ORIGINAL COMMUNICATION Long-term efficacy of soy-based meal replacements vs an individualized diet plan in obese type II DM patients: relative effects on weight loss, metabolic parameters, and C-reactive protein

Background: Achieving significant weight loss and glycemic control in diabetic patients remains a challenging task. Objective: This study compared the effects of a soy-based meal replacement (MR) plan vs an individualized diet plan (IDP; as recommended by the American Diabetes Association) on weight loss and metabolic profile. Design/Subjects: A total of 104 subjects were randomized prospectively to the two treatments for a total of 12 months. Results: In all, 77 of the 104 subjects completed the study. Percentage weight loss in MR group (4.5770.81%) was significantly greater (Po0.05) than in IDP group (2.2570.72%). Fasting plasma glucose was significantly reduced in MR group (126.474.9 mg/dl) compared with IDP group (152.576.6 mg/dl, Po0.0001) at 6 months but not at 12 months. Controlling for baseline levels, hemoglobin Alc level improved by 0.4970.22% for those receiving MR when compared to IDP group (Po0.05). A greater number of subjects in MR group reduced their use of sulfonylureas (Po0.0001) and metformin (Po0.05) as compared to IDP group. High-sensitivity C-reactive protein (hs-CRP) decreased 26.3% (P1⁄40.019) in MR group compared to 7.06% (P1⁄4 0.338) in IDP group at 6 months. Similar changes were observed at 12 months with MR groups, with hs-CRP decreasing by 25.0% (P1⁄40.019) compared to 18.7% (P1⁄4 0.179) in IDP group. Conclusion: This study demonstrates that MR is a viable strategy for weight reduction in diabetic patients, resulting in beneficial changes in measures of glycemic control and reduction of medications. European Journal of Clinical Nutrition (2005) 59, 411–418. doi:10.1038/sj.ejcn.1602089 Published online 22 December 2004