Six-month randomized, placebo controlled trial of synbiotic supplementation in women with polycystic ovary syndrome undergoing lifestyle modifications.

Abstract

PURPOSE: To determine whether long-term administration of synbiotics affects clinical, endocrine and metabolic aspects of polycystic ovary syndrome (PCOS) in overweight and obese subjects undergoing intensive lifestyle modifications. METHODS: During six-month trial, all subjects underwent intensive lifestyle modifications (diet and exercise). The subjects were randomized (1:1) to receive synbiotic supplementation (Synbiotic Group) or placebo (Placebo Group). RESULTS: Subjects in the Placebo Group and the Synbiotic Group experienced significant reduction of BMI (- 8% and - 11%, respectively; both at P < 0.0001) and body fat percentage (- 11% and - 14%, respectively; both at P < 0.0001). These effects were statistically comparable for both groups. Total testosterone was not significantly changed in the Placebo Group (- 5%, P = 0.41) while it greatly declined in the Synbiotic Group (- 40%; P < 0.0001); the difference between these groups was significant (P = 0.0002). Synbiotic supplementation was superior to placebo in reducing LH (- 21%; P = 0.047), total cholesterol (- 6%; P = 0.002), low-density lipoprotein cholesterol (- 6%; P = 0.044), triglycerides (- 29%; P = 0.049), LPS (- 23%; P = 0.001) and LPS-binding protein (- 21%; P = 0.001). CONCLUSIONS: Synbiotic supplementation led to a marked improvement of several key clinical and laboratory aspects of PCOS including an improvement of hyperandrogenism, lipid profile, and markers of endotoxemia. TRIAL REGISTRATION: Clinical Trial Registration Number: NCT03325023 (URL, clinicaltrials.gov; date of registration 10/26/2017).