Effects of probiotic soy milk on lipid panel in type 2 diabetic patients with nephropathy: A double-blind randomized clinical trial

Background: Cardiovascular diseases (CVD) are among the most common complications of diabetes. Lipid abnormalities in diabetic patients are not only related to higher risk of CVD, but also accelerate the progression of diabetic nephropathy. To the best of our knowledge, there is no study that has assessed the effects of probiotic soy milk on lipid profile in type 2 diabetic patients with nephropathy. Objective: The current study was designed to examine the effects of consumption of soy milk containing lactobacillus plantarum A7 compared with conventional soy milk on lipid panel in type 2 diabetic patients with nephropathy. Methods: A total of 44 type 2 diabetic patients with nephropathy were randomly assigned to receive 200 ml/day of either probiotic soy milk (n=22) or conventional soy milk (n=22) for eight weeks, in this randomized double-blind clinical trial. Fasting blood samples were taken at the beginning and after eight weeks of the intervention for analysis of lipid profile and other relevant variables. P values < 0.05 were considered as statistically significant. Results: Consumption of probiotic soy milk for 8 weeks led to an increase in serum genistein (17.6±15.3 vs. 4.5±2.3, p=0.002) and eGFR (15.9±10.8 vs. 3.2±8.4, p<0.001) compared with conventional soy milk. Additionally probiotic soy milk resulted in decreased LDL-cholesterol (-9.2±10.4 vs. -2.2±5.2, p=0.01), total cholesterol (-12.4±4.8 vs. -4.87±14.7, p=0.04), non-HDL cholesterol (-15.3±4.5 vs. -5.9±14.7, p=0.01) and serum TG (-14.6±12.5 vs. -3.9±9.3, p=0.007) compared with control group. We did not detect any significant effect of probiotic soy milk on serum HDL-cholestrol (1.11±3.38 vs. 0.90±2.7, p=0.8) and serum phosphorus (-0.14±0.10 vs. 0.05±0.5, p=0.1). Conclusion: Administration of soy milk containing lactobacillus plantarum A7 in type 2 diabetic patients with nephropathy had beneficial effects on lipid profile and glomerular function, but did not affect HDL-cholesterol. In addition probiotic soy milk did not result in a significant elevation in the serum phosphorus concentration. This trial was registered at http://www.irct.ir as IRCT201601027479N2.