Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial

IMPORTANCE: Breast cancer is the leading cause of female cancer burden, and its incidence has increased by more than 20% worldwide since 2008. Some observational studies have suggested that the Mediterranean diet may reduce the risk of breast cancer. OBJECTIVE: To evaluate the effect of 2 interventi...

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Autores: Toledo Atucha, Estefanía, Salas Salvadó, Jordi, Donat Vargas, Carolina, Buil Cosiales, Pilar, Estruch Riba, Ramon, Ros Rahola, Emilio, Corella Piquer, Dolores, Fitó Colomer, Montserrat, Hu, Frank B., Arós, Fernando, Gómez Gracia, Enrique, Romaguera, Dora, Ortega Calvo, Manuel, Serra Majem, Lluís, Pintó Sala, Xavier, Schröder, Helmut, 1958-, Basora, Josep, Sorlí, José V., Bulló, Mònica, Serra-Mir, Mercè, Martínez-González, Miguel Ángel, 1957-
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2015
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/118863
Acceso en línea:https://hdl.handle.net/2445/118863
Access Level:acceso abierto
Palabra clave:Assaigs clínics
Cuina mediterrània
Medicina preventiva
Càncer de mama
Dones
Clinical trials
Mediterranean cooking
Preventive medicine
Breast cancer
Women
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spelling Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trialToledo Atucha, EstefaníaSalas Salvadó, JordiDonat Vargas, CarolinaBuil Cosiales, PilarEstruch Riba, RamonRos Rahola, EmilioCorella Piquer, DoloresFitó Colomer, MontserratHu, Frank B.Arós, FernandoGómez Gracia, EnriqueRomaguera, DoraOrtega Calvo, ManuelSerra Majem, LluísPintó Sala, XavierSchröder, Helmut, 1958-Basora, JosepSorlí, José V.Bulló, MònicaSerra-Mir, MercèMartínez-González, Miguel Ángel, 1957-Assaigs clínicsCuina mediterràniaMedicina preventivaCàncer de mamaDonesClinical trialsMediterranean cookingPreventive medicineBreast cancerWomenIMPORTANCE: Breast cancer is the leading cause of female cancer burden, and its incidence has increased by more than 20% worldwide since 2008. Some observational studies have suggested that the Mediterranean diet may reduce the risk of breast cancer. OBJECTIVE: To evaluate the effect of 2 interventions with Mediterranean diet vs the advice to follow a low-fat diet (control) on breast cancer incidence. DESIGN, SETTING, AND PARTICIPANTS: The PREDIMED study is a 1:1:1 randomized, single-blind, controlled field trial conducted at primary health care centers in Spain. From 2003 to 2009, 4282 women aged 60 to 80 years and at high cardiovascular disease risk were recruited after invitation by their primary care physicians. INTERVENTIONS: Participants were randomly allocated to 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). MAIN OUTCOMES AND MEASURES: Breast cancer incidence was a prespecified secondary outcome of the trial for women without a prior history of breast cancer (n = 4152). RESULTS: After a median follow-up of 4.8 years, we identified 35 confirmed incident cases of breast cancer. Observed rates (per 1000 person-years) were 1.1 for the Mediterranean diet with extra-virgin olive oil group, 1.8 for the Mediterranean diet with nuts group, and 2.9 for the control group. The multivariable-adjusted hazard ratios vs the control group were 0.32 (95% CI, 0.13-0.79) for the Mediterranean diet with extra-virgin olive oil group and 0.59 (95% CI, 0.26-1.35) for the Mediterranean diet with nuts group. In analyses with yearly cumulative updated dietary exposures, the hazard ratio for each additional 5% of calories from extra-virgin olive oil was 0.72 (95% CI, 0.57-0.90). CONCLUSIONS AND RELEVANCE: This is the first randomized trial finding an effect of a long-term dietary intervention on breast cancer incidence. Our results suggest a beneficial effect of a Mediterranean diet supplemented with extra-virgin olive oil in the primary prevention of breast cancer. These results come from a secondary analysis of a previous trial and are based on few incident cases and, therefore, need to be confirmed in longer-term and larger studies.American Medical Association2015info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/118863Articles publicats en revistes (Medicina)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1001/jamainternmed.2015.4838JAMA Internal Medicine, 2015, vol. 175, num. 11, p. 1752-1760https://doi.org/10.1001/jamainternmed.2015.4838(c) American Medical Association, 2015info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1188632026-05-27T06:46:51Z
dc.title.none.fl_str_mv Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial
title Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial
spellingShingle Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial
Toledo Atucha, Estefanía
Assaigs clínics
Cuina mediterrània
Medicina preventiva
Càncer de mama
Dones
Clinical trials
Mediterranean cooking
Preventive medicine
Breast cancer
Women
title_short Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial
title_full Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial
title_fullStr Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial
title_full_unstemmed Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial
title_sort Mediterranean diet and invasive breast cancer risk among women at high cardiovascular risk in the PREDIMED Trial: A randomized clinical trial
dc.creator.none.fl_str_mv Toledo Atucha, Estefanía
Salas Salvadó, Jordi
Donat Vargas, Carolina
Buil Cosiales, Pilar
Estruch Riba, Ramon
Ros Rahola, Emilio
Corella Piquer, Dolores
Fitó Colomer, Montserrat
Hu, Frank B.
Arós, Fernando
Gómez Gracia, Enrique
Romaguera, Dora
Ortega Calvo, Manuel
Serra Majem, Lluís
Pintó Sala, Xavier
Schröder, Helmut, 1958-
Basora, Josep
Sorlí, José V.
Bulló, Mònica
Serra-Mir, Mercè
Martínez-González, Miguel Ángel, 1957-
author Toledo Atucha, Estefanía
author_facet Toledo Atucha, Estefanía
Salas Salvadó, Jordi
Donat Vargas, Carolina
Buil Cosiales, Pilar
Estruch Riba, Ramon
Ros Rahola, Emilio
Corella Piquer, Dolores
Fitó Colomer, Montserrat
Hu, Frank B.
Arós, Fernando
Gómez Gracia, Enrique
Romaguera, Dora
Ortega Calvo, Manuel
Serra Majem, Lluís
Pintó Sala, Xavier
Schröder, Helmut, 1958-
Basora, Josep
Sorlí, José V.
Bulló, Mònica
Serra-Mir, Mercè
Martínez-González, Miguel Ángel, 1957-
author_role author
author2 Salas Salvadó, Jordi
Donat Vargas, Carolina
Buil Cosiales, Pilar
Estruch Riba, Ramon
Ros Rahola, Emilio
Corella Piquer, Dolores
Fitó Colomer, Montserrat
Hu, Frank B.
Arós, Fernando
Gómez Gracia, Enrique
Romaguera, Dora
Ortega Calvo, Manuel
Serra Majem, Lluís
Pintó Sala, Xavier
Schröder, Helmut, 1958-
Basora, Josep
Sorlí, José V.
Bulló, Mònica
Serra-Mir, Mercè
Martínez-González, Miguel Ángel, 1957-
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Assaigs clínics
Cuina mediterrània
Medicina preventiva
Càncer de mama
Dones
Clinical trials
Mediterranean cooking
Preventive medicine
Breast cancer
Women
topic Assaigs clínics
Cuina mediterrània
Medicina preventiva
Càncer de mama
Dones
Clinical trials
Mediterranean cooking
Preventive medicine
Breast cancer
Women
description IMPORTANCE: Breast cancer is the leading cause of female cancer burden, and its incidence has increased by more than 20% worldwide since 2008. Some observational studies have suggested that the Mediterranean diet may reduce the risk of breast cancer. OBJECTIVE: To evaluate the effect of 2 interventions with Mediterranean diet vs the advice to follow a low-fat diet (control) on breast cancer incidence. DESIGN, SETTING, AND PARTICIPANTS: The PREDIMED study is a 1:1:1 randomized, single-blind, controlled field trial conducted at primary health care centers in Spain. From 2003 to 2009, 4282 women aged 60 to 80 years and at high cardiovascular disease risk were recruited after invitation by their primary care physicians. INTERVENTIONS: Participants were randomly allocated to 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). MAIN OUTCOMES AND MEASURES: Breast cancer incidence was a prespecified secondary outcome of the trial for women without a prior history of breast cancer (n = 4152). RESULTS: After a median follow-up of 4.8 years, we identified 35 confirmed incident cases of breast cancer. Observed rates (per 1000 person-years) were 1.1 for the Mediterranean diet with extra-virgin olive oil group, 1.8 for the Mediterranean diet with nuts group, and 2.9 for the control group. The multivariable-adjusted hazard ratios vs the control group were 0.32 (95% CI, 0.13-0.79) for the Mediterranean diet with extra-virgin olive oil group and 0.59 (95% CI, 0.26-1.35) for the Mediterranean diet with nuts group. In analyses with yearly cumulative updated dietary exposures, the hazard ratio for each additional 5% of calories from extra-virgin olive oil was 0.72 (95% CI, 0.57-0.90). CONCLUSIONS AND RELEVANCE: This is the first randomized trial finding an effect of a long-term dietary intervention on breast cancer incidence. Our results suggest a beneficial effect of a Mediterranean diet supplemented with extra-virgin olive oil in the primary prevention of breast cancer. These results come from a secondary analysis of a previous trial and are based on few incident cases and, therefore, need to be confirmed in longer-term and larger studies.
publishDate 2015
dc.date.none.fl_str_mv 2015
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/118863
url https://hdl.handle.net/2445/118863
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1001/jamainternmed.2015.4838
JAMA Internal Medicine, 2015, vol. 175, num. 11, p. 1752-1760
https://doi.org/10.1001/jamainternmed.2015.4838
dc.rights.none.fl_str_mv (c) American Medical Association, 2015
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) American Medical Association, 2015
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv American Medical Association
publisher.none.fl_str_mv American Medical Association
dc.source.none.fl_str_mv Articles publicats en revistes (Medicina)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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