Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial (Publication with Expression of Concern)

The aim of the current study was to assess the effects of probiotic supplementation on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome (PCOS). In a randomized, double-blind, placebo-controlled trial, 60 women with PCOS were randomized to receive probiotic capsule (n=30) or placebo (n=30) for 12 weeks. Consumption of probiotic supplements resulted in a significant reduction in weight (-0.5 +/- 0.4 vs.+0.1 +/- 1.0kg, p=0.004) and BMI (-0.2 +/- 0.2 vs.+0.03 +/- 0.4kg/m(2), p = 0.004) compared with the placebo. In addition, compared with the placebo, probiotic administration was associated with a significant decrease in fasting plasma glucose (-2.4 +/- 8.4 vs.+2.1 +/- 7.0mg/dL, p=0.02), serum insulin concentrations (-2.0 +/- 5.8 vs.+1.6 +/- 5.0IU/mL, p=0.01), homoeostasis model of assessment-insulin resistance (-0.5 +/- 1.4 vs.+0.3 +/- 1.1, p=0.01), homoeostatic model assessment-beta cell function (-7.5 +/- 22.3 vs.+6.3 +/- 21.7, p=0.01), serum triglycerides (-13.3 +/- 51.3 vs.+13.6 +/- 37.1mg/dL, p=0.02) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0.006 +/- 0.01 vs. -0.005 +/- 0.02, p = 0.01). When we adjusted the analysis for baseline values of biochemical parameters, age and baseline BMI, except for QUICKI (p=0.08), other findings did not alter. We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss, markers of insulin resistance, triglycerides and VLDL-cholesterol concentrations.