Coronary diet intervention with olive oil and cardiovascular prevention study (the CORDIOPREV study); rationale, methods, and baseline characteristics: a clinical trial comparing the efficacy of a Mediterranean diet rich...

Authors: DELGADO-LISTA, JAVIER - Universidad De Cordoba; PEREZ-MARTINEZ, PABLO - Universidad De Cordoba; GARCIA-RIOS, ANTONIO - Universidad De Cordoba; ALCALA-DIAZ, JUAN - Universidad De Cordoba; PEREZ-CABALLERO, ANA - Universidad De Cordoba; GOMEZ-DELGADO, FRANCISCO - Universidad De Cordoba; FUENTES, FRANCISCO - Universidad De Cordoba; QUINTANA-NAVARRO, GRACIA - Universidad De Cordoba; LOPEZ-SEGURA, FERNANDO - Universidad De Cordoba; ORTIZ-MORALES, ANA - Universidad De Cordoba; DELGADO-CASADO, NIEVES - Universidad De Cordoba; YUBERO-SERRANO, ELENA - Universidad De Cordoba; CAMARGO, ANTONIO - Universidad De Cordoba; MARIN, CARMEN - Universidad De Cordoba; RODRIGUEZ-CANTALEJO, FERNANDO - University Hospital Reina Sofia; GOMEZ-LUNA, PURIFICACION - Universidad De Cordoba; ORDOVAS, JOSE - Jean Mayer Human Nutrition Research Center On Aging At Tufts University; LOPEZ-MIRANDA, JOSE - Universidad De Cordoba; PEREZ-JIMENEZ, FRANCISCO - Universidad De Cordoba

Submitted to: American Heart Journal
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 4/22/2016
Publication Date: 7/1/2016
Citation: Delgado-Lista, J., Perez-Martinez, P., Garcia-Rios, A., Alcala-Diaz, J.F., Perez-Caballero, A.I., Gomez-Delgado, F., Fuentes, F., Quintana-Navarro, G., Lopez-Segura, F., Ortiz-Morales, A.M., Delgado-Casado, N., Yubero-Serrano, E.M., Camargo, A., Marin, C., Rodriguez-Cantalejo, F., Gomez-Luna, P., Ordovas, J.M., Lopez-Miranda, J., Perez-Jimenez, F. 2016. Coronary diet intervention with olive oil and cardiovascular prevention study (the CORDIOPREV study); rationale, methods, and baseline characteristics: a clinical trial comparing the efficacy of a Mediterranean diet rich in olive oil versus a low-fat diet on cardiovascular disease in coronary patients. American Heart Journal. doi: 10.1016/j.ahj.2016.04.011.

Interpretive Summary: Coronary heart disease (CHD) represents a major global health burden worldwide. The Mediterranean Diet has been largely associated with lowering CHD rates and has been proven to influence some of the CHD risk factors. However, the current evidence for the effects of the Mediterranean Diet on the progression of CHD is sometimes based on observational studies, which do not have the high level of scientific evidence contributed by randomized dietary intervention studies. Therefore, the objective of the CORonary Diet Intervention with olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the efficacy of the Mediterranean Diet versus a low-fat diet to influence the progression of the disease (the incidence of cardiovascular events) after 7 years in subjects with documented CHD at baseline. 1,002 coronary patients have been included in this study, and we are currently following up with them. This paper provides the rationale of the CORDIOPREV study and shows the baseline characteristics of the population. In summary, the CORDIOPREV study will test for the first time the efficacy of a Mediterranean diet rich in extra virgin olive oil compared to a low-fat diet on the incidence of CHD recurrence in a long-term dietary intervention study and will contribute to shaping future guidelines.

Technical Abstract: Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the Coronary Diet Intervention with Olive oil and cardiovascular Prevention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years in subjects with documented CHD at baseline. For this purpose, we enrolled 1,002 coronary patients from Spain. Baseline assessment (2009-2012) included detailed interviews and measurements to assess dietary, social, and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high body mass index (37.2% overweight and 56.3% obesity) and with a median of low-density lipoprotein cholesterol of 88.5 mg/dL (70.6% of the patients having <100 mg/dL and 20.3% patients <70 mg/dL). A total of 9.6% of the participants were active smokers, and 64.4% were former smokers. Metabolic syndrome was present in 58% of this population. To sum up, we describe here the rationale, methods, and baseline characteristics of the CORDIOPREV study, which will test for the first time the efficacy of a Mediterranean diet rich in extra virgin olive oil as compared with a low-fat diet on the incidence of CHD recurrence in a long-term follow-up study.