A Randomized Placebo Controlled Clinical Trial of a Metabolic Shifting Probiotic, Sugar Shift, for the Treatment of T2DM

Abstract

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by hyperglycemia, insulin resistance and chronic inflammation. Probiotics have been claimed effective in the management of obesity and type 2 diabetes mellitus. BiotiQuest™ Sugar Shift is a symbiotic formulation rationally designed for the endogenous conversion of glucose and fructose to support restoration of the human gut microbiota, modulation of intestinal glucose, and the production of anti-inflammatory metabolites. We report the results of a 12-week, double blind, placebo-controlled study designed to evaluate Sugar Shift in Cuban T2DM patients. Clinical parameters, including fasting and 2h post-prandial glucose, hemoglobin A1c, a lipid panel, insulin, creatinine, and serum lipopolysaccharide levels were assessed. Microbiome composition was assessed by 16S amplicon sequencing of the variable region V3-V4 of the 16S rRNA gene. Metabolic biomarkers were inferred from microbiome data by Kruskal-Wallis H test and LEfSe. Fasting glucose, Insulin, and serum LPS levels decreased significantly at day 84 as compared to day 1 in the treated group and to control group. Hb A1c remained stable in the treatment group as compared to the controls but not show significant improvement in the study period. Microbiome analysis showed significant increase in Chao1 alpha diversity in the treated group between day 1 and day 84. Taxonomic and functional biomarkers revealed significant differences between the Day 1 and Day 84 microbiome profiles in the treatment group, primarily associated with acetate, propionate, and butyrate production. Our results indicate that Sugar Shift can be a suitable adjunct therapy to standard of care therapy in the management of T2DM based upon the improvement in key inflammatory and insulin resistance markers. These results were interpreted as an indication of favorable microbiome changes during the course of the treatment for 12 weeks