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Mediterranean Versus Vegetarian Diet for Cardiovascular Disease Prevention

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Mediterranean Versus Vegetarian Diet for Cardiovascular Disease Prevention Sofi et al. Trials (2016) 17:233 DOI 10.1186/s13063-016-1353-x STUDY PROTOCOL Open Access Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial Francesco Sofi1,2,3*, Monica Dinu1, Giuditta Pagliai1, Francesca Cesari1,4, Rossella Marcucci1,4 and Alessandro Casini1,2 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/design: 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. Discussion: 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. Trial registration: ClinicalTrials.gov NCT02641834 Keywords: Diet, Prevention, Cardiovascular disease, Mediterranean, Vegetarian * Correspondence: [email protected] 1Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134 Florence, Italy 2Unit of Clinical Nutrition, Careggi University Hospital, Florence, Italy Full list of author information is available at the end of the article © 2016 Sofi et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Sofi et al. Trials (2016) 17:233 Page 2 of 8 Background systematic review with a meta-analysis on more than Nutrition is able to substantially alter the health status 120,000 vegetarians, showing that adherence to a vege- of the general population [1]. In industrialized countries tarian dietary pattern helps to determine, among case- the most important association between diet and health control studies, lower levels of the most important risk is the relationship with cardiovascular disease, the lead- factor for chronic disease, along with a reduced risk of ing cause of death and disability worldwide. Therefore, occurrence for ischemic heart disease (–25 %) when co- the ability to identify with certainty the relationship be- hort prospective studies were taken into account [10]. tween diet and cardiovascular disease appears to be a Despite all these findings, however, to the best of our key element in the implementation of specific primary knowledge, no randomized controlled trial that com- prevention strategies [2]. Recent studies have focussed pares, in the same group of patients, the efficacy of nu- their interest on the impact of a whole dietary approach tritional interventions based on Mediterranean and rather than on isolating single nutrients on the occur- vegetarian dietary patterns is available in the literature. rence of cardiovascular disease; it is recognized that ana- To date, it is unclear whether the supposed health bene- lyses of single nutrients ignore the important and fits for vegetarians can be attributed to the absence of complex interactions between components of a diet and, meat in the diet, to the increased consumption of par- more importantly, ignore the fact that people do not eat ticular food component(s), to the pattern of foods eaten isolated nutrients [3, 4]. However, an optimal dietary within the vegetarian diet or to other healthy lifestyle strategy for the prevention of cardiovascular disease has components often associated with vegetarianism. not been found [5]. Hence, we aimed to design this randomized, open, Several models of diet have been imposed on public crossover clinical trial that will test whether there is a attention, but those that have received the most interest difference between a vegetarian calorie-restricted diet are the Mediterranean and vegetarian diets [6, 7]. These and a Mediterranean calorie-restricted diet in reducing dietary patterns seem to exert protective effects on blood total weight and ameliorating the cardiovascular risk pressure, lipid profiles, cardiovascular diseases and meta- profile of a clinically healthy group of subjects. bolic parameters. The term Mediterranean diet has been widely used to Methods/design describe the traditional dietary habits of people in Crete, Study design and setting South Italy and other Mediterranean countries during The randomized, open, crossover clinical trial will be the decade of the 1960s. This dietary pattern is charac- conducted at the Unit of Clinical Nutrition of the terized by plentiful plant-derived foods (fruits, vegeta- Careggi University Hospital, Florence, Italy. A crossover bles, breads, other forms of cereals, beans, nuts and design will be implemented to allow comparison of the seeds), olive oil as the principal source of fat, moderate vegetarian and Mediterranean diets within the same in- amounts of dairy products (mainly cheese and yogurt), dividual. Participants will act as their own controls in low-to-moderate amounts of fish and meat and a moder- crossover studies, so individual differences will be con- ate consumption, usually with meals. Since the results of trolled for, making the error variance smaller and subse- the first data from the Seven Countries Study, several quently reducing the sample size required to find a studies in different populations have established a bene- significant effect due to increased statistical power. This ficial role for the main components of the Mediterra- design will also be adopted in an effort to minimize at- nean diet on the occurrence of cardiovascular and trition and to maximize participant interest and compli- chronic degenerative diseases [8]. Recently, a meta- ance by enabling each participant to experience both analysis conducted by our group has revealed, in a popu- diet conditions. The study design follows the SPIRIT lation of more than 2 million people, that a strict adher- guidelines (see Additional files 1 and 2). ence to a Mediterranean dietary pattern is associated with a significant improvement in health status, as seen Eligibility criteria by a significant reduction in overall mortality (10 %) and Eligible participants will be clinically healthy subjects incidence of and/or mortality from cardiovascular dis- (aged 18–75 years) with a low-to-medium cardiovascular eases (9 %) [9]. risk profile (1–5 % according to the guidelines of the A vegetarian diet is a dietary profile characterized by European Society of Cardiology) [11], determined by be- abstention from consuming meat and meat products, ing overweight (body mass index >25.1 kg/m2) and by poultry, seafood and flesh from any other animal. In the the concomitant presence of at least one of the following past few decades, some case-control and cohort pro- criteria: spective studies reported beneficial effects of this dietary profile on the occurrence of cardiovascular and neoplas- Waist circumference >88 cm (women) or >102 cm tic disease. Very recently, our group conducted a (men) Sofi et al. Trials (2016) 17:233 Page 3 of 8 Circulating levels of total cholesterol >190 mg/dL, per day for men. Participants will be asked not to alter not on drug treatment (measured no more than their exercise habits during the study. 3 months prior to the start of the study) Standardized baseline assessment for both groups will Circulating levels of LDL cholesterol >115 mg/dL, include a questionnaire regarding demographic informa- not on drug treatment (measured no more than tion, risk factors and co-morbidities. Moreover, at the
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