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 (4.57+/-0.81%) was significantly greater (P<0.05) than in IDP group (2.25+/-0.72%). Fasting plasma glucose was significantly reduced in MR group (126.4+/-4.9 mg/dl) compared with IDP group (152.5+/-6.6 mg/dl, P<0.0001) at 6 months but not at 12 months. Controlling for baseline levels, hemoglobin Alc level improved by 0.49+/-0.22% for those receiving MR when compared to IDP group (P<0.05). A greater number of subjects in MR group reduced their use of sulfonylureas (P<0.0001) and metformin (P<0.05) as compared to IDP group. High-sensitivity C-reactive protein (hs-CRP) decreased -26.3% (P = 0.019) in MR group compared to -7.06% (P = 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% (P = 0.019) compared to -18.7% (P = 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.

RCT Entities:   Population Interventions Outcomes