Bacillus subtilis DE111 intake may improve blood lipids and endothelial function in healthy adults

Cardiovascular disease (CVD) is the leading cause of death in the US and worldwide. By 2030 it is anticipated that CVD will claim the lives of more than 24 million people. Throughout the last decade, researchers have investigated the role of the gut microbiota in the development of CVD. Evidence exists for a positive correlation between Bifidobacterium and vascular function, glucose tolerance, and reduced systemic inflammation. Another probiotic species, Bacillus subtilis, has also been found to reduce cholesterol levels in human and animal models. In light of these data, we examined various measures of cardiovascular health after consumption of Bifidobacterium animalis subsp. lactis strain BL04, with and without a cocktail of Escherichia coli-targeting bacteriophages (marketed as PreforPro), Bacillus subtilis strain DE111 or a maltodextrin-based placebo in a healthy human population. In a randomised, double-blind, placebo-controlled 4-week intervention conducted in individuals 18 to 65 years of age with a body mass index of 20 to 34.9, we saw no significant changes in measured CVD parameters among individuals consuming B. lactis with or without bacteriophages. However, B. subtilis supplementation resulted in a significant reduction in total cholesterol relative to baseline measures (-8 mg/dl; P=0.04, confidence interval (CI): -13.40, -0.19), as well as non-high-density lipoprotein-cholesterol (-11 mg/dl; P=0.01, CI: -12.43, -2.07). In addition we observed trending improvements in endothelial function (P=0.05, CI: -0.003, 0.370) and in low-density lipoprotein-cholesterol (P=0.06, CI:-12.29, 0.2864). Strikingly, these effects were seen in a largely healthy population. These data suggest that B. subtilis supplementation may be beneficial for improving risk factors associated with CVD. Further studies in populations of older adults or those with dyslipidaemia and endothelial dysfunction is warranted.