Evidence map›Paper›PMID 23432189›Full record

Trial reportThe New England journal of medicine2013

Primary prevention of cardiovascular disease with a Mediterranean diet.

Ramón Estruch, Emilio Ros, Jordi Salas-Salvadó, Maria-Isabel Covas, Dolores Corella, Fernando Arós, Enrique Gómez-Gracia, Valentina Ruiz-Gutiérrez, Miquel Fiol, José Lapetra and 9 more

RetractedErratum issued 11 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled TrialRetracted Publication
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to 11 registered trials, which are not on this map. Cited by 588 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
588citing papers in PubMed, 17 pooled it
571.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02910154 nacompletedstarted 2016, after this paper: background citation

Comprehensive Treatment of Angina in Women With Microvascular Dysfunction - a Proof of Concept Study of the iPower Cohort

Ran2016Enrolled62Registered outcomes9Posted comparisons0ConditionsAngina Pectoris, Coronary Microvascular DiseaseArmsdiet, Medication (with statin and ACE-inhibition), training
PMID 19878986PMID 10675425PMID 11788217PMID 11991214PMID 12147179PMID 12914662PMID 13394341PMID 15007010PMID 15020531PMID 15671433PMID 16368303PMID 16458167other papers from this trial
Open the trial in the graph
NCT02016014 nacompletednot on this mapstarted 2014, after this paper: background citation

Effectiveness of the Use of a Mobile Tool Added to a Standard Intervention in Improving Lifestyles in Adults

TypeinterventionalSponsorInstituto de Investigación Biomédica de SalamancaRan2014 to 2016Enrolled833ConditionsHealthy Subjects Without Cardiovascular DiseaseArmsSmartphone with APP, Counseling on lifestyles
NCT02610270 early_phase1completednot on this mapstarted 2014, after this paper: background citation

Erythrocyte Omega-3 Fatty Acid Content in Elite Athletes in Response to Omega-3 Supplementation: A Dose-Response

TypeinterventionalSponsorCentre d'Alt RendimentRan2014 to 2015Enrolled24ConditionsHealthyArms2 Gums, 3 Gums
NCT02837666 nacompletednot on this mapstarted 2017, after this paper: background citation

Independent and Synergistic Effect of Spirulina Maxima With Exercise on General Fitness, Lipid Profile and Antioxidant Capacity in Overweight and Obese Subjects

TypeinterventionalSponsorUniversidad Autonoma de Ciudad JuarezRan2017 to 2017Enrolled52ConditionsCardiovascular DiseasesArmsSupplementation with Spirulina maxima, Washout, Supplementation with placebo, Isoenergetic diet, Exercise program
NCT03053843 naunknown statusnot on this mapstarted 2017, after this paper: background citation

Randomized Trial of Mediterranean Diet Plus Extravirgin Olive Oil in the Prevention of Recurrent Arrhythmias. The PREDIMAR (PREvención Con DIeta Mediterránea de Arritmias Recurrentes) Trial

TypeinterventionalSponsorFundación de investigación HMRan2017 to 2022Enrolled720ConditionsAtrial Fibrillation, Atrial ArrhythmiaArmsMediterranean diet plus extra virgin olive oil
NCT03104712 nacompletednot on this mapstarted 2017, after this paper: background citation

The Importance of Glycemic Index on Postprandial Glycemia and Insulinemia in the Context of the Addition of Fat to Carbohydrate Foods: A Randomized Controlled Trial on Spaghetti Versus Rice as Mixed Meals

TypeinterventionalSponsorUniversity of ParmaRan2017 to 2018Enrolled13ConditionsDietary ModificationArmsGlucose #1, Glucose #2, Glucose #3, Spaghetti, Rice
NCT04025281 nacompletednot on this mapstarted 2019, after this paper: background citation

Post-prandial Effects of Extra Virgin Olive Oil on Endothelial Function in Adults at Risk for Type 2 Diabetes: A Randomized Crossover Controlled Trial

TypeinterventionalSponsorGriffin HospitalRan2019 to 2019Enrolled20ConditionsType 2 DiabetesArmsExtra Virgin Olive Oil, Refined Olive Oil
NCT04077216 nacompletednot on this mapstarted 2018, after this paper: background citation

Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus: A Randomized Controlled Trial

TypeinterventionalSponsorMakati Medical CenterRan2018 to 2018Enrolled14ConditionsDiabetes Mellitus, Type 2ArmsExtra Virgin Olive Oil (EVOO)
NCT04658875 nacompletednot on this mapstarted 2022, after this paper: background citation

Effect of a Systematic Physical Exercise Program and Spirulina Maxima Supplementation on the Body Composition, Physical Function and Blood Lipid Profile in Sedentary Older Adults With Excess Weight

TypeinterventionalSponsorUniversidad Autonoma de Baja CaliforniaRan2022 to 2024Enrolled12ConditionsOverweight and ObesityArmsSpirulina maxima supplementation, Wash-out, Placebo supplementation, Isoenergetic diet, Systematic physical exercise program
NCT05745194 narecruitingnot on this mapstarted 2023, after this paper: background citation

Nutritional Counselling Promoting Adherence to the Mediterranean Diet as Adjuvant in the Treatment of Major Depressive Disorder: A Randomized Open Controlled Trial Study

TypeinterventionalSponsorAssociacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERARan2023 to 2025Enrolled190ConditionsMajor Depressive Disorder - MDDArmsPromotion of adherence to the MedDiet
NCT06057324 naenrolling by invitationnot on this mapstarted 2023, after this paper: background citation

Switching Mediterranean Consumers to Mediterranean Sustainable Healthy Dietary Patterns by Combining Digital Interactive Tools with Targeted Educational Material and Sustainable Snacks

TypeinterventionalSponsorFundació EurecatRan2023 to 2025Enrolled480ConditionsHealthy Subjects, Behavior, Health, FamilyArmsAI-based Apps, Mediterranean-based diet toolkit and activities, Healthy plant-based snacks, AI-based Apps + Mediterranean-based diet toolkit and activities, AI-based Apps + Healthy plant-based snacks
3 · Its place in the literature

Who cites it

588 citing papers in PubMed, 17 syntheses or guidelines pooled it, 4,206 citations in OpenAlex.

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  11. Reduction in saturated fat intake for cardiovascular disease.The Cochrane database of systematic reviews · 2020
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  12. Reduction in saturated fat intake for cardiovascular disease.The Cochrane database of systematic reviews · 2020
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  13. Dietary interventions for multiple sclerosis-related outcomes.The Cochrane database of systematic reviews · 2020
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  14. Mediterranean Diet and its Benefits on Health and Mental Health: A Literature Review.Clinical practice and epidemiology in mental health : CP & EMH · 2020
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528 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 1 institution in 1 country.

Ramón EstruchCentro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, Instituto de Salud Carlos III, Madrid, Spain. restruch@clinic.ub.es
Emilio Ros
Jordi Salas-Salvadó
Maria-Isabel Covas
Dolores Corella
Fernando Arós
Enrique Gómez-Gracia
Valentina Ruiz-Gutiérrez
Miquel Fiol
José Lapetra
Rosa Maria Lamuela-Raventos
Lluís Serra-Majem
Xavier Pintó
Josep Basora
Miguel Angel Muñoz
José V Sorlí
José Alfredo Martínez
Miguel Angel Martínez-González
PREDIMED Study Investigators
Spanish Biomedical Research Centre in Physiopathology of Obesity and Nutrition · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundObservational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events.

methodsIn a multicenter trial in Spain, we randomly assigned participants 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 individual and group 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 the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years.

resultsA total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported.

conclusionsAmong persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. (Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com number, ISRCTN35739639.).

Indexed as

Diet, MediterraneanNutsPlant OilsPrimary PreventionAgedAged, 80 and overCardiovascular DiseasesDietary SupplementsDiet, Fat-RestrictedFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMultivariate AnalysisMyocardial InfarctionOlive OilPlant Oils

Identifiers

PMID23432189
OpenAlexW2166000498

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 5 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.