A Clinical Trial on Anti-diabetic Efficacy of Submerged Culture Medium of Ceriporia lacerata Mycelium

Background: Increased glucose level and insulin resistance are major factors in Type 2 diabetes mellitus (T2M), which is chronic and debilitating disease worldwide. Submerged culture medium of Ceriporia lacerata mycelium (CLM) is known to have glucose lowering effects and improving insulin resistance in a mouse model in our previous studies. The main purpose of this clinical trial was to evaluate the functional efficacy and safety of CLM in subjects with impaired fasting blood sugar or mild T2D for 6-12 weeks. Methods: A total of 72 subjects with glucose intolerance or mild T2D were participated in a randomized, double-blind, placebo-controlled clinical trial. All subjects were randomly assigned into the CLM group or placebo group. Fasting blood glucose (FBG), HbA1c, insulin, C-peptide, HOMA-IR, and HOMA-IR by C-peptide were used to assess the anti-diabetic efficacy of CLM for 6-12 weeks. Results: In this study, the effectiveness of CLM on lowering all the anti-diabetic indicators (C-peptide levels, insulin, and FBG) was confirmed. CLM significantly elicited anti-diabetic effects after 6-12 weeks of ingestionwithout showing any side effects in both groups of subjects. After the CLM treatment, FBG levels were effectively dropped by 63.9% (ITT), while HOMA-IR level of in the CLM group with FBG >110 mg/dL showed a marked decrease by 34% up to 12 weeks. Remarkably, the effect of improving insulin resistance was significantly increased in the subgroup of subjects with insulin resistance, exhibiting effective reduction at 6 weeks (42.5%) and 12 weeks (61%), without observing a recurrence or hypoglycemia. HbA1c levels were also decreased by 50% in the subjects with reduced indicators. Additionally, it is noteworthy that the levels of insulin and C-peptide were significantly reduced despite the CLM group with FBG >110 mg/dL. No significant differences were detected in the other parameters (lipids, blood, serum, and blood pressure) after 12 weeks. Conclusion: The submerged culture medium of CLM showed clinical efficacy in the improvement of FBG, insulin, C-peptide, HbAc1, and HOMA-index. Thiswork could guide the new treatment pathway of diabetes in a non-invasive manner using a microbiome-based anti-diabetic ingredient to surge global diabetic epidemic.