CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (the CORDIOPREV study): Rationale, methods, and baseline characteristics

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 1002 coronary patients from Spain. Baseline assessment (2009–12) 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 BMI (37.2% overweight and 56.3% obesity), with a median of LDL-cholesterol of 88.5 mg/dL (70.6% of the patients having <100 mg/dL, and 20.3% patients < 70 mg/dL). 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.

Consumption of Two Healthy Dietary Patterns Restored Microbiota Dysbiosis in Obese Patients with Metabolic Dysfunction

“…The current work was conducted in a subgroup of 106 male patients within the CORDIOPREV study (Clinical Trials.gov.Identifier: NCT00924937), an ongoing prospective, randomized, opened, controlled trial in patients with coronary heart disease (CHD), who had their last coronary event over six months before enrolling in two different dietary models (Mediterranean and low‐fat) over a period of 5 years, in addition to conventional treatment for CHD . CORDIOPREV inclusion and exclusion criteria are summarized as follows: patients were eligible if they were over 20 years old, but under 75, had established CHD without clinical events in the last 6 months, were thought to follow a long‐term dietary intervention and did not have severe diseases or an estimated life expectancy of less than 7 years . Usage of antibiotics was included as an exclusion criteria for the current study, in addition to the general exclusion criteria defined in the CORDIOPREV study.…”

Apolipoprotein E genetic variants interact with Mediterranean diet to modulate postprandial hypertriglyceridemia in coronary heart disease patients: CORDIOPREV study

“…14 The trial was designed and conducted by the authors, and the protocol and all amendments were approved by the local ethics committees, all of which follow the Helsinki Declaration and good clinical practices. 14 The trial was designed and conducted by the authors, and the protocol and all amendments were approved by the local ethics committees, all of which follow the Helsinki Declaration and good clinical practices.…”

“…Details of the CORDIOPREV study have been provided in Clinicaltrials.gov (NCT00924937) and in a recent publication. 14 The trial was designed and conducted by the authors, and the protocol and all amendments were approved by the local ethics committees, all of which follow the Helsinki Declaration and good clinical practices.…”

Mediterranean Diet, Glucose Homeostasis, and Inflammasome Genetic Variants: The CORDIOPREV Study

“…The study design has been previously described . Briefly, participants were randomized to receive two diets: a Med diet or a low‐fat diet.…”