Trial reportFrontiers in endocrinology2026
Efficacy of an Eastern Healthy Dietary Pattern-modified ketogenic diet in patients with obesity and polyendocrine metabolic ovarian syndrome.
Trial report in Frontiers in endocrinology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: To evaluate the efficacy and safety of an Eastern Healthy Dietary Pattern (EHDP)-modified ketogenic diet in Chinese patients with obesity and polyendocrine metabolic ovarian syndrome (PMOS; formerly polycystic ovary syndrome [PCOS]) and to provide evidence for a culturally adapted nutritional intervention. Methods: This single-arm, self-controlled study enrolled 55 patients with PMOS and obesity (body mass index [BMI] ≥28 kg/m²) from the Clinical Nutrition Clinic of the Second Affiliated Hospital of Zhejiang Chinese Medical University between February 2024 and September 2025. Participants underwent a 12-week phased dietary intervention. Body composition, metabolic indices, reproductive hormones, and clinical symptoms were assessed before and after the intervention. Results: During the intervention, blood β-hydroxybutyrate concentrations remained within the target range of 0.5-3.0 mmol/L and reached 1.24 ± 0.41 mmol/L at week 12, indicating good adherence. Mean body weight decreased by 9.97 kg (10.63%), body fat mass by 7.53 kg, and visceral fat area by 35.81 cm², whereas skeletal muscle mass decreased by 1.60 kg. The homeostasis model assessment of insulin resistance (HOMA-IR) decreased by 48.8%, and triglyceride concentrations decreased from 1.60 ± 0.91 to 1.08 ± 0.49 mmol/L. Alanine aminotransferase and aspartate aminotransferase concentrations also decreased significantly, whereas low-density lipoprotein cholesterol and small dense low-density lipoprotein cholesterol did not increase significantly. Total testosterone and luteinizing hormone concentrations decreased by 35.8% and 55.5%, respectively, and the luteinizing hormone/follicle-stimulating hormone ratio approached the normal range. Serum 25-hydroxyvitamin D increased from 17.86 ± 3.52 to 23.90 ± 4.12 ng/mL. Clinical symptoms improved, with no clinically significant adverse changes in the assessed safety parameters (all Conclusion: A 12-week EHDP-modified ketogenic diet was associated with improvements in body composition, metabolic indices, reproductive hormones, and clinical symptoms in Chinese patients with PMOS and obesity, without clinically significant safety concerns. This culturally adapted approach may offer a practical nutritional strategy for this population; controlled trials are warranted to confirm these findings. Clinical trial registration: https://www.chictr.org.cn/showproj.html?proj=176830, identifier ChiCTR2200063473.
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