A 7-Week Pilot Clinical Evaluation of Levolar ForteTM, A Mushroom-Based Supplement, on Glycemic, Lipid, and Hepatic Biomarkers in Type 2 Diabetes Mellitus

Abstract

Type 2 diabetes mellitus (T2DM) is present in more than 537 million individuals globally, with increasing prevalence attributed to the global spread of Western dietary lifestyles. While pharmaceutical treatments control the level of glucose in the blood, access is constrained by availability, side effect risks, and expense. Systemic medical practices have employed botanicals and medicinal mushrooms for the regulation of metabolism, but there are very few that have been clinically supported. The purpose of this open-label, single-arm, pre-post intervention pilot investigation was to test the influence of Levolar ForteTM, a proprietary botanical and mushroom-based supplement, on glucose control, lipid profile, and liver enzymes in patients with T2DM. Ten adults with clinically diagnosed T2DM received Levolar ForteTM (Aloha Medicinals Inc., Carson City, NV, USA) at a dose of 3000 mg per day (1500 mg twice per day) for 7 weeks. Fasting plasma glucose (FPG), lipid fractions, and liver enzymes (alanine aminotransferase and aspartate aminotransferase) values were ascertained for each patient at the pre-treatment visit and after the intervention. Paired t tests indicated a decrease in FPG (P = 0.026), total cholesterol (P = 0.002), and non-HDL cholesterol (P = 0.045), with positive trends across other parameters. No adverse events were noted. The implications are that Levolar ForteTM can be a safe, effective adjunct to T2DM treatment, and further validation is indicated in bigger, placebo-controlled studies.