title: Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Nutrition is able to alter the cardiovascular health of the general population. However, the optimal dietary strategy for cardiovascular disease prevention is still far from being defined. Mediterranean and vegetarian diets are those reporting the greatest grade of evidence in the literature, but no experimental studies comparing these two dietary patterns are available.
  
  
  METHODS
  This is an open randomized crossover clinical trial including healthy subjects with a low-to-medium cardiovascular risk profile, characterized by being overweight and by the presence of at least an additional metabolic risk factor (abdominal obesity, high total cholesterol, high LDL cholesterol, high triglycerides, impaired glucose fasting levels) but free from medications. A total of 100 subjects will be included and randomly assigned to two groups: Mediterranean calorie-restricted diet (n = 50) and vegetarian calorie-restricted diet (n = 50). The intervention phases will last 3 months each, and at the end of intervention phase I the groups will be crossed over. The two diets will be isocaloric and of three different sizes (1400 - 1600 - 1800 kcal/day), according to specific energy requirements. Adherence to the dietary intervention will be established through questionnaires and 24-h dietary recall. Anthropometric measurements, body composition, blood samples and stool samples will be obtained from each participant at the beginning and at the end of each intervention phase. The primary outcome measure will be change in weight from baseline. The secondary outcome measures will be variations of anthropometric and bioelectrical impedance variables as well as traditional and innovative cardiovascular biomarkers.
  
  
  CONCLUSIONS
  Despite all the data supporting the efficacy of Mediterranean and vegetarian diets on the prevention of cardiovascular diseases, no studies have directly compared these two dietary profiles. The trial will test whether there are statistically significant differences between these dietary profiles in reducing the cardiovascular risk burden for the general population.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02641834.
authors.affiliation: Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy. francesco.sofi@unifi.it.|Unit of Clinical Nutrition, Careggi University Hospital, Florence, Italy. francesco.sofi@unifi.it.|Don Carlo Gnocchi Foundation Italy, Onlus IRCCS, Florence, Italy. francesco.sofi@unifi.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Sofi
authors.affiliation: Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Dinu
authors.affiliation: Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.
authors.forename: Giuditta
authors.initials: G
authors.lastname: Pagliai
authors.affiliation: Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.|Unit of Atherothrombotic Diseases, Careggi University Hospital, Florence, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Cesari
authors.affiliation: Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.|Unit of Atherothrombotic Diseases, Careggi University Hospital, Florence, Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Marcucci
authors.affiliation: Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.|Unit of Clinical Nutrition, Careggi University Hospital, Florence, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Casini
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D031204:Caloric Restriction; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D002985:Clinical Protocols; D018592:Cross-Over Studies; D000072001:Diet, Healthy; D038441:Diet, Mediterranean; D014676:Diet, Vegetarian; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications / Q000175:diagnosis / Q000178:diet therapy*; D008875:Middle Aged; D009752:Nutritional Status; D009753:Nutritive Value; D050177:Overweight / Q000150:complications / Q000175:diagnosis / Q000178:diet therapy*; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Cardiovascular disease; Diet; Mediterranean; Prevention; Vegetarian