Trial DesignCORonary 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
Section snippets
Objectives
The primary outcome of the CORDIOPREV study is to compare the appearance of a composite of cardiovascular events after an average follow-up of 7 years in secondary prevention with 2 dietary models: a Mediterranean diet (rich in olive oil) and a low-fat diet. The composite outcome includes the following cardiovascular events: myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease, and cardiovascular death.
Prespecified secondary outcomes include clinical,
Overall design
The CORDIOPREV study (Clinicaltrials.gov number NCT00924937) is a randomized, single-blind, controlled dietary intervention trial in CHD patients with high cardiovascular risk, with an intention-to-treat analysis basis.
The study is being conducted at the Instituto Maimonides de Investigacion Biomedica de Cordoba, a scientific institute which carries out research into biomedical areas for the Reina Sofia University Hospital, and the University of Cordoba, Spain. The lipids and atherosclerosis
Results of baseline measurements
Up to February 2012, a total of 1,002 participants were included in the CORDIOPREV study. Table IV shows baseline characteristics. The mean age was 59.5 years. The subjects were predominantly male (83.5%), former smokers (64.6%), and consumers of alcohol (82.6%), mostly in moderation (<14 g/d, mainly red wine). Adherence rates to the Mediterranean diet and the low-fat scores were 8.78 and 3.81 for the whole sample (regardless of the randomization group to which they were assigned), on scores
Discussion and conclusions
The evidence for the influence of the Mediterranean diet on the clinical course of CHD is sparse. Despite the well-established healthy effects of this dietary pattern on multiple cardiovascular risk factors, either traditional ones such as lipids or hypertension, or new emerging ones (endothelial function, oxidative stress, inflammation, obesity, metabolic syndrome, or type 2 diabetes mellitus),14, 15, 24, 42, 43, 44 there is a paucity of studies evaluating its effectiveness in reducing the
Funding and Acknowledgements
We would like to thank the Escuela Andaluza de Salud Pública and especially Dr Antonio Daponte for performing the randomization process. We also want to thank Dr Miguel Angel Martinez González for his valuable help in the statistical approach. The CORDIOPREV study is supported by the Fundacion Patrimonio Comunal Olivarero. The main sponsor agreed to participate in the study because, when it started, there were no full-length studies evaluating the effect of an olive oil–based Mediterranean diet
References (44)
- et al.
European guidelines on cardiovascular disease prevention in clinical practice (version 2012): the Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts)
Atherosclerosis
(2012) - et al.
Effects of changes in fat, fish, and fibre intakes on death and myocardial reinfarction: Diet and Reinfarction Trial (DART)
Lancet
(1989) - et al.
Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease
Lancet
(1994) - et al.
Effect of diet and smoking intervention on the incidence of coronary heart disease. Report from the Oslo Study Group of a randomised trial in healthy men
Lancet
(1981) - et al.
Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial
Lancet
(1990) - et al.
Nutrient intake and progression of coronary artery disease
Am J Cardiol
(1994) - et al.
Effects on coronary artery disease of lipid-lowering diet, or diet plus cholestyramine, in the St Thomas' Atherosclerosis Regression Study (STARS)
Lancet
(1992) - et al.
Adherence to the Mediterranean diet and risk of metabolic syndrome and its components
Nutr Metab Cardiovasc Dis
(2009) - et al.
Olive oil and health: summary of the II international conference on olive oil and health consensus report, Jaen and Cordoba (Spain) 2008
Nutr Metab Cardiovasc Dis
(2010) - et al.
Adherence to a Mediterranean-type dietary pattern and cognitive decline in a community population
Am J Clin Nutr
(2011)
A questionnaire for the assessment of leisure time physical activities
J Chronic Dis
The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments
Gac Sanit
Prevalence and profile of metabolic syndrome in patients following acute coronary events and effects of therapeutic lifestyle change with cardiac rehabilitation
Am J Cardiol
Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies
Lancet
The Oslo diet-heart study. Eleven-year report
Circulation
Dietary prevention of coronary heart disease: the Finnish Mental Hospital Study
Int J Epidemiol
2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
Circulation
Adherence to the Mediterranean diet in patients with type 2 diabetes mellitus and HbA1c level
Ann Nutr Metab
Anti-inflammatory effects of the Mediterranean diet: the experience of the PREDIMED study
Proc Nutr Soc
Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial
Ann Intern Med
Cohort profile: design and methods of the PREDIMED study
Int J Epidemiol
Reduction in the incidence of type 2 diabetes with the Mediterranean diet: results of the PREDIMED-Reus nutrition intervention randomized trial
Diabetes Care
Cited by (0)
RCT# NCT0092493741
The CORDIOPREV study is supported by the Fundacion Patrimonio Comunal Olivarero. Also received additional funding from CITOLIVA, CEAS, Junta de Andalucia (Consejeria de Salud, Consejeria de Agricultura y Pesca, Consejeria de Innovacion, Ciencia y Empresa), Diputaciones de Jaen y Cordoba, Centro de Excelencia en Investigacion sobre Aceite de Oliva y Salud and Ministerio de Medio Ambiente, Medio Rural y Marino, and the Spanish Government. The study was also cofinanced by the Fondo Europeo de Desarrollo Regional. Also partly supported by research grants from the Ministerio de Ciencia e Innovacion (AGL2009-122270 to J. L.-M., FIS PI10/01041 to P. P.-M., FIS PI13/00023 to J. D.-L.); Ministerio de Economia y Competitividad (AGL2012/39615 to J. L.-M.); Consejeria de Salud, Junta de Andalucia (PI0193/09 to J. L.-M., PI-0252/09 to J. D.-L., PI-0058/10 to P. P.-M., PI-0206-2013 to A. G.-R.); and Proyecto de Excelencia, Consejería de Economía, Innovación, Ciencia y Empleo (CVI-7450 to J. L.-M.).
- g
These 2 authors contributed equally to this article as first authors.
- h
These two authors contributed equally as corresponding authors and main researchers of this article.