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

Abstract

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.

Examining the Gastrointestinal and Immunomodulatory Effects of the Novel Probiotic Bacillus subtilis DE111

“…Therefore, DE111 may be useful in suppressing responses driven by obesity and diet-derived metabolic endotoxemia. This is consistent with our previous observation of improved lipid parameters and endothelial function in DE111-treated individuals, which can result from metabolic dysregulation driven by inflammation [21]. Finally, it should be noted that even within the DE111 group, the responses between individuals were highly variable and the observed differences in immune cell populations was largely driven by a group of responders.…”

“…Although the in vivo viability, safety, and tolerability of several strains of B. subtilis have been assessed in appropriate human populations [17][18][19][20], little is known about other specific benefits these bacteria may convey. We recently demonstrated that four weeks of B. subtilis DE111 supplementation was associated with improved lipid parameters and endothelial function in healthy adults [21]. In addition, several in vitro and animal model studies have suggested that B. subtilis may modulate the mucosal immune system via production of antimicrobial peptides, exopolysaccharides, and quorum-sensing molecules, as well as through favorable modifications to the gut microbiota [22][23][24].…”

Examining the Immunomodulatory Effects of the Novel Probiotic Bacillus subtilis de111

“…Therefore, DE111 may be useful in suppressing responses driven by obesity and diet-derived metabolic endotoxemia. This is consistent with our previous observation of improved lipid parameters and endothelial function in DE111 treated individuals, which can result from metabolic dysregulation driven by inflammation (20). Finally, it should be noted that even within the DE111 treatment group, the responses between individuals were highly variable and the observed differences in immune cell populations was largely driven by a group of responders.…”

“…Participants arrived at the FNCRL for their baseline visit to undergo sample collections (blood and stool) and analysis procedures (weight/height, blood pressure, pulse wave and endothelial function analysis, gastrointestinal symptom screening, and medical health history questionnaire) as previously described (20). Whole blood was collected from the antecubital vein and analyzed for metabolic and lipid parameters using a Piccolo Xpress (Abaxis; Union City, CA) with Piccolo Metlyte (20). Stool samples were collected by participants in studyprovided collection containers and stored under refrigeration prior to being returned to the clinic.…”

“…Although the in vivo viability, safety, and tolerability of several strains of B. subtilis have been assessed in appropriate human populations(16)(17)(18)(19), little is known about other specific benefits these bacteria may convey. We recently demonstrated that four weeks of B. subtilis DE111 supplementation was associated with improved lipid parameters and endothelial function in healthy adults(20). In addition, several in vitro and animal model studies have suggested that B. subtilis may modulate the mucosal immune system via production of antimicrobial peptides, exopolysaccharides, and quorum sensing molecules, as well as through favorable modifications to the gut microbiota(21)(22)(23).…”