[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Joanna Bajerska\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100531835","the-impact-of-time-restricted-eating-on-the-outcomes-associated-with-polycystic-ovary-syndrome-100531835",false,"NCT06204965","The Impact of Time-restricted Eating on the Outcomes Associated With Polycystic Ovary Syndrome (Polyendocrine Metabolic Ovarian Syndrome)","The Impact of Time-restricted Eating on the Composition of the Intestinal Microbiota and Metabolic and Neurohormonal Parameters of Women With Polycystic Ovary Syndrome","Eligible participants will be women aged 18 to 40 years with a BMI in the range of 25 - 40 kg\u002Fm² with a diagnosis of PMOS confirmed by appropriate medical documentation according to the updated 2023 Rotterdam criteria \\[14\\]. The following exclusion criteria will be applied:\n\n* use of medications affecting carbohydrate or lipid metabolism, or medications influencing body weight, within the previous 3 months (assessed during a medical interview conducted by the recruiting gynecologist);\n* use of antibiotics, probiotics, and\u002For prebiotics within the previous 3 months;\n* smoking within the previous 3 months or alcohol consumption \\>100 g\u002Fweek;\n* participation in competitive sports;\n* significant body weight fluctuations (\\>5%) during the 3 months preceding study enrolment;\n* pregnancy or breastfeeding.","FEMALE","18 Years","40 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Polyendocrine Metabolic Ovarian Syndrome (PMOS), previously known as PCOS, is a common endocrine disorder associated with metabolic, reproductive, and hormonal abnormalities. Growing evidence suggests that time-restricted eating (TRE) may improve body weight regulation, insulin sensitivity, hormonal balance, and menstrual function in women with PMOS. However, the mechanisms underlying these benefits remain unclear, particularly regarding the role of the gut microbiota and neurohormonal pathways.\n\nThis randomized controlled trial will investigate whether combining an 8-hour TRE regimen with Healthy Eating Plate dietary recommendations provides greater benefits than dietary recommendations alone. Women aged 18-40 years with PMOS and overweight or obesity will participate in an 8-week intervention. The study will assess changes in gut microbiota composition, microbial metabolites, metabolic health, hormonal profile, neurohormonal markers, and body composition.\n\nThe study is expected to provide novel insights into the interactions between meal timing, gut microbiota, neuroendocrine regulation, and clinical manifestations of PMOS, contributing to the development of more effective and sustainable dietary strategies for this condition.",[27],"Polycystic Ovary Syndrome",[29,30,31,27,32],"Intermittent Fasting","Microbiota","Neurotransmitter Agents","Polyendocrine Metabolic Ovarian Syndrome","NOT_YET_RECRUITING","2026-09-29",{"date":36,"type":37},"2026-10-05","ACTUAL",{"date":39,"type":21},"2027-01-09",{"date":41,"type":21},"2028-03-31",{"name":43,"class":44},"Joanna Bajerska","OTHER",""]