ORIGINAL ARTICLE Safety and efficacy of a multiphase dietetic protocol with meal replacements including a step with very low calorie diet Sabrina Basciani • Daniela Costantini • Savina Contini • Agnese Persichetti • Mikiko Watanabe • Stefania Mariani • Carla Lubrano • Giovanni Spera • Andrea Lenzi • Lucio Gnessi Received: 6 May 2014 / Accepted: 29 June 2014 Ó Springer Science+Business Media New York 2014 Abstract To investigate safety, compliance, and efficacy, on weight loss and cardiovascular risk factors of a multi- phasic dietary intervention based on meal replacements, including a period of very low calorie diet (VLCD) in a population of obese patients. Anthropometric parameters, blood tests (including insulin), dual-energy-X-ray absorp- tiometry (DXA), and questionnaires for the assessment of safety and compliance before and after (phase I) a 30-day VLCD, 700 kcal/day, normoproteic, 50 g/day carbohy- drate, four meal replacements; (phase II) a 30-day low calorie diet (LCD), 820 kcal/day, three meal replacements plus a protein plate; (phase III) 60-day LCD, 1,100 kcal/ day, two meal replacements plus two protein plates and reintroduction of small amounts of carbohydrates; (phase IV) 60-day hypocaloric balanced diet (HBD), 1,200 kcal/ day, one meal replacement, two protein plates and the reintroduction of carbohydrates. 24 patients (17 females, 7 males, mean BMI 33.8 ± 3.2 kg/m 2 , mean age 35.1 ± 10.2 years) completed the study. The average weight loss was 15.4 ± 6.7 %, with a significant reduction of fat mass (from 32.8 ± 4.7 to 26.1 ± 6.3 % p \ 0.05) and a relative increase of lean mass (from 61.9 ± 4.8 to 67.1 ± 5.9 % p \ 0.05). An improvement of metabolic parameters and no variations of the liver and kidney functions were found. A high safety profile and an excel- lent dietary compliance were seen. The VLCD dietary program and the replacement dietary system described here is an effective, safe, and well-tolerated treatment for weight control. Keywords Safety Á Efficacy Á Diet Á Very low calorie Introduction Obesity is a chronic disease. Treatment of obesity includes hypocaloric diet, exercise, lifestyle modifications, use of endoscopic device (e.g., intragastric balloon), drugs, and bariatric surgery [1–3]. The therapeutic benefit of all cur- rently available anti-obesity interventions is often limited by their subjective efficacy, variable tolerability, safety profiles, and poor compliance, the latter being a hard lim- iting variable, especially when long-term treatments are needed. In addition to obesity, diets play a pivotal role in the clinical treatment of a bunch of health conditions, such as dyslipidemia, diabetes, cardiovascular diseases, hyper- tension, and many others [4]. Often, the poor efficacy in terms of adequate and pro- longed weight loss is ascribable to difficulties in the adherence to the diets. Furthermore, most patients expect fast weight reduction with the least possible effort. Therefore, they often follow unsafe, although popular dieting programs, which may be also dangerous for their health [5]. A series of programs have been studied to guide the overweight-obese patients throughout a reduction of body weight and a long lasting maintenance of such reduction. Unfortunately, clinical experience and scientific data suggest that this target is difficult to achieve in a high percentage of cases [5, 6]. Furthermore, an effective pro- gram for weight reduction should be followed for long time [7]. Emerging evidences suggest that rapid initial weight loss results in better long-term weight loss maintenance [8]. S. Basciani Á D. Costantini Á S. Contini Á A. Persichetti Á M. Watanabe Á S. Mariani Á C. Lubrano Á G. Spera Á A. Lenzi Á L. Gnessi (&) Department of Experimental Medicine, Section of Medical Pathophysiology Food Science and Endocrinology, Sapienza University of Rome La Sapienza, Policlinico Umberto I, 00161 Rome, Italy e-mail: lucio.gnessi@uniroma1.it 123 Endocrine DOI 10.1007/s12020-014-0355-2