Diabetes mellitus is a metabolic disease characterized by the presence of high blood glucose (hyperglycemia) either because insulin production is insufficient due to autoimmune destruction of insulin-secreting β cells or pancreatitis-type 1 diabetes-and/or the body's cells do not respond properly to insulin (ie, insulin resistance), type 2 diabetes. 1 The disease makes an important contribution to morbidity, loss of well-being, and mortality worldwide. Currently, approximately 350 million people have diabetes mellitus worldwide, and this number is believed to reach almost 500 million people by 2030 (IDF, Diabetes Atlas). Among the two forms of diabetes, type 2 diabetes mellitus is the most common form of the disease and accounts for more than 90% of total diabetes worldwide. Worsening the global situation, there is a growing body of evidence linking type 2 diabetes mellitus with cardiovascular disease and dementia (eg, Alzheimer's disease). 2 A growing number of type 2 diabetic patients do not respond properly
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.
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