6533b7d0fe1ef96bd125baa3
RESEARCH PRODUCT
Cohort Profile: Design and methods of the PREDIMED-Plus randomized trial
Lidia ÁNgeles Daimiel-ruizIsmael Alvarez-alvarezEmilio Ortega Martinez De VictoriaRocío Zamanillo CamposJessica Pérez LópezJorge Romeo-olloraAlba Marcos-delgadoVicente MartinJose Lopez-mirandaXavier Pintó SalaRamon Sagarra ÀLamoMiguel A. RubioRoberto ElosuaCristina RazquinItziar Salaverría LeteCristina BotellaJosep BasoraSebastian MasMònica BullóÁLvaro HernáezXavier Capó FiolRosa CasasHelmut SchroderJosé D. Torres PeñaMaira Bes-rastrolloMonica DomenechJoan Salvador Vila-domènechChristopher PapandreouJuan José Cabré VilaMiguel Ruiz-canelaManuela AbbateManuel MoñinoJesús Francisco García-gavilánLucía Camacho-barciaPaula CarrascoAlejandro Oncina CanovasJulia WarnbergMario Gutiérrez-bedmarCarmen Sayon-oreaLaura Forcano GamazoIñaki ZorrillaAlicia Lopez MaldonadoMercè López GrauAna Maria Ruiz-leonCristina Bouzas VelascoEmili CorbellaAina M YañezSilvia CanudasMiguel Camafort-babkowskiFernando Fernández-arandaJosé V SorlíLaura M Compañ GabucioFrancisco J. TinahonesAlicia JulibertArne AstrupLaura Torres-colladoAntoni Colom FernándezDavid BenaigesJesus Iturralde IrisoPilar Buil-cosialesOlga CastañerXavier CorbellaAna BarabashJordi Salas-salvadóMiguel-angel MuñozNancy Babio SánchezDora RomagueraAnna BoronatRafel M. PrietoPablo Ignacio Hernandez RivasDomingo Orozco-beltranGaspar MestresGracia Maria Quintana-navarroM. Dolores ZomeñoJosé Carlos Fernández-garcíaLucas Tojal SierraIván Abellán CanoJosep VidalJoan SabateInmaculada Bautista-castañoErnest VinyolesSandra González PalaciosAlmudena Sanchez VillegasSusana Gonzalez TorrenteAlbert Salas-huetosAurora Bueno-cavanillasM Rosa Bernal LopezMacarena Torrego-ellacuríaNuria Estañ CapellMariam De La PozaJaume MarrugatGuillermo-t. SáezJesús VioqueBlanca Riquelme GallegoAida Cuenca RoyoLaura Gallardo Alfarosubject
MaleResearch designobesitymedicine.medical_specialtyTime FactorsEpidemiologyHealth StatusMEDLINE030204 cardiovascular system & hematologyDiet MediterraneanRisk Assessmentlaw.invention03 medical and health sciences0302 clinical medicineRandomized controlled trialRisk FactorslawSurveys and QuestionnairesmedicineHumansMulticenter Studies as Topic030212 general & internal medicineAgedRandomized Controlled Trials as TopicEvidence-Based Medicinebusiness.industryGeneral MedicineMiddle AgedPredimedDietCardiovascular DiseasesResearch DesignSpainSample size determinationSample SizeCohortPhysical therapyFemalepredimed trialRisk assessmentbusinessRisk Reduction Behaviordescription
The PREDIMED (in Spanish: PREvención con DIeta MEDiterránea) primary prevention trial1–3 reported in 2013 that long-term adherence to an energy-unrestricted Mediterranean diet (MedDiet), supplemented with either extra-virgin olive oil (EVOO) or nuts, reduced cardiovascular disease (CVD). PREDIMED showed a 30% relative reduction in the composite cardiovascular primary endpoint (stroke, myocardial infarction or cardiovascular death).2,,3 However, the PREDIMED trial tested only the composition of the diet, but did not test other lifestyle interventions (i.e. energy reduction, increased physical activity (PA) and behavioural modification) frequently applied in the context of the current unprecedented obesity pandemic.4,,5 With the exception of the null results of the Look-AHEAD trial,6 and the successful results of the EXERDIET-HTA study that found improvements in blood pressure, cardio-respiratory fitness and body composition (though they encouraged adherence to an hypocaloric DASH diet, instead of a Mediterranean diet),7 lifestyle interventions including such components have never been tested in long-term randomized trials using hard cardiovascular events as endpoints.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2019-04-01 | International Journal of Epidemiology |