Context: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age.
Objective: This study was designed to evaluate effects of lifestyle modifications and synbiotic supplementation on PCOS.
Design: A randomized (1:1) double-blind, placebo-controlled trial.
Setting: Academic hospital.
Patients or other participants: Overweight and obese women with PCOS were identified according to the Rotterdam criteria. Evaluations were performed at baseline and repeated after 3 months of treatment.
Intervention: Lifestyle modifications in combination with synbiotic supplementation or placebo.
Main outcome measures: Change in body mass index (BMI) and testosterone level.
Results: In the placebo group, a 5% decrease in BMI was accompanied by significant decreases of the waist, hip, and thigh circumferences. The synbiotic group experienced an 8% decrease in BMI, which was significantly greater than that in the control group (P = 0.03) and was accompanied by decreases in the waist, hip, and thigh circumferences. Testosterone did not decrease significantly in the placebo group (decrease of 6%), whereas in the synbiotic group it decreased by 32% (P < 0.0001). The decrease of testosterone was significantly greater in the synbiotic group than in the placebo group (P = 0.016).
Conclusions: Synbiotic supplementation potentiated effects of lifestyle modifications on weight loss and led to significant reduction of serum testosterone.
Trial registration: ClinicalTrials.gov NCT03325023.
Keywords: diet; polycystic ovary syndrome; synbiotic; testosterone.
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