Objective: To assess the efficacy of a very low-calorie ketogenic diet (VLCKD) method versus a Mediterranean low-calorie diet (LCD) in obese PCOS women of a reproductive age. Design: Randomized controlled open label trial. The treatment period was 16 weeks; VLCKD for 8 weeks then LCD for 8 weeks, according to the Pronokal® method (experimental group; n=15) versus Mediterranean LCD for 16 weeks (control group; n=15). Ovulation monitoring was carried out at baseline and after 16 weeks, while a clinical exam, bioelectrical impedance analysis (BIA), anthropometry, and biochemical analyses were performed at baseline, at week 8, and at week 16. Results: BMI decreased significantly in both groups, and to a major extent in the experimental group (-13.7% vs -5.1%, p=0.0003). Significant differences between the experimental and the control groups were also observed in the reduction of waist circumference (-11.4% vs -2.9%), BIA-measured body fat (-24.0% vs -8.1%), and free T (-30.4% vs -12.6%) after 16 weeks (p=0.0008, p=0.0176, and p=0.0009, respectively). HOMA-IR significantly decreased only in the experimental group (p=0.0238), but without significant differences with respect to the control group (-23% vs -13.2%, p>0.05). At baseline, 38.5% participants in the experimental group and 14.3% participants in the control group had ovulation, which increased to 84.6% (p=0.031) and 35.7% (p>0.05) at the end of the study, respectively. Conclusion: In obese PCOS patients, 16-weeks of VLCKD protocol with the Pronokal® method was more effective than Mediterranean LCD in reducing total and visceral fat, and in ameliorating hyperandrogenism and ovulatory dysfunction.
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