Table 1_Efficacy of ketogenic diet on glycemic-lipid metabolism and menstrual regularity in women with polycystic ovary syndrome: a randomized controlled trial.docx

Secondary endpoints included anthropometric parameters, glycemic markers, lipid profiles, hormonal levels, and safety parameters. Nutritional ketosis was verified by daily urinary ketone testing and weekly blood ketone monitoring, and dietary adherence was assessed using a standardized compliance score.</p>Results<p>This study showed that improvements in body weight, waist circumference, and visceral fat area in PCOS patients were positively correlated with reductions in fasting insulin (FINS) and triglycerides (TG).

Compared with SMD, the KD group demonstrated significantly greater improvements in fasting insulin, HOMA-IR, and triglycerides, and these differences remained significant after adjustment for baseline values using analysis of covariance (ANCOVA). Menstrual regularity was restored in 96.7% of KD participants versus 66.7% in the SMD group (p = 0.006), with a number needed to treat of 3.3. KD produced substantially greater reductions in body weight (−16.03 vs. −6.03 kg; p < 0.0001), BMI (−6.10 vs. −2.23 kg/m²; p < 0.0001), waist circumference (−17.23 vs. −5.80 cm; p < 0.0001), and visceral fat area (−51.27 vs. −13.21 cm²; p < 0.0001).

Neither diet adversely affected hepatic or renal function or protein status; moreover, KD reduced ALT and AST more than SMD. Both diets demonstrated favorable safety profiles with no serious adverse events and 100% completion rate.</p>Conclusion<p>During the 12-week short-term intervention, the KD dietary intervention was superior to the SMD dietary intervention in improving insulin resistance and restoring menstrual regularity in women with PCOS.

KD is suitable for acute metabolic intervention given its pronounced weight reduction and insulin sensitivity improvement; however, these findings were obtained in a single-center, exploratory trial and require validation in multi-center, larger-scale randomized controlled trials, and its long-term population impact and reproductive outcomes remain to be further investigated. SMD offers anti-inflammatory advantages and safety profiles conducive to long-term health maintenance.

Therefore, a sequential strategy of initial KD followed by SMD transition is recommended to achieve sustained metabolic benefits and optimize fertility outcomes.</p>