Effects of Synbiotic-Containing Bacillus coagulans (GBI-30) on the Cardiovascular Status of Patients With Polycystic Ovary Syndrome: A Triple-blinded, Randomized, Placebo-controlled Study

Abstract

PurposeDespite the high risk of cardiovascular diseases in women with polycystic ovary syndrome, fewer studies have addressed the improvement of cardiometabolic status of these patients. This study was conducted with the aim of investigating the effects of synbiotic-containing, spore-forming Bacillus coagulans on cardiometabolic indicators, including lipid profile, C-reactive protein, and atherogenic indexes in patients with polycystic ovary syndrome. MethodsIn the present 12-week, triple-blinded, randomized, placebo-controlled clinical trial, 72 women with polycystic ovaries were randomized to receive either 2 g of synbiotic sachet (n = 36) or placebo (n = 36) plus lifestyle modification. Fasting blood samples were taken before and after the intervention. FindingsStatistical analysis was performed in 60 participants with a mean (SD) age of 28.25 (5.98) years who completed the intervention (synbiotic group [n = 34] and placebo group [n = 26]). A significant mean (SD) decrease in C-reactive protein level was observed in the synbiotic group compared with the placebo group (−0.12 [9.57] v. −0.008 [4.69], P = 0.03). No significant differences in mean changes of lipid profile and atherogenic indexes were seen between the 2 groups. Although the estimated mean changes in atherogenic indexes in the synbiotic group indicates a greater reduction than the placebo group, no significant difference was detected. ImplicationsOur 12-week synbiotic intervention improved the inflammatory status in women with polycystic ovaries without affecting lipid profile or atherogenic indexes.