderas-Martínez P, Salas-Salvadó J, Covas MI, Toledo E, Andres-Lacueva C, Llorach R, García-Arellano A, Bulló M, Ruiz-Gutierrez V, Lamuela-Raventos RM, Estruch R, The Mediterranean diet pattern and its main components are associated with lower plasma concentrations of tumor necrosis factor receptor 60 in patients at high risk for cardiovascular disease., J. Nutr., 2012, 142, 6, 1019-1025, doi: 10.3945/jn.111.148726.

  10. Kidney function results

    Díaz-López A, Bulló M, Martínez-González MÁ, Guasch-Ferré M, Ros E, Basora J, Covas MI, del Carmen López-Sabater M, Salas-Salvadó J, , Effects of Mediterranean diets on kidney function: a report from the PREDIMED trial., Am. J. Kidney Dis., 2012, 60, 3, 380-389, doi: 10.1053/j.ajkd.2012.02.334.

  11. Phylloquinone intake results

    Ibarrola-Jurado N, Salas-Salvadó J, Martínez-González MA, Bulló M, Dietary phylloquinone intake and risk of type 2 diabetes in elderly subjects at high risk of cardiovascular disease., Am. J. Clin. Nutr., 2012, 96, 5, 1113-1118, doi: 10.3945/ajcn.111.033498.

  12. Polyphenols results

    Tresserra-Rimbau A, Medina-Remón A, Pérez-Jiménez J, Martínez-González MA, Covas MI, Corella D, Salas-Salvadó J, Gómez-Gracia E, Lapetra J, Arós F, Fiol M, Ros E, Serra-Majem L, Pintó X, Muñoz MA, Saez GT, Ruiz-Gutiérrez V, Warnberg J, Estruch R, Lamuela-Raventós RM, Dietary intake and major food sources of polyphenols in a Spanish population at high cardiovascular risk: the PREDIMED study., Nutr Metab Cardiovasc Dis, 2013, 23, 10, 953-959, doi: 10.1016/j.numecd.2012.10.008.

  13. Primary results

    Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Martínez-González MA, , Primary prevention of cardiovascular disease with a Mediterranean diet., N. Engl. J. Med., 2013, 368, 14, 1279-1290, doi: 10.1056/NEJMoa1200303.

  14. Mortality risk results

    Guasch-Ferré M, Bulló M, Martínez-González MÁ, Ros E, Corella D, Estruch R, Fitó M, Arós F, Wärnberg J, Fiol M, Lapetra J, Vinyoles E, Lamuela-Raventós RM, Serra-Majem L, Pintó X, Ruiz-Gutiérrez V, Basora J, Salas-Salvadó J, , Frequency of nut consumption and mortality risk in the PREDIMED nutrition intervention trial., BMC Med, 2013, 11, 164, doi: doi:10.1186/1741-7015-11-164.

  15. White blood cell results

    Babio N, Ibarrola-Jurado N, Bulló M, Martínez-González MÁ, Wärnberg J, Salaverría I, Ortega-Calvo M, Estruch R, Serra-Majem L, Covas MI, Sorli JV, Salas-Salvadó J, , White blood cell counts as risk markers of developing metabolic syndrome and its components in the PREDIMED study., PLoS ONE, 2013, 8, 3, e58354, doi: 10.1371/journal.pone.0058354.

  16. Blood pressure results

    Toledo E, Hu FB, Estruch R, Buil-Cosiales P, Corella D, Salas-Salvadó J, Covas MI, Arós F, Gómez-Gracia E, Fiol M, Lapetra J, Serra-Majem L, Pinto X, Lamuela-Raventós RM, Saez G, Bulló M, Ruiz-Gutiérrez V, Ros E, Sorli JV, Martinez-Gonzalez MA, Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial., BMC Med, 2013, 11, 207, doi: 10.1186/1741-7015-11-207.

  17. Polymorphism results

    Corella D, Carrasco P, Sorlí JV, Estruch R, Rico-Sanz J, Martínez-González MÁ, Salas-Salvadó J, Covas MI, Coltell O, Arós F, Lapetra J, Serra-Majem L, Ruiz-Gutiérrez V, Warnberg J, Fiol M, Pintó X, Ortega-Azorín C, Muñoz MÁ, Martínez JA, Gómez-Gracia E, González JI, Ros E, Ordovás JM, Mediterranean diet reduces the adverse effect of the TCF7L2-rs7903146 polymorphism on cardiovascular risk factors and stroke incidence: a randomized controlled trial in a high-cardiovascular-risk population., Diabetes Care, 2013, 36, 11, 3803-3811, doi: 10.2337/dc13-0955.

  18. Transcriptomic results

    Castañer O, Corella D, Covas MI, Sorlí JV, Subirana I, Flores-Mateo G, Nonell L, Bulló M, de la Torre R, Portolés O, Fitó M, , In vivo transcriptomic profile after a Mediterranean diet in high-cardiovascular risk patients: a randomized controlled trial., Am. J. Clin. Nutr., 2013, 98, 3, 845-853, doi: 10.3945/ajcn.113.060582.

  19. STWEAK concentration results

    Díaz-López A, Chacón MR, Bulló M, Maymó-Masip E, Martínez-González MA, Estruch R, Vendrell J, Basora J, Díez-Espino J, Covas MI, Salas-Salvadó J, Serum sTWEAK concentrations and risk of developing type 2 diabetes in a high cardiovascular risk population: a nested case-control study., J. Clin. Endocrinol. Metab., 2013, 98, 8, 3482-3490, doi: 10.1210/jc.2013-1848.

  20. Depression results

    Sánchez-Villegas A, Martínez-González MA, Estruch R, Salas-Salvadó J, Corella D, Covas MI, Arós F, Romaguera D, Gómez-Gracia E, Lapetra J, Pintó X, Martínez JA, Lamuela-Raventós RM, Ros E, Gea A, Wärnberg J, Serra-Majem L, Mediterranean dietary pattern and depression: the PREDIMED randomized trial., BMC Med, 2013, 11, 208, doi: 10.1186/1741-7015-11-208.

  21. Lifestyle and risk factor results

    Hu EA, Toledo E, Diez-Espino J, Estruch R, Corella D, Salas-Salvado J, Vinyoles E, Gomez-Gracia E, Aros F, Fiol M, Lapetra J, Serra-Majem L, Pintó X, Portillo MP, Lamuela-Raventos RM, Ros E, Sorli JV, Martinez-Gonzalez MA, Lifestyles and risk factors associated with adherence to the Mediterranean diet: a baseline assessment of the PREDIMED trial., PLoS ONE, 2013, 8, 4, e60166, doi: 10.1371/journal.pone.0060166.

  22. Gazpacho consumption results

    Medina-Remón A, Vallverdú-Queralt A, Arranz S, Ros E, Martínez-González MA, Sacanella E, Covas MI, Corella D, Salas-Salvadó J, Gómez-Gracia E, Ruiz-Gutiérrez V, Lapetra J, García-Valdueza M, Arós F, Saez GT, Serra-Majem L, Pinto X, Vinyoles E, Estruch R, Lamuela-Raventos RM, Gazpacho consumption is associated with lower blood pressure and reduced hypertension in a high cardiovascular risk cohort. Cross-sectional study of the PREDIMED trial., Nutr Metab Cardiovasc Dis, 2013, 23, 10, 944-952, doi: 10.1016/j.numecd.2012.07.008.

  23. Heme iron intake results

    Fernandez-Cao JC, Arija V, Aranda N, Bullo M, Basora J, Martínez-González MA, Díez-Espino J, Salas-Salvadó J, Heme iron intake and risk of new-onset diabetes in a Mediterranean population at high risk of cardiovascular disease: an observational cohort analysis., BMC Public Health, 2013, 13, 1042, doi: 10.1186/1471-2458-13-1042.

  24. Polymorphism results

    Corella D, Sorlí JV, González JI, Ortega C, Fitó M, Bulló M, Martínez-González MA, Ros E, Arós F, Lapetra J, Gómez-Gracia E, Serra-Majem L, Ruiz-Gutierrez V, Fiol M, Coltell O, Vinyoles E, Pintó X, Martí A, Saiz C, Ordovás JM, Estruch R, Novel association of the obesity risk-allele near Fas Apoptotic Inhibitory Molecule 2 (FAIM2) gene with heart rate and study of its effects on myocardial infarction in diabetic participants of the PREDIMED trial., Cardiovasc Diabetol, 2014, 13, 5, doi: 10.1186/1475-2840-13-5.

  25. Habitual polyphenol intake results

    Tresserra-Rimbau A, Rimm EB, Medina-Remón A, Martínez-González MA, de la Torre R, Corella D, Salas-Salvadó J, Gómez-Gracia E, Lapetra J, Arós F, Fiol M, Ros E, Serra-Majem L, Pintó X, Saez GT, Basora J, Sorlí JV, Martínez JA, Vinyoles E, Ruiz-Gutiérrez V, Estruch R, Lamuela-Raventós RM, , Inverse association between habitual polyphenol intake and incidence of cardiovascular events in the PREDIMED study., Nutr Metab Cardiovasc Dis, 2014, 24, 6, 639-647, doi: 10.1016/j.numecd.2013.12.014.

  26. Magnesium intake results

    Guasch-Ferré M, Bulló M, Estruch R, Corella D, Martínez-González MA, Ros E, Covas M, Arós F, Gómez-Gracia E, Fiol M, Lapetra J, Muñoz MÁ, Serra-Majem L, Babio N, Pintó X, Lamuela-Raventós RM, Ruiz-Gutiérrez V, Salas-Salvadó J, , Dietary magnesium intake is inversely associated with mortality in adults at high cardiovascular disease risk., J. Nutr., 2014, 144, 1, 55-60, doi: 10.3945/jn.113.183012.

  27. Heart failure biomarkers results

    Fitó M, Estruch R, Salas-Salvadó J, Martínez-Gonzalez MA, Arós F, Vila J, Corella D, Díaz O, Sáez G, de la Torre R, Mitjavila MT, Muñoz MA, Lamuela-Raventós RM, Ruiz-Gutierrez V, Fiol M, Gómez-Gracia E, Lapetra J, Ros E, Serra-Majem L, Covas MI, , Effect of the Mediterranean diet on heart failure biomarkers: a randomized sample from the PREDIMED trial., Eur. J. Heart Fail., 2014, 16, 5, 543-550, doi: 10.1002/ejhf.61.

  28. Prevention of diabetes results

    Salas-Salvadó J, Bulló M, Estruch R, Ros E, Covas MI, Ibarrola-Jurado N, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Romaguera D, Lapetra J, Lamuela-Raventós RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez-González MA, Prevention of diabetes with Mediterranean diets: a subgroup analysis of a randomized trial., Ann. Intern. Med., 2014, 160, 1, 1-10, doi: 10.7326/M13-1725.

  29. Beer consumption results

    Quifer-Rada P, Martínez-Huélamo M, Chiva-Blanch G, Jáuregui O, Estruch R, Lamuela-Raventós RM, Urinary isoxanthohumol is a specific and accurate biomarker of beer consumption., J. Nutr., 2014, 144, 4, 484-488, doi: 10.3945/jn.113.185199.

  30. Olive oil intake results

    Guasch-Ferré M, Hu FB, Martínez-González MA, Fitó M, Bulló M, Estruch R, Ros E, Corella D, Recondo J, Gómez-Gracia E, Fiol M, Lapetra J, Serra-Majem L, Muñoz MA, Pintó X, Lamuela-Raventós RM, Basora J, Buil-Cosiales P, Sorlí JV, Ruiz-Gutiérrez V, Martínez JA, Salas-Salvadó J, Olive oil intake and risk of cardiovascular disease and mortality in the PREDIMED Study., BMC Med, 2014, 12, 78, doi: 10.1186/1741-7015-12-78.

  31. Polyphenol intake results

    Tresserra-Rimbau A, Rimm EB, Medina-Remón A, Martínez-González MA, López-Sabater MC, Covas MI, Corella D, Salas-Salvadó J, Gómez-Gracia E, Lapetra J, Arós F, Fiol M, Ros E, Serra-Majem L, Pintó X, Muñoz MA, Gea A, Ruiz-Gutiérrez V, Estruch R, Lamuela-Raventós RM, , Polyphenol intake and mortality risk: a re-analysis of the PREDIMED trial., BMC Med, 2014, 12, 77, doi: 10.1186/1741-7015-12-77.

  32. Vitamin K intake results

    Juanola-Falgarona M, Salas-Salvadó J, Martínez-González MÁ, Corella D, Estruch R, Ros E, Fitó M, Arós F, Gómez-Gracia E, Fiol M, Lapetra J, Basora J, Lamuela-Raventós RM, Serra-Majem L, Pintó X, Muñoz MÁ, Ruiz-Gutiérrez V, Fernández-Ballart J, Bulló M, Dietary intake of vitamin K is inversely associated with mortality risk., J. Nutr., 2014, 144, 5, 743-750, doi: 10.3945/jn.113.187740.

  33. Vascular wall inflammation and plaque vulnerability results

    Casas R, Sacanella E, Urpí-Sardà M, Chiva-Blanch G, Ros E, Martínez-González MA, Covas MI, , Salas-Salvadó J, Fiol M, Arós F, Estruch R, The effects of the mediterranean diet on biomarkers of vascular wall inflammation and plaque vulnerability in subjects with high risk for cardiovascular disease. A randomized trial., PLoS ONE, 2014, 9, 6, e100084, doi: 10.1371/journal.pone.0100084.

  34. Atrial fibrillation results

    Martínez-González MÁ, Toledo E, Arós F, Fiol M, Corella D, Salas-Salvadó J, Ros E, Covas MI, Fernández-Crehuet J, Lapetra J, Muñoz MA, Fitó M, Serra-Majem L, Pintó X, Lamuela-Raventós RM, Sorlí JV, Babio N, Buil-Cosiales P, Ruiz-Gutierrez V, Estruch R, Alonso A, , Extravirgin olive oil consumption reduces risk of atrial fibrillation: the PREDIMED (Prevención con Dieta Mediterránea) trial., Circulation, 2014, 130, 1, 18-26, doi: 10.1161/CIRCULATIONAHA.113.006921.

  35. Metabolic syndrome status

    Babio N, Toledo E, Estruch R, Ros E, Martínez-González MA, Castañer O, Bulló M, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Sorlí JV, Salas-Salvadó J, , Mediterranean diets and metabolic syndrome status in the PREDIMED randomized trial., CMAJ, 2014, doi: 10.1503/cmaj.140764.

  36. Plasma nitric oxide and blood pressure results

    Medina-Remón A, Tresserra-Rimbau A, Pons A, Tur JA, Martorell M, Ros E, Buil-Cosiales P, Sacanella E, Covas MI, Corella D, Salas-Salvadó J, Gómez-Gracia E, Ruiz-Gutiérrez V, Ortega-Calvo M, García-Valdueza M, Arós F, Saez GT, Serra-Majem L, Pinto X, Vinyoles E, Estruch R, Lamuela-Raventos RM, , Effects of total dietary polyphenols on plasma nitric oxide and blood pressure in a high cardiovascular risk cohort. The PREDIMED randomized trial., Nutr Metab Cardiovasc Dis, 2014, doi: 10.1016/j.numecd.2014.09.001.

  37. Carbohydrate response element binding protein results

    Ortega-Azorín C, Sorlí JV, Estruch R, Asensio EM, Coltell O, González JI, Martínez-González MÁ, Ros E, Salas-Salvadó J, Fitó M, Arós F, Lapetra J, Serra-Majem L, Ruiz-Gutiérrez V, Gómez-Gracia E, Fiol M, Flores G, Pintó X, Saiz C, Ordovás JM, Corella D, Amino acid change in the carbohydrate response element binding protein is associated with lower triglycerides and myocardial infarction incidence depending on level of adherence to the Mediterranean diet in the PREDIMED trial., Circ Cardiovasc Genet, 2014, 7, 1, 49-58, doi: 10.1161/CIRCGENETICS.113.000301.

  38. Cabré A, Babio N, Lázaro I, Bulló M, Garcia-Arellano A, Masana L, Salas-Salvadó J, FABP4 predicts atherogenic dyslipidemia development. The PREDIMED study., Atherosclerosis, 2012, 222, 1, 229-234, doi: 10.1016/j.atherosclerosis.2012.02.003.

  39. Ortega-Azorín C, Sorlí JV, Asensio EM, Coltell O, Martínez-González MÁ, Salas-Salvadó J, Covas MI, Arós F, Lapetra J, Serra-Majem L, Gómez-Gracia E, Fiol M, Sáez-Tormo G, Pintó X, Muñoz MA, Ros E, Ordovás JM, Estruch R, Corella D, Associations of the FTO rs9939609 and the MC4R rs17782313 polymorphisms with type 2 diabetes are modulated by diet, being higher when adherence to the Mediterranean diet pattern is low., Cardiovasc Diabetol, 2012, 11, 137, doi: 10.1186/1475-2840-11-137.

  40. Martínez-Lapiscina EH, Clavero P, Toledo E, Estruch R, Salas-Salvadó J, San Julián B, Sanchez-Tainta A, Ros E, Valls-Pedret C, Martinez-Gonzalez MÁ, Mediterranean diet improves cognition: the PREDIMED-NAVARRA randomised trial., J. Neurol. Neurosurg. Psychiatr., 2013, 84, 12, 1318-1325, doi: 10.1136/jnnp-2012-304792.

  41. Sala-Vila A, Romero-Mamani ES, Gilabert R, Núñez I, de la Torre R, Corella D, Ruiz-Gutiérrez V, López-Sabater MC, Pintó X, Rekondo J, Martínez-González MÁ, Estruch R, Ros E, Changes in ultrasound-assessed carotid intima-media thickness and plaque with a Mediterranean diet: a substudy of the PREDIMED trial., Arterioscler. Thromb. Vasc. Biol., 2014, 34, 2, 439-445, doi: 10.1161/ATVBAHA.113.302327.

  42. Juanola-Falgarona M, Cándido-Fernández J, Salas-Salvadó J, Martínez-González MA, Estruch R, Fiol M, Arija-Val V, , , Association between serum ferritin and osteocalcin as a potential mechanism explaining the iron-induced insulin resistance., PLoS ONE, 2013, 8, 10, e76433, doi: 10.1371/journal.pone.0076433.

  43. Corella D, Sorlí JV, Estruch R, Coltell O, Ortega-Azorín C, Portolés O, Martínez-González MA, Bulló M, Fitó M, Arós F, Lapetra J, Asensio EM, Sáez GT, Serra-Majem L, Muñoz-Bravo C, Ruiz-Gutiérrez V, Fiol M, Vinyoles E, Pintó X, Richardson K, Ros E, Ordovás JM, MicroRNA-410 regulated lipoprotein lipase variant rs13702 is associated with stroke incidence and modulated by diet in the randomized controlled PREDIMED trial., Am. J. Clin. Nutr., 2014, 100, 2, 719-731, doi: 10.3945/ajcn.113.076992.

Additional files

Editorial Notes