{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T05:04:15Z","timestamp":1790053455656,"version":"4.0.1"},"reference-count":35,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:00:00Z","timestamp":1790035200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Nutr."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Polycystic ovary syndrome (PCOS) is characterized by insulin resistance and menstrual irregularity. Ketogenic diet (KD) improves glycemic-lipid profiles and reduces inflammation, yet its efficacy on menstrual regularity in PCOS remains unclear. This trial evaluated KD effects on glycemic-lipid metabolism and menstrual restoration in PCOS women.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This single-center, randomized, open-label, parallel-controlled preliminary exploratory trial enrolled 60 Chinese women with PCOS, randomly assigned to ketogenic diet (KD,\n                      <jats:italic>n\u202f=<\/jats:italic>\n                      30) or simulated Mediterranean diet (SMD,\n                      <jats:italic>n\u202f=<\/jats:italic>\n                      30) for 12\u202fweeks. Total daily caloric intake was consistent between the two groups, based on resting energy expenditure (REE) estimated using the Mifflin-St Jeor equation, with a standardized daily energy deficit of 500\u202fkcal. The macronutrient composition differed structurally: KD provided 70\u201375% fat, 15\u201320% protein, and &amp;lt;10% carbohydrates (&amp;lt;50\u202fg\/day), whereas SMD provided 30\u201335% fat, 15\u201320% protein, and 45\u201350% carbohydrates. The primary endpoints were change in HOMA-IR and menstrual regularity. 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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 (\n                      <jats:italic>p<\/jats:italic>\n                      \u202f=\u202f0.006), with a number needed to treat of 3.3. KD produced substantially greater reductions in body weight (\u221216.03 vs. \u22126.03\u202fkg;\n                      <jats:italic>p<\/jats:italic>\n                      \u202f&amp;lt;\u202f0.0001), BMI (\u22126.10 vs. \u22122.23\u202fkg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ;\n                      <jats:italic>p<\/jats:italic>\n                      \u202f&amp;lt;\u202f0.0001), waist circumference (\u221217.23 vs. \u22125.80\u202fcm;\n                      <jats:italic>p<\/jats:italic>\n                      \u202f&amp;lt;\u202f0.0001), and visceral fat area (\u221251.27 vs. \u221213.21\u202fcm\n                      <jats:sup>2<\/jats:sup>\n                      ;\n                      <jats:italic>p<\/jats:italic>\n                      \u202f&amp;lt;\u202f0.0001). 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats: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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fnut.2026.1920489","type":"journal-article","created":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T04:26:18Z","timestamp":1790051178000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy of ketogenic diet on glycemic-lipid metabolism and menstrual regularity in women with polycystic ovary syndrome: a randomized controlled trial"],"prefix":"10.3389","volume":"13","author":[{"given":"Min","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Clinical Nutrition, Yangzhou Maternal and Child Health Care Hospital Affiliated to Yangzhou University","place":["Yangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lingyun","family":"Xie","sequence":"additional","affiliation":[{"name":"Department of Clinical Nutrition, Yangzhou Maternal and Child Health Care Hospital Affiliated to Yangzhou University","place":["Yangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Ma","sequence":"additional","affiliation":[{"name":"Department of Clinical Nutrition, Yangzhou Maternal and Child Health Care Hospital Affiliated to Yangzhou University","place":["Yangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cuijun","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Clinical Nutrition, Yangzhou Maternal and Child Health Care Hospital Affiliated to Yangzhou University","place":["Yangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ya","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Clinical Nutrition, Yangzhou Maternal and Child Health Care Hospital Affiliated to Yangzhou University","place":["Yangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yulu","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Clinical Nutrition, Yangzhou Maternal and Child Health Care Hospital Affiliated to Yangzhou University","place":["Yangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yaru","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Clinical Nutrition, Yangzhou Maternal and Child Health Care Hospital Affiliated to Yangzhou University","place":["Yangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Clinical Nutrition, Yangzhou Maternal and Child Health Care Hospital Affiliated to Yangzhou University","place":["Yangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingjing","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Nutrition, Central Hospital, Tianjin University\/Tianjin Third Central Hospital","place":["Tianjin, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,22]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"1303","DOI":"10.1007\/s00404-024-07353-2","article-title":"Global prevalence of polycystic ovary syndrome in women worldwide: a comprehensive systematic review and meta-analysis","volume":"310","author":"Salari","year":"2024","journal-title":"Arch Gynecol Obstet"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1093\/hropen\/hoad009","article-title":"International evidence-based guideline for the assessment and management of polycystic ovary syndrome 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