Understanding the mediterranean diet
Abstract Background Trials comparing the effectiveness and safety of weight-loss diets are frequently limited by short follow-up times and high dropout rates. Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. Methods Eligibility and Study Design We conducted the trial between July 2005 and June 2007 in Dimona, Israel, in a workplace at a research center with an on-site medical clinic. All participants provided written informed consent. Conclusions Mediterranean and low-carbohydrate diets may be effective alternatives to low-fat diets. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events. org. Beginning on October 1, 2003, participants were randomly assigned, in a 1:1:1 ratio, to one of three dietary intervention groups: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with nuts, or a control diet. A primary end-point event occurred in 288 participants. Methods In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: 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). The criteria for eligibility were an age of 40 to 65 years and a body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) of at least 27, or the presence of type 2 diabetes (according to the American Diabetes Association criteria 18 ) or coronary heart disease, regardless of age and BMI. ) Full Text of Discussion. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). 6% at 2 years. Abstract Background Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. The more favorable effects on lipids (with the low-carbohydrate diet) and on glycemic control (with the Mediterranean diet) suggest that personal preferences and metabolic considerations might inform individualized tailoring of dietary interventions.
Detailed enrollment criteria are provided in the Supplementary Appendix, available at NEJM. None of the sponsors had any role in the trial design, data analysis, or reporting of the results. (ClinicalTrials. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. gov number, NCT00160108. 4% at 1 year and 84. Results The rate of adherence to a study diet was 95. 8 years. The Mediterranean-diet group consumed the largest amounts of dietary fiber and had the highest ratio of monounsaturated to saturated fat (P Full Text of Results. Full Text of Methods. Figure 2 Weight Changes during 2 Years According to Diet Group. Details of the trial design are provided elsewhere. 10-12 The trial was designed and conducted by the authors, and the protocol was approved by the institutional review boards at all study locations. On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4. Media in This Article Figure 1 Enrollment of the Participants and Completion of the Study. The participants were randomly assigned within strata of sex, age (below or above the median), BMI (below or above the median), history of coronary heart disease (yes or no), history of type 2 diabetes (yes or no), and current use of statins (none, The members of each of the three diet groups were assigned to subgroups of 17 to 19 participants, with six subgroups for each group.
