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Effect of a Nutritional and Behavioral Intervention on Energy-Reduced Mediterranean Diet Adherence Among Patients With Metabolic SyndromeInterim Analysis of the PREDIMED-Plus Randomized Clinical Trial

Educational Objective
To understand the importance of adherence to a high-quality diet.
1 Credit CME
Key Points

Question  What is the effect of a nutritional and behavioral intervention focused on encouraging an energy-reduced Mediterranean diet and physical activity on the dietary pattern of participants after 12 months?

Findings  In this preliminary analysis of an ongoing randomized clinical trial involving 6874 participants, an intervention focused on encouraging an energy-reduced Mediterranean diet and promoting physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significant increase in a measure of diet adherence, the 17-item energy-reduced Mediterranean diet score, at 12 months (4.7 points vs 2.5 points; score range, 0-17; minimal clinically important difference, 1 point).

Meaning  A nutritional and behavioral intervention focused on encouraging an energy-reduced Mediterranean diet and physical activity led to a significant improvement in a measure of diet adherence at 12 months. Further evaluation of the effects on long-term cardiovascular and other health outcomes is needed.

Abstract

Importance  High-quality dietary patterns may help prevent chronic disease, but limited data exist from randomized trials about the effects of nutritional and behavioral interventions on dietary changes.

Objective  To assess the effect of a nutritional and physical activity education program on dietary quality.

Design, Setting, and Participants  Preliminary exploratory interim analysis of an ongoing randomized trial. In 23 research centers in Spain, 6874 men and women aged 55 to 75 years with metabolic syndrome and no cardiovascular disease were enrolled in the trial between September 2013 and December 2016, with final data collection in March 2019.

Interventions  Participants were randomized to an intervention group that encouraged an energy-reduced Mediterranean diet, promoted physical activity, and provided behavioral support (n = 3406) or to a control group that encouraged an energy-unrestricted Mediterranean diet (n = 3468). All participants received allotments of extra-virgin olive oil (1 L/mo) and nuts (125 g/mo) for free.

Main Outcomes and Measures  The primary outcome was 12-month change in adherence based on the energy-reduced Mediterranean diet (er-MedDiet) score (range, 0-17; higher scores indicate greater adherence; minimal clinically important difference, 1 point).

Results  Among 6874 randomized participants (mean [SD] age, 65.0 [4.9] years; 3406 [52%] men), 6583 (96%) completed the 12-month follow-up and were included in the main analysis. The mean (SD) er-MedDiet score was 8.5 (2.6) at baseline and 13.2 (2.7) at 12 months in the intervention group (increase, 4.7 [95% CI, 4.6-4.8]) and 8.6 (2.7) at baseline and 11.1 (2.8) at 12 months in the control group (increase, 2.5 [95% CI, 2.3-2.6]) (between-group difference, 2.2 [95% CI, 2.1-2.4]; P < .001).

Conclusions and Relevance  In this preliminary analysis of an ongoing trial, an intervention that encouraged an energy-reduced Mediterranean diet and physical activity, compared with advice to follow an energy-unrestricted Mediterranean diet, resulted in a significantly greater increase in diet adherence after 12 months. Further evaluation of long-term cardiovascular effects is needed.

Trial Registration  isrctn.com Identifier: ISRCTN89898870

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Article Information

Corresponding Authors: Miguel A. Martínez-González, MD, Department of Preventive Medicine and Public Health, University of Navarra, C/Irunlarrea, 1, 31080 Pamplona, Navarra, Spain (mamartinez@unav.es); Jordi Salas-Salvadó, MD, Human Nutrition Unit, Faculty of Medicine and Health Sciences, Universitat Rovira i Virgili, C/ Sant Llorenç, 21, 43201 Reus, Tarragona, Spain (jordi.salas@urv.cat).

Accepted for Publication: August 23, 2019.

Author Contributions: Drs Martínez-González and Salas-Salvadó had full access to all of the data in the study, take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Martínez-González and Salas-Salvadó equally contributed as co–senior authors.

Concept and design: Corella, Fitó, Wärnberg, Martínez, Serra-Majem, Estruch, Pintó, Bueno-Cavanillas, Delgado-Rodriguez, Daimiel, Vidal, Sorlí, Gómez-Gracia, Basora, Toledo, Díaz-López, Salas-Salvadó, Martínez-González.

Acquisition, analysis, or interpretation of data: Sayon-Orea, Razquin, Bulló, Corella, Fitó, Romaguera, Vioque, Alonso-Gomez, Wärnberg, Martínez, Serra-Majem, Estruch, Tinahones, Lapetra, Pintó, Tur, López-Miranda, Bueno-Cavanillas, Delgado-Rodriguez, Matía-Martín, Daimiel, Martín-Sánchez, Vidal, Vázquez, Ros, Ruiz-Canela, Sorlí, Castañer, Fiol, Navarrete-Muñoz, Arós, Gómez-Gracia, Zulet, Sánchez-Villegas, Casas, Bernal-López, Santos-Lozano, Corbella, Bouzas, García-Arellano, Asensio, Schröder, Moñino, García de la Hera, Tojal-Sierra, Toledo, Díaz-López, Goday, Salas-Salvadó, Martínez-González.

Drafting of the manuscript: Sayon-Orea, Fitó, Alonso-Gomez, Martínez, Tinahones, Pintó, Vidal, Bernal-López, Salas-Salvadó, Martínez-González.

Critical revision of the manuscript for important intellectual content: Razquin, Bulló, Corella, Fitó, Romaguera, Vioque, Wärnberg, Martínez, Serra-Majem, Estruch, Tinahones, Lapetra, Pintó, Tur, López-Miranda, Bueno-Cavanillas, Delgado-Rodriguez, Matía-Martín, Daimiel, Martín-Sánchez, Vidal, Vázquez, Ros, Ruiz-Canela, Sorlí, Castañer, Fiol, Navarrete-Muñoz, Arós, Gómez-Gracia, Zulet, Sánchez-Villegas, Casas, Bernal-López, Santos-Lozano, Corbella, Bouzas, García-Arellano, Basora, Asensio, Schröder, Moñino, García de la Hera, Tojal-Sierra, Toledo, Díaz-López, Goday, Salas-Salvadó.

Statistical analysis: Sayon-Orea, Razquin, Martínez, Pintó, Bueno-Cavanillas, Gómez-Gracia, Corbella, Toledo, Díaz-López, Martínez-González.

Obtained funding: Corella, Romaguera, Vioque, Wärnberg, Martínez, Serra-Majem, Estruch, Tinahones, Pintó, Tur, López-Miranda, Bueno-Cavanillas, Delgado-Rodriguez, Daimiel, Martín-Sánchez, Vidal, Ros, Sorlí, Fiol, Arós, Bernal-López, Corbella, Basora, Toledo, Díaz-López, Salas-Salvadó, Martínez-González.

Administrative, technical, or material support: Corella, Romaguera, Serra-Majem, Estruch, Pintó, Tur, López-Miranda, Delgado-Rodriguez, Fiol, Navarrete-Muñoz, Casas, Corbella, Bouzas, García-Arellano, Basora, Moñino, Díaz-López, Salas-Salvadó, Martínez-González.

Supervision: Bulló, Corella, Fitó, Vioque, Martínez, Serra-Majem, Tinahones, Pintó, Tur, López-Miranda, Bueno-Cavanillas, Matía-Martín, Daimiel, Vidal, Sorlí, Gómez-Gracia, Zulet, Sánchez-Villegas, Basora, Goday, Salas-Salvadó, Martínez-González.

Conflict of Interest Disclosures: Dr Ros reported receiving grants, personal fees, and nonfinancial support from the California Walnut Commission during the conduct of the study and grants, personal fees, nonfinancial support from Alexion; grants from Amgen and Pfizer; grants and personal fees from Sanofi Aventis; personal fees and nonfinancial support from Ferrer International, Danone, and Merck Sharp & Dohme; and personal fees from Amarin outside the submitted work. Dr Corella reported receiving grants from Instituto de Salud Carlos III during the conduct of the study. Dr Romaguera reported receiving grants from Instituto de Salud Carlos III, Spanish government during the conduct of the study and grants from Fundación AstraZeneca outside the submitted work. Dr Estruch reported receiving grants from Instituto de Salud Carlos III and olive oil for the trial from Fundacion Patrimonio Comunal Olivarero \during the conduct of the study and personal fees from Brewers of Europe, Fundación Cerveza y Salud, Interprofesional del Aceite de Oliva, Instituto Cervantes, Instituto Cervantes, Pernaud Richar, Fundación Dieta Mediterránea, Wine and Culinary International Forum; nonfinancial support from Sociedad Española de Nutrición and Fundación Bosch y Gimpera; and grants from Uriach Laboratories outside the submitted work. Dr López-Miranda reported receiving grants from Fondo de Investigaciones Sanitarias, Instituto de Salud Carlos III during the conduct of the study. Dr Matía-Martín reported receiving grants from Instituto de Salud Carlos III during the conduct of the study and personal fees from Organización Interprofesional Láctea outside the submitted work. Dr Vidal reported receiving grants from Instituto de Salud Carlos III during the conduct of the study. Dr Fiol reported receiving grants from Instituto de Salud Carlos III, Spanish government during the conduct of the study. Dr Arós reported receiving grants from Instituto de Salud Carlos III, Fondo de Investigaciones Sanitarias (Spain) and from CIBEROBN, Instituto de Salud Carlos III (Spain) during the conduct of the study. Dr Moñino reported receiving grants from Instituto de Salud Carlos III, Spanish government during the conduct of the study. Dr Bouzas reported received a Fernando Tarongí Bauzà grant. Dr Salas-Salvado reported receiving research support from the Instituto de Salud Carlos III, Ministerio de Educación y Ciencia, Departament de Salut Pública de la Generalitat de Catalunya, the European Commission, the California Walnut Commission, Patrimonio Comunal Olivarero, La Morella Nuts, and Borges S.A; receiving consulting fees or travel expenses from Danone, California Walnut Commission, Eroski Foundation, Instituto Danone, Nestle, and Abbott Laboratories, receiving nonfinancial support from Hojiblanca, Patrimonio Comunal Olivarero, and Almond Board of California; serving on the board of and receiving grant support through his institution from the International Nut and Dried Foundation and the Eroski Foundation; and grants and personal fees from Instituto Danone. No other disclosures were reported.

Funding/Support: This work was supported by the European Research Council (Advanced Research grant 2014-2019; agreement #340918; granted to Dr Martínez-González); the official Spanish institutions for funding scientific biomedical research, CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn) and Instituto de Salud Carlos III (ISCIII) through the Fondo de Investigación para la Salud (FIS), which is cofunded by the European Regional Development Fund (coordinated FIS projects led by Drs Salas-Salvadó and Vidal, including the following projects: PI13/00673, PI13/00492, PI13/00272, PI13/01123, PI13/00462, PI13/00233, PI13/02184, PI13/00728, PI13/01090, PI13/01056, PI14/01722, PI14/00636, PI14/00618, PI14/00696, PI14/01206, PI14/01919, PI14/00853, PI14/01374, PI14/00972, PI14/00728, PI14/01471, PI16/00473, PI16/00662, PI16/01873, PI16/01094, PI16/00501, PI16/00533, PI16/00381, PI16/00366, PI16/01522, PI16/01120, PI17/00764, PI17/01183, PI17/00855, PI17/01347, PI17/00525, PI17/01827, PI17/00532, PI17/00215, PI17/01441, PI17/00508, PI17/01732, PI17/00926, PI19/00957, PI19/00386, PI19/00309, PI19/01032, PI19/00576, PI19/00017, PI19/01226, PI19/00781, PI19/01560, PI19/01332) and the Especial Action Project “Implementación y evaluación de una intervención intensivasobre la actividad física Cohorte PREDIMED-Plus” (Dr Salas-Salvadó); the Recercaixa (grant number 2013ACUP00194) (Dr Salas-Salvadó); the SEMERGEN grant; International Nut and Dried Fruit Council–FESNAD (Long-term effects of an energy-restricted Mediterranean diet on mortality and cardiovascular disease 2014 –2015; No. 201302) (Dr Martinez-Gonzalez); the AstraZeneca Young Investigators Award in Category of Obesity and T2D 2017 (Dr Romaguera); grants from the Consejería de Salud de la Junta de Andalucía (PI0458/2013; PS0358/2016; PI0137/2018), the PROMETEO/2017/017 grant from the Generalitat Valenciana, the SEMERGEN grant; grant of support to research groups 35/2011 (Balearic Islands Gov; FEDER funds) (Drs Tur and Bouzas).

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Information: Nonauthor collaborators who contributed to data collection and assistance: P. Buil-Cosiales, Z. Vázquez, A. Sanchez Tainta, B. SanJulian Aranguren, E. Goñi, I. Barrientos, M. Canales, M. Arias, E. Lorenzo, M.J. Cobo, A. Rico, F.J. Basterra Gortari, I. Zazpe, M. Bes-Rastrollo, J. Diez-Espino, O. Lecea-Juarez, J. Carlos Cenoz-Osinaga, J. Bartolome-Resano, E. Lozano-Oloriz, B. Cano-Valles, S. Eguaras, E. Pascual Roquet-Jalmar, I. Galilea-Zabalza, H. Lancova, R. Ramallal, M.L. Garcia-Perez, V. Estremera-Urabayen, M.J. Ariz-Arnedo, C. Hijos-Larraz, C. Fernandez Alfaro, B. Iñigo-Martinez, R. Villanueva Moreno, S. Martin-Almendros, L. Barandiaran-Bengoetxea, C. Fuertes-Goñi, A. Lezaun-Indurain, M.J. Guruchaga-Arcelus, O. Olmedo-Cruz, B. Iñigo-Martínez, L. Escriche-Erviti, R. Ansorena-Ros, R. Sanmatin-Zabaleta, J. Apalategi-Lasa, J. Villanueva-Telleria, M.M. Hernández-Espinosa, I. Arroyo-Bergera, L. Herrera-Valdez, L. Dorronsoro-Dorronsoro (Department of Preventive Medicine and Public Health, University of Navarra-Navarra Institute for Health Research (IdiSNA), Osasunbidea-SNS, Pamplona, Spain); R. Pedret Llaberia, R. Gonzalez, R. Sagarra Álamo, F. París Palleja, J. Balsells, J.M. Roca, T. Basora Gallisa, J. Vizcaino, P. Llobet Alpizarte, C. Anguera Perpiñá, M. Llauradó Vernet, C. Caballero, M. Garcia Barco, M.D. Morán Martínez, J. García Rosselló, A. Del Pozo, C. Poblet Calaf, P. Arcelin Zabal, X. Floresví, M. Ciutat Benet, A. Palau Galindo, J.J. Cabré Vila, F. Dolz Andrés, M. Soler, M. Gracia Vidal, J. Vilalta J. Boj Casajuana, M. Ricard, F. Saiz, A. Isach, M. Sanchez Marin Martinez, E. Granado Font, C, Lucena Luque, C. Mestres Sola, M. Bulló, N. Babio, N. Becerra-Tomás, G. Mestres, J. Basora, G. Mena-Sánchez, L. Barrubés Piñol, M. Gil Segura, C. Papandreou, N. Rosique-Esteban, S. Chig, I. Abellán Cano, V. Ruiz García, A. Salas-Huetos, I. Paz-Graniel, L. Sánchez Niembro, P. Hernandez-Alonso, S. Canudas, L. Camacho-Barcia, J. García-Gavilán, A. Díaz-López(Rovira i Virgili University, Department of Biochemistry and Biotechnology, Human Nutrition Unit, University Hospital of Sant Joan de Reus, Pere Virgili Institute for Health Research, Reus, Spain); J.I. González, O. Portolés, R. Fernández-Carrión, C. Ortega-Azorín, R. Barragán, E.M. Asensio, O. Coltell, C. Sáiz, R. Osma, E. Férriz, I. González-Monje, F. Giménez-Fernández, L. Quiles, P. Carrasco, P. Guillem Saiz, A. Carratalá-Calvo, C. Valero-Barceló, F. Antón, C. Mir, S. Sánchez-Navarro, J. Navas, I. González-Gallego, L. Bort-Llorca, L. Pérez-Ollero, M. Giner-Valero, R. Monfort-Sáez, J. Nadal-Sayol, V. Pascual-Fuster, M. Martínez-Pérez, C. Riera, M.V. Belda, A. Medina, E. Miralles, M.J. Ramírez-Esplugues, M. Rojo-Furió, G. Mattingley, M.A. Delgado, M.A. Pages, Y. Riofrío, L. Abuomar, N. Blasco-Lafarga, R. Tosca, L. Lizán, A.M. Valcarce, M.D. Medina, R. Martínez-Lacruz, S. de Valcárcel, N. Tormo, O. Felipe-Román, S. Lafuente, E.I. Navío, G. Aldana, J.V. Crespo, J.L. Llosa, L. González-García, R. Raga-Marí (Department of Preventive Medicine, University of Valencia, University Jaume I, Conselleria de Sanitat de la Generalitat Valenciana, Valencia, Spain); M.A. Muñoz; M.D. Zomeño, A. Hernaéz, L. Torres, M. Quifer, R. Llimona, G Freixer, A. Pérez, M. Farràs, R. Elosua, J. Vila, I. Subirana, S. Pérez, J.J. Chillaron Jordan, J.A. Flores Lerroux, D. Benaiges Boix, Llauradó G, M. Farré, E. Menoyo, D. Muñoz-Aguayo, S. Gaixas, G. Blanchart, A. Sanllorente, M. Soria, J. Valussi, A. Cuenca, L. Forcano, A. Pastor, A. Boronat, S. Tello, M. Cabañero, L. Franco, H. Schröder, R. De la Torre, C. Medrano, J. Bayó, M.T. García, V. Robledo, P. Babi, E. Canals, N. Soldevila, L. Carrés, C. Roca, M.S. Comas, G. Gasulla, X. Herraiz, A. Martínez, E. Vinyoles, J.M. Verdú, M. Masague Aguade, E. Baltasar Massip, M. Lopez Grau, M. Mengual, V. Moldon, M. Vila Vergaz, R. Cabanes Gómez, R. Ciurana, M. Gili Riu, A. Palomeras Vidal, F Peñas A. Raya, M.A. Sebastian, M. Valls (Cardiovascular Risk and Nutrition Research Group, Hospital del Mar Medical Research Institute, Barcelona. Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain); S. González Palacios, L. Torres Collado, L. Compañ Gabucio, A. Oncina Canovas, L. Notario-Barandiaran, D. Orozco Beltran, S. Pertusa Martínez, A. Asensio, I. Candela García, J. Manuel Zazo, C. Gisbert Sellés, N. Fernández Brufal, J. Román Maciá, C. Sánchez Botella, M. García Muñoz, C. Barceló, M.C. Altozano Rodado, N. Iranzo García, M.C. Martínez Vergara, M.A. Sempere Pascual, S.J. Miralles Gisbert, A. González Botella, C.M. López García, R. Valls Enguix, N. Gómez Bellvert, I. López Aguilera, R. Lloret Macián, A. Pastor Morell, E. Alonso Bartolomé, J.J. Ballester Baixauli, M.T. Cano Sánchez, B.E. Ayús Rojo, E.P. Cases Pérez, C. Tercero Maciá, L.A. Mira Castejón, I.A. García García, M. Jordá Ballesta, C. Pastor Polo, E. Puig Agulló, M. Damaj Hamieh, V. Martínez Avilés, M.A. Belmar Bueno, M.V. Hernándis Marsán (Nutritional Epidemiology Unit, Miguel Hernandez University, ISABIAL-FISABIO, Alicante, Spain); A. Colom, J. Konieczna, M. Morey, R. Zamanillo, A.M. Galmés, V. Pereira, M.A. Martín, A. Yáñez, J. Llobera, J. Ripoll, R. Prieto, F. Grases, A. Costa, C. Fernández-Palomeque, E. Fortuny, M. Noris, S. Munuera, F. Tomás, F. Fiol, A. Jover, J.M. Janer, C. Vallespir, I. Mattei, N. Feuerbach, M. del Mar Sureda, S. Vega, L. Quintana, A. Fiol, M. Amador, S. González, J. Coll, A. Moyá (Hospital Son Espases and Institute for Health Research Illes Balears, Palma de Mallorca, Spain); I. Abete, I. Cantero, C. Cristobo, I. Ibero-Baraibar, J. Ágreda Martínez, M.D. Lezáun Burgui, N. Goñi Ruiz, R. Bartolomé Resano, E. Cano Cáceres, T. Elcarte López, E. Echarte Osacain, B. Pérez Sanz, I. Blanco Platero, S.A. Andueza Azcárate, A. Gimeno Aznar, E. Ursúa Sesma, B. Ojeda Bilbao, J. Martinez Jarauta, L. Ugalde Sarasa, B. Rípodas Echarte, M.V. Güeto Rubio (Department of Nutrition, Food Sciences, and Physiology, Center for Nutrition Research, University of Navarra, Osasunbidea-SNS, Pamplona, Spain); F.J. Barón-López, J.C. Fernández García, N. Pérez-Farinós, N. Moreno-Morales, M. del C. Rodríguez-Martínez, J. Pérez-López, J.C. Benavente-Marín, E. Crespo Oliva, E. Contreras Fernández, F.J. Carmona González, R. Carabaño Moral, S. Torres Moreno, M.V. Martín Ruíz, M. Alcalá Cornide, V. Fuentes Gómez (Department of Nursing, School of Health Sciences, Málaga, Spain); A. Garcia-Rios, J. Criado García, A.I. Jiménez Morales, N. Delgado Casado, A. Ortiz Morales, J.D. Torres Peña, F.J. Gómez Delgado, F. Rodríguez Cantalejo, J. Caballero Villaraso, J.F. Alcalá, P.J. Peña Orihuela, G. Quintana Navarro (Lipids and Atherosclerosis Unit, Department of Internal Medicine, Maimonides Biomedical Research Institute of Cordoba, Reina Sofia University Hospital, University of Cordoba, Cordoba, Spain); M. Domenech, C. Viñas, S. Castro-Barquero, A.M. Ruiz-León, M. Sadurní, G. Frontana, P. Villanueva, M. Gual, R. Soriano, M. Camafort, C. Sierra, E. Sacanella, A. Sala-Vila, J. M. Cots, I. Sarroca, M. García, N. Bermúdez, A. Pérez, I. Duaso, A. de la Arada, R. Hernández, C. Simón, M.A. de la Poza, I. Gil, M. Vila, C. Iglesias, N. Assens, M. Amatller, LL. Rams, T. Benet, G. Fernández, J. Teruel, A. Azorin, M. Cubells, D. López, J.M. Llovet, M.L. Gómez, P. Climente, L. de Paula, J. Soto, C. Carbonell, C. Llor, X. Abat, A. Cama, M. Fortuny, C. Domingo, A. I. Liberal, T. Martínez, E. Yañez, M. J. Nieto, A. Pérez, E. Lloret, C. Carrazoni, A. M. Belles, C. Olmos, M. Ramentol, M. J. Capell, I. Giner, A. Muñoz, R. Martín, E. Moron, A. Bonillo, G. Sánchez, C. Calbó, J. Pous, M. Massip, Y. García, M.C. Massagué, R. Ibañez, J. Llaona, T. Vidal, N. Vizcay, E. Segura, C. Galindo, M. Moreno, M. Caubet, J. Altirriba, G. Fluxà, P. Toribio, E. Torrent, J. J. Anton, A. Viaplana, G. Vieytes, N. Duch, A. Pereira, M. A. Moreno, A. Pérez, E. Sant, J. Gené, H. Calvillo, F. Pont, M. Puig, M. Casasayas, A. Garrich, E. Senar, A. Martínez, I. Boix, E. Sequeira, V. Aragunde, S. Riera, M. Salgado, M. Fuentes, E. Martín, A. Ubieto, F. Pallarés, C. Sala, A. Abilla, S. Moreno, E. Mayor, T. Colom, A. Gaspar, A. Gómez, L. Palacios, R. Garrigosa (Department of Internal Medicine, IDIBAPS, Hospital Clínic, University of Barcelona, Barcelona, Spain); L. García Molina, B. Riquelme Gallego, N. Cano Ibañez, A. Maldonado Calvo, A. López Maldonado, E.M. Garrido, A. Baena Dominguez, F. García Jiménez, E. Thomas Carazo, A. Jesús Turnes González, F. González Jiménez, F. Padilla Ruiz, J. Machado Santiago, M.D. Martínez Bellón, A. Pueyos Sánchez, L. Arribas Mir, R. Rodríguez Tapioles, F. Dorador Atienza, L. Baena Camus, C. Osorio Martos, D. Rueda Lozano, M. López Alcázar, F. Ramos Díaz, M. Cruz Rosales Sierra, P. Alguacil Cubero, A. López Rodriguez, F. Guerrero García, J. Tormo Molina, F. Ruiz Rodríguez (Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain); J. Rekondo, I. Salaverria, M.C. Belló, A. Loma-Osorio, P. Bruyel, L. Goicolea, C. Sorto, A. Casi Casanellas, M.L. Arnal Otero, J. Ortueta Martínez De Arbulo, J. Vinagre Morgado, J. Romeo Ollora, J. Urraca, M.I. Sarriegui Carrera, F.J. Toribio, E. Magán, A. Rodríguez, S. Castro Madrid, M.T. Gómez Merino, M. Rodríguez Jiménez, M. Gutiérrez Jodra, B. López Alonso, J. Iturralde Iriso, C. Pascual Romero, A. Izquierdo De La Guerra (University Hospital Araba, Vitoria, Spain); M. Abbate, E. Angullo, E. Argelich, M.M. Bibiloni, X. Capó, S. Carreres, L. Gallardo, J.M. Gámez, B. García, C. García, A. Julibert, C. Gómez, I. Llompart, A. Martorell, C.M. Mascaró, D. Mateos, M, Monserrat, S. Montemayor, A. Pons, A. Pouso, J. Ramos, V. Ramos, T. Ripoll, T. Rodríguez, L. Sanz, A. Sureda, S. Tejada, L. Ugarriza (Research Group on Community Nutrition & Oxidative Stress, University of Balearic Islands, Palma de Mallorca, Spain); M.R. Bernal López, M. Macías González, J. Ruiz Nava, J.C. Fernández García, A. Muñoz Garach, A. Vilches Pérez, A. González Banderas, J. Alcaide Torres, A. Vargas Candela, M. León Fernández, R. Hernández Robles, S. Santamaría Fernández, J.M. Marín, S. Valdés Hernández, J.C. Villalobos, A. Ortiz (Virgen de la Victoria Hospital, University of Málaga, Málaga, Spain); J. Álvarez-Pérez, E.M. Díaz Benítez, F. Díaz-Collado, J. Pérez-Cabrera, L.T. Casañas-Quintana, R.B. García-Guerra, I. Bautista-Castaño, C. Ruano-Rodríguez, F. Sarmiento de la Fe, J.A. García-Pastor, B. Macías-Gutiérrez, I. Falcón-Sanabria, C. Simón-García, A.J. Santana-Santana, J.B. Álvarez-Álvarez, B.V. Díaz-González, J.M. Castillo Anzalas, R.E. Sosa-Also, J. Medina-Ponce (University of Las Palmas de Gran Canaria, Las Palmas, Spain); S. Abajo Olea, A. Adlbi Sibai, A. Aguado Arconada, L. Álvarez, E. Carriedo Ule, M. Escobar Fernández, J.I. Ferradal García, J.P. Fernández Vázquez, M. García González, C. González Donquiles, C. González Quintana, F. González Rivero, M. Lavinia Popescu, J.I. López Gil, J. López de la Iglesia, A. Marcos Delgado, C. Merino Acevedo, S. Reguero Celada, M. Rodríguez Bul, L. Vilorio-Marqués (Biomedicine Institute (IBIOMED); University of León, and Primary Health Care Management of León (Sacyl), León, Spain); L. Miró-Moriano, C. Domínguez-Espinaco, S. Vaquero-Díaz, F.J. García-Corte, A. Santos-Calonge, C. Toro-Cortés, N. Pelegrina-López, V. Urbano-Fernández, M. Ortega-Calvo, J. Lozano-Rodríguez, I. Rivera-Benítez, M. Caballero-Valderrama, P. Iglesias-Bonilla, P. Román-Torres, Y. Corchado-Albalat, L. Mellado-Martín (Department of Family Medicine, Primary Care District of Sevilla, Sevilla, Spain); A.I. de Cos, S. Gutierrez, S. Artola, A. Galdon, I. Gonzalo (Department of Endocrinology, Foundation Jiménez-Díaz, Madrid, Spain); A. Galera, M. Gimenez-Gracia, R. Figueras, M. Poch, R. Freixedas, F. Trias, I. Sarasa, M. Fanlo, H. Lafuente, M. Liceran, A. Rodriguez-Sanchez, C. Pallarols, J. Monedero, X. Corbella, E. Corbella (Lipids and Vascular Risk Unit, Internal Medicine, University Hospital of Bellvitge, Hospitalet de Llobregat, Barcelona, Spain); A. Altés, I. Vinagre, C. Mestre, J. Viaplana, M. Serra, J. Vera, T. Freitas, E. Ortega, I. Pla (Department of Endocrinology, IDIBAPS, Hospital Clinic, University of Barcelona, Barcelona, Spain); J.M. Ordovás, V. Micó, L. Berninches, M.J. Concejo, J. Muñoz, M. Adrián, Y. de la Fuente, C. Albertos, E. Villahoz, M.L. Cornejo, C. Cuesta. Montero A., Valdés, MC (Nutritional Genomics and Epigenomics Group, Institute IMDEA-Food, CEI UAM+CSIC, Madrid, Spain); J.J. Gaforio, S. Moraleda, N. Liétor, J.I. Peis, T. Ureña, M. Rueda, M.I. Ballesta (Division of Preventive Medicine, University of Jaén, Jaén, Spain); C. Moreno Lopera, C. Aragoneses Isabel, M.A. Sirur Flores, M. Ceballos de Diego, T. Bescos Cáceres, Y. Peña Cereceda, M. Martínez Abad, R. Cabrera Vélez, M. González Cerrajero, M.A. Rubio Herrera, M. Torrego Ellacuría, A. Barabash Bustelo, M. Ortiz Ramos, A. Larrad Sainz (Department of Endocrinology and Nutrition, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain); J. Fernández-Crehuet Navajas, M. Gutiérrez Bedmar, A. García Rodriguez, A. Mariscal Larrubia, M. Carnero Varo, C. Muñoz Bravo (Department of Preventive Medicine, University of Malaga, Malaga, Spain). Additional support groups: C. Botella, F. Fernandez-Aranda, R. Lamuela, A. Marcos, M. del Puy Portillo, G. Sáez.

Data Sharing Statement: See Supplement 4.

Additional Contributions: We thank all the volunteers for their participation and personnel for the contribution in the PREDIMED-Plus trial. We also thank all the investigators of the PREDIMED-Plus study. The support provided by Dr Borge Nordestgaard, MD (Department of Clinical Medicine, ‎Copenhagen University, Denmark), who did not receive compensation, to help us set minimal important differences in lipid levels is acknowledged.

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