Efficient Weight Loss and Type II Diabetes Control in Overweight and Obese Patients Consuming the Probiotic Bacillus Subtilis DG101: A Randomized Double-Blind Placebo-Controlled Study

Abstract

Objective: Obesity is a worldwide endemic disease with limited options for treatment. Studies have indicated that the probiotic Bacillus subtilis can reduce weight gain and serum lipid levels in animal models. However, there are no publications showing positive results on the anti-obesity effect in humans. Here, we investigated the anti-obesity effect of the probiotic B. subtilis DG101 (i.e., reductions in weight, corporal fat content, and BMI) on overweight/obese subjects and the management of their HbA1c and insulin values. Design: A randomized, double-blinded, placebo-controlled study. Methods: A total of 294 subjects were divided into two groups according to sex. The subjects were randomly assigned to receive a daily dose of the probiotic B. subtilis DG101 or pure water (placebo) in all cases combined with a low-caloric/low-fat diet for 12 weeks. Weight, fat percentage, and BMI were measured, as well as HbA1c and insulin levels before and after the intervention. Results: The probiotic B. subtilis DG101 significantly reduced weight, fat percentage, and BMI after 12 weeks of the intervention compared to the placebo (p<0.05). There was a significant reduction of HbA1c and insulin levels between the groups (p<0.05). Conclusions: Ingestion of the probiotic B. subtilis DG101 as an adjuvant in the anti-obesity therapy compared with placebo for 12 weeks significantly reduce obesity related parameters. Our finding of lower HbA1c and insulin levels in pre-diabetic and diabetic patients during ingestion of the probiotic B. subtilis DG101 validated one of our previous reports.