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Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts
Open accessAbstract
BACKGROUND: Observational cohort studies and a secondary prevention trial have shown inverse associations between adherence to the Mediterranean diet and cardiovascular risk. METHODS: In a multicenter trial in Spain, we assigned 7447 participants (55 to 80 years of age, 57% women) who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was a major cardiovascular event (myocardial infarction, stroke, or death from cardiovascular causes). After a median follow-up of 4.8 years, the trial was stopped on the basis of a prespecified interim analysis. In 2013, we reported the results for the primary end point in the Journal. We subsequently identified protocol deviations, including enrollment of household members without randomization, assignment to a study group without randomization of some participants at 1 of 11 study sites, and apparent inconsistent use of randomization tables at another site. We have withdrawn our previously published report and now report revised effect estimates based on analyses that do not rely exclusively on the assumption that all the participants were randomly assigned. RESULTS: A primary end-point event occurred in 288 participants; there were 96 events in the group assigned to a Mediterranean diet with extra-virgin olive oil (3.8%), 83 in the group assigned to a Mediterranean diet with nuts (3.4%), and 109 in the control group (4.4%). In the intention-to-treat analysis including all the participants and adjusting for baseline characteristics and propensity scores, the hazard ratio was 0.69 (95% confidence interval [CI], 0.53 to 0.91) for a Mediterranean diet with extra-virgin olive oil and 0.72 (95% CI, 0.54 to 0.95) for a Mediterranean diet with nuts, as compared with the control diet. Results were similar after the omission of 1588 participants whose study-group assignments were known or suspected to have departed from the protocol. CONCLUSIONS: In this study involving persons at high cardiovascular risk, the incidence of major cardiovascular events was lower among those assigned to a Mediterranean diet supplemented with extra-virgin olive oil or nuts than among those assigned to a reduced-fat diet. (Funded by Instituto de Salud Carlos III, Spanish Ministry of Health, and others; Current Controlled Trials number, ISRCTN35739639 .).
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“Diets emphasizing whole, minimally processed foods—such as vegetables, fruits, whole grains, legumes, nuts, seeds, and lean protein sources—have been consistently associated with a reduced risk of obesity, type 2 diabetes, hypertension, and cardiovascular disease [164,165,166,167].”
From Lifestyle Medicine for Obesity in the Era of Highly Effective Anti-Obesity Treatment (2025) · cites this paper as [165]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“The Mediterranean diet, rich in olive oil, vegetables, legumes, nuts, and fish, promotes weight maintenance and cardiovascular health even without strict calorie limits [100].”
From Obesity: Clinical Impact, Pathophysiology, Complications, and Modern Innovations in Therapeutic Strategies (2025) · cites this paper as [100]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“They tend to be relatively high in unsaturated fat, particularly from extravirgin olive oil.”
From Popular dietary patterns: alignment with American Heart Association 2021 dietary guidance: a scientific statement from the American Heart Association. (2023) · cites this paper as [19]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“a Mediterranean-style eating pattern intervention enriched with olive oil or nuts significantly reduced CVD incidence in both people with and without diabetes (91).”
From Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report (2019) · cites this paper as [91]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“To date, improvements in dietary quality rather than restrictive dietary counseling have shown benefits in primary and secondary CVD prevention,98,99”
From Malnutrition and Cachexia in Inpatients With Acute Cardiac Conditions: A Scientific Statement From the American Heart Association (2026) · cites this paper as [99]
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“provided bene fi ts for cardiovascular health (76,77).”
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In the citing paper
“A healthy lifestyle is the basis to optimise health outcomes regardless of WL – increased levels of physical activity have multiple health benefits including improvement of body composition, physical function and cardiorespiratory fitness, and a balanced Mediterranean diet may be associated with cardiovascular benefits [105].”
From What is the pipeline for future medications for obesity? (2025) · cites this paper as [105]
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In the citing paper
“In a systematic review of trials of > 6 months ' duration, compared with a low-fat diet, the Mediterranean diet demonstrated greater reductions in body weight and HbA1c levels”
From Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2022) · cites this paper as [77]
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“delayed the requirement for diabetes medication”
From Management of Hyperglycemia in Type 2 Diabetes, 2022. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2022) · cites this paper as [77]
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“Studies have demonstrated that a variety of eating plans, varying in macronutrient composition, can be used effectively and safely in the short term (1-2 years) to achieve weight loss in people with diabetes.”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:Standards of Care in Diabetes—2023 (2023) · cites this paper as [120]
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
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“The Mediterranean diet, rich in fiber, polyphenols, and monounsaturated fats, exemplifies a microbiome-friendly dietary pattern. It promotes beneficial bacterial growth while reducing inflammation and metabolic disorders.”
From The Power of Environment: A Comprehensive Review of the Exposome's Role in Healthy Aging, Longevity, and Preventive Medicine-Lessons from Blue Zones and Cilento (2025) · cites this paper as [102]
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“Similarly, traditional diets such as the Okinawa diet—high in vegetables, soy, and fish—are associated with diverse gut microbiota and reduced chronic disease risk.”
From The Power of Environment: A Comprehensive Review of the Exposome's Role in Healthy Aging, Longevity, and Preventive Medicine-Lessons from Blue Zones and Cilento (2025) · cites this paper as [102]
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“In contrast, urbanized diets, antibiotic overuse, and environmental pollution contribute to declining microbial diversity and the rise of metabolic and autoimmune disorders [7,101,102,103,104,105,106,107].”
From The Power of Environment: A Comprehensive Review of the Exposome's Role in Healthy Aging, Longevity, and Preventive Medicine-Lessons from Blue Zones and Cilento (2025) · cites this paper as [102]
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In the citing paper
“However, most individuals with type 2 diabetes are asymptomatic at diagnosis, and routine screening is recommended (Box 2).14,22”
From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [22]
Experimental — accuracy not yet measuredIn the citing paper
“If this diet is supplemented with olive oil or nuts, as in the non-randomized PREvencion con Dieta MEDiterranea (PREDIMED) study in individuals at high CV risk (49% T2DM), the risk of ASCVD was reduced by 28-31%.82”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [82]
In the citing paper
“The journal's investigations led to none of the 11 test-positive papers being retracted except for one, which was subsequently republished.40,41”
From Integrity of randomized clinical trials: Performance of integrity tests and checklists requires assessment (2023) · cites this paper as [40]
In the citing paper
“The Mediterranean diet in the PREDIMED trial, which showed a 30% reduction in CVD risk, was characterized by avoidance of red meat as a protein source.36,37”
From Impact of chronic dietary red meat, white meat, or non-meat protein on trimethylamine N-oxide metabolism and renal excretion in healthy men and women (2019) · cites this paper as [37]
In the citing paper
“Monounsaturated fatty acids (MUFAs) and polyunsaturated fatty acids (PUFAs), in forms of olive oil, nuts and seeds in plant-based dietary regimens, may function as the driving force for the amelioration of glucose metabolism, insulin sensitivity, blood lipids and CVD risk, observed either in diabetic individuals [17,40,41] or in the general population [42].”
From Mediterranean diet nutrients to turn the tide against insulin resistance and related diseases (2020) · cites this paper as [41]
In the citing paper
“Efficacy studies of healthy dietary patterns have resulted in a significant reduction of risk factors.12,13,19,26,97,98”
From Popular dietary patterns: alignment with American Heart Association 2021 dietary guidance: a scientific statement from the American Heart Association. (2023) · cites this paper as [19]
In the citing paper
“The type of fats consumed is more important than total amount of fat when looking at metabolic goals and CVD risk, and it is recommended that the percentage of total calories from saturated fats should be limited (120,172,(200)(201)(202).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:Standards of Care in Diabetes—2023 (2023) · cites this paper as [120]
In the citing paper
“Multiple RCTs including people with type 2 diabetes have reported that a Mediterranean eating pattern (120,203-208) can improve both glycemic management and blood lipids.”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:Standards of Care in Diabetes—2023 (2023) · cites this paper as [120]
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Metadata
- Authors
- Estruch, R., Ros, E., Salas-Salvadó, J., Covas, M.-I., Corella, D., Arós, F., Gómez-Gracia, E., Ruiz-Gutiérrez, V., Fiol, M., Lapetra, J., Lamuela-Raventos, R. M., Serra-Majem, L., Pintó, X., Basora, J., Muñoz, M. A., Sorlí, J. V., Martínez, J. A., Fitó, M., Gea, A., Hernán, M. A., & Martínez-González, M. A.
- Affiliations
- Instituto de Salud Carlos III (ES)
- From the PREDIMED (Prevención con Dieta Mediterránea) Network (RD 06/0045) (R.E., J.S.-S., F.A., E.G.-G., V.R.-G., R.M.L.-R., L.S.-M., X.P., J.B., J.V.S., J.A.M., M.A.M.-G.) and Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición (R.E., E.R., J.S.-S., M.-I.C., D.C., F.A., M. Fiol, J.L., R.M.L.-R., L.S.-M., X.P., J.B., J.V.S., J.A.M., M. Fitó, A.G., M.A.M.-G.), Instituto de Salud Carlos III, Madrid, the Department of Internal Medicine, Hospital Clinic (R.E.), the...
- Universitat de València (ES)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-06-21
- Volume
- 378
- Issue
- 25
- Pages
- 1388-1389
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2807970930
- Semantic Scholar
- 580a209e2919f5cc97eaef2baa9bda59f3697e6b
- Cited by
- 3,616
- References
- 33
- Citations by year
- 2026: 470 · 2025: 472 · 2024: 431 · 2023: 489 · 2022: 406 · 2021: 445 · 2020: 455 · 2019: 322 · 2018: 111
- FWCI
- 317.46
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Dipòsit Digital de la Universitat de Barcelona (Universitat de Barcelona) (submittedVersion, public-domain)
- Acceda (Universidad de Las Palmas de Gran Canaria) (submittedVersion)
- DIGITAL.CSIC (Spanish National Research Council (CSIC)) (submittedVersion)
- Docusalut (Conselleria de Salut i Consum del Govern de les Illes Balears) (submittedVersion)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- Funders
- Public Health Division of the Department of Health of the Autonomous Government of Catalonia (Public Health Division of the Department of Health)
- Instituto de Salud Carlos III (CIBERobn, CP06/00100, P11/02505, PI 05/2584, PI 07/0473, PI04/0954, PI07/0240, PI07/0954, PI07/1138, PI10/01407, PI10/02658, PI11/01647, RTIC G03/140, RTIC RD06/0045)
- Departamento de Educación, Gobierno de Navarra (P27/2011)
- Generalitat Valenciana (ACOMP06109, CS2010-AP-111, CS2011-AP-042, GVACOMP2010-181, GVACOMP2011-151)
- Patient-Centered Outcomes Research Institute (ME-1503-28119)
- Ministerio de Ciencia e Innovación (AGL-2009-13906-C02, AGL2010-22319-C03)
- Centro Nacional de Investigaciones Cardiovasculares (CNIC 06/2007)
- Consejería de Salud de la Junta de Andalucía (PI0105/2007)
- Fundación Mapfre (Fundación Mapfre 2010)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
- Health Sciences › Nursing › Nutrition and Dietetics › Nuts composition and effects
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Keywords
- Mediterranean diet, extra virgin olive oil, mixed nuts, primary prevention, cardiovascular disease, major adverse cardiovascular events, myocardial infarction, stroke, cardiovascular mortality, high cardiovascular risk, dietary intervention, protocol deviations, propensity score, intention-to-treat analysis
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