Nutrition professor appointed to oversight of PREDIMED study
The members of the monitoring committee are (from left) Joan Sabaté, MD, DrPH; Frank Hu, MD, PhD, MPH; Xavier Pi-Sunyer, MD, MPH; and Carlos Gonzelez, MD.
The School of Public Health at Loma Linda University is once again making strides in international nutrition and public health. Joan Sabaté, MD, DrPH, chair of the department of nutrition at the School, has been appointed to the Data Safety and Monitoring Board (DSMB) committee to provide oversight to the PREDIMED Study (Prevención con Dieta Mediterránea Study), a clinical trial currently being conducted in Spain.
The other three members of this committee are Frank Hu, MD, PhD, MPH, from Harvard University; Xavier Pi-Sunyer, MD, MPH, from Columbia University; and Carlos Gonzalez, MD, from the Catalan Institute of Cardiology. The committee’s first meeting was held in April in Barcelona, Spain.
The PREDIMED Study is a large, multi-center, randomized controlled, five-year clinical trial that aims to assess the effects of the Mediterranean diet on the primary prevention of cardiovascular disease. See <www.predimed.org>.
An estimated 6,000 high-risk participants have been recruited and assigned to three interventions: Mediterranean diet with virgin olive oil, Mediterranean diet with mixed tree nuts, or a low-fat diet. Although having the same general food pattern, the two treatment arms of the study differ in the intake of two foods (extra virgin olive oil and nuts) and two nutrients (phenolics and omega-3 fats respectively) that are felt to be important in cardiovascular prevention and may have differential beneficial effects.
Cardiovascular disease is the main cause of death in industrialized countries, but incidence rates have marked geographic differences. The low incidence of coronary heart disease (CHD) in Mediterranean countries has been partly ascribed to dietary habits. The main purpose of the PREDIMED study is to measure the number of cardiovascular disease events (nonfatal myocardial infarction, nonfatal stroke and cardiovascular disease death).
The trial has been registered in Current Controlled Trials (London). The study is funded by the Spanish Ministry of Health-Instituo de Salud Carlos III (ISCIII), Spain’s equivalent to the National Institutes of Health in the United States.
The DSMB of a clinical trial provides oversight by reviewing participant adherence, quality control, and clinical outcome data from each of the centers. The board members offer guidance for refining the purpose of the study and recommending adjustments to the protocol.