Pilot study: impact of a probiotic nutritional supplement on biomarkers of metabolic syndrome in type 2 diabetes

Background: The probiotic nutritional supplement BeaT-2 is composed of co-existing lactobacillae. The purpose of this study was to investigate the impact of the supplement vs. placebo on glycemic control and on biomarkers of inflammation, insulin resistance and beta-cell dysfunction. Methods: A total of 40 Patients with type 2 diabetes (31 male, 9 female, age: 65.5 +/- 8.0 yrs, BMI: 33.6 +/- 5.5 kg/m(2), HbA1(c): 7.2 +/- 0.9 %) were included into the study. They were randomized to receive 2 capsules of either BeaT-2 or placebo once daily for 6 weeks. Observation parameters were time in normoglycemia and biomarkers of glycemic control, beta-cell function, insulin resistance and chronic systemic inflammation. Results: Between weeks 0 - 2 and 5 - 6, time in range was stable with BeaT-2 (-1 %), while it slightly impaired with placebo (-4 %, n.s.). Significant improvements vs. baseline with BeaT-2, but not with placebo were seen after 6 weeks for most biomarkers (BeaT-2 vs. placebo, HbA1(c):-0.3 % vs. 0.1 %, fasting glucose:-14 % vs. +8 %, insulin:-17 % vs. +14 %, HOMA-IR:-26 % vs. +21 %, intact proinsulin:-40 % vs.-2 %, adiponectin: +8 % vs.-8 %; all p < 0.05; hsCRP:-31 % vs. +27 %, n.s.). Changes observed in lipid profiles and other parameters of metabolic syndrome were more favorable with BeaT-2 than placebo. No differences were seen with respect to adverse events. Conclusion: Several results observed with BeaT-2 were indicative for improvements in the cardiometabolic situation. It may be a valuable supplement to any treatment in type 2 diabetes.