Efficacy and safety of very-low-calorie diet in Taiwanese: A multicenter randomized, controlled trial

Objective: Very-low-calorie diets (VLCDs) are an effective method for weight reduction in Caucasians. This study investigated the efficacy and safety of two different VLCDs (450 or 800 kcal/d) in obese Taiwanese. Methods: 132 participants with BMI >= 30 kg/m(2) were randomized to two VLCD groups for body weight reduction for 12 weeks. Each group had 66 participants. Anthropometric and metabolic parameters were measured. Results: The intention-to-treat analysis revealed that the percentage change in body weight over the 12-week treatment period was -9.14% in the VLCD-450 group and -8.98% in the VLCD-800 group. A total of 27 (40.9%) participants in the VLCD-450 group and 29 (43.9%) participants in the VLCD-800 group achieved 10% or more weight loss at the end of treatment. The body weight, waist circumference, hip circumference, fat mass, blood pressure, triglycerides, and blood glucose were statistically improved from baseline but not between the two groups. The improvement rate of nonalcoholic fatty liver disease (NAFLD) was 41.5% in the VLCD-450 group and 50.0% in the VLCD-800 group. The incidence of adverse events did not differ significantly between the groups and no serious adverse events were reported in either group. Conclusion: Both the VLCD-450 and 800 kcal/d can effectively and safely reduce body weight and improve NAFLD in 12 weeks in obese Taiwanese participants. However, there is no additional benefit in prescribing the more restrictive diet intervention in Taiwanese. (C) 2009 Elsevier Inc. All rights reserved.