Abstract
AIMS/INTRODUCTION: Using an investigational diet plan based on the Mediterranean diet and the Dietary Approaches to Stop Hypertension diet comprised of substitute ingredients that mimic the average East Asian diet, this study assessed the glycemic benefits in comparison with a food exchange system-based diet in established type 2 diabetes patients. MATERIALS AND METHODS: This was a 12-week, open-label randomized clinical trial carried out among 60 Korean adults with type 2 diabetes having a median body mass index of 23.5 kg/m(2) . Glycemic benefits in the investigational diet (group A) were compared with those obtained with a food exchange system-based diet, either in the form of ready meals provided to participants (group B) or not (group C). The primary end-point was changes in glycated hemoglobin from baseline to week 12. RESULTS: Changes in glycated hemoglobin (%) from baseline to week 12 were -0.97 ± 0.97 in group A (vs group B, P = 0.085 in the full analysis set, and P = 0.028 in the per-protocol set; vs group C, P = 0.030 in the full analysis set and P = 0.020 in the per-protocol set), -0.51 ± 0.65 in group B (vs group C, P > 0.05 in the full analysis set and the per-protocol set), and -0.36 ± 0.74 in group C. Decreases from baseline in body mass index, waist circumference and blood pressure were greater in group A than in group C. CONCLUSION: With the provision of ready meals, the glycemic benefits of the investigational diet plan were demonstrable over a self-prepared food exchange system-based diet in Korean adults with established type 2 diabetes.