[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531835":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":64,"studyPopulation":54,"armGroups":65,"interventions":76,"overallOfficials":82,"centralContacts":87,"locations":99,"responsibleParty":130,"collaborators":54,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":54,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":54,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":158,"whyStopped":54,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Poznan University of Life Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":54},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change in composition of the intestinal microbiota","Participants will be asked to provide stool samples at baseline and at the final visit and will receive containers with preservative liquid. Bacterial DNA will be isolated from the provided stool samples using the QIAmp Fast DNA Stool Mini Kit. Then, the DNA will be properly secured and sent to an external company, Genomed S.A. (Warsaw, Poland), where microbiota assessment will be carried out using 16S rRNA gene sequencing targeting the V3-V4 region.","Week 0 (pre-intervention) - week 8 (post-intervention)",{"measure":14,"description":15,"timeFrame":12},"Change in lipopolysaccharide concentration in blood","Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. Serum lipopolysaccharide (LPS) concentrations will be assessed using an enzyme-linked immunosorbent assay (ELISA).",{"measure":17,"description":18,"timeFrame":12},"Change in Short Chain Fatty Acids concentration in stool","Participants will be asked to provide stool samples at baseline and at the final visit and will receive containers with preservative liquid. Quantitative and qualitative determination of short-chain fatty acids in feces will be performed by gas chromatography with flame ionization detection (GC-FID). The research will be carried out at the Department of Bromatology, Poznan University of Medical Sciences.",[20,23,27,30,33,36,39,42,45,48,51],{"measure":21,"description":22,"timeFrame":12},"Change in energy consumption","Dietary intake will be assessed using a validated 72-item Semi-Quantitative Food Frequency Questionnaire (72-item SQ-FFQ) available on the DietTools4U platform and a 3-day dietary record (two weekdays and one weekend day). The use of these complementary methods will enable both the assessment of habitual dietary patterns and the detailed evaluation of recent food intake.",{"measure":24,"description":25,"timeFrame":26},"Change in body composition","Body composition will be measured using dual-energy X-ray absorptiometry (DXA) as a method that uses the phenomenon of weakening the beam of ionizing radiation passing through tissues of various densities. This method is safe and non-invasive. The mass of adipose tissue, including visceral fat tissue, the mass of lean tissue are measured (expressed in the same unit - kilograms)","Week 0 (pre-intervention), week 4, week 8 (post-intervention)",{"measure":28,"description":29,"timeFrame":12},"Change in glucose metabolism - glucose concentration","Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. The glucose will be determined using standard enzymatic colorimetric methods on an automated biochemical analyzer in a certified external diagnostic laboratory (expressed in the unit - mmol\u002FL).",{"measure":31,"description":32,"timeFrame":12},"Change in glucose metabolism - insulin concentration","Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. The insulin concentration will be performed using the ELISA enzyme-linked immunosorbent assay (expressed in the unit - μIU\u002FmL).",{"measure":34,"description":35,"timeFrame":12},"Change in glucose metabolism - Homeostatic Model Assessment of Insulin Resistance","Insulin resistance will be evaluated using the Homeostasis ModelAssessment Method. The HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) will be calculated using the following formula: HOMA - IR = fasting glucose \\[mmol\u002FL\\] × fasting insulin \\[μIU\u002FmL\\]\u002F22.5",{"measure":37,"description":38,"timeFrame":12},"Change in lipid profile","Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. Total cholesterol (T-C), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglycerides concentrations will be using standard enzymatic colorimetric methods on an automated biochemical analyzer in a certified external diagnostic laboratory. The nonHDL-C parameter will be calculated using the formula: nonHDL-C = T-C - HDL-C (expressed in the same unit - mg\u002Fdl or mmol\u002Fl).",{"measure":40,"description":41,"timeFrame":12},"Change in selected hormonal parameters","Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. Hormonal parameters (FSH, LH, testosterone, SHBG), will be performed using the ELISA enzyme-linked immunosorbent assay (expressed in the same unit - pg\u002Fml)",{"measure":43,"description":44,"timeFrame":26},"Change in circumferences","Waist and hip measurements will be taken using an elastic tape. Waist circumference measurement - the tape is placed horizontally or slightly obliquely halfway between the lower edge of the ribs and the upper crest of the ilium. Measurement performed during apnea.",{"measure":46,"description":47,"timeFrame":26},"Change in body weight","Body weight measurement in a standing position, without shoes, in light clothing, on an electronic scale with an accuracy of 0.1 kg.",{"measure":49,"description":50,"timeFrame":26},"Change in bone density","Bone density will be measured using dual-energy X-ray absorptiometry (DXA) as a method that uses the phenomenon of weakening the beam of ionizing radiation passing through tissues of various densities. This method is safe and non-invasive.",{"measure":52,"description":53,"timeFrame":12},"Change in neurohormonal status","Blood will be collected four times from the antecubital vein on an empty stomach, into test tubes with clotting granules (a single sample will amount to a total of 18 ml). The serum will be obtained by centrifugation of a venous blood clot. Kisspeptin and gamma-aminobutyric acid concentrations will be performed using the ELISA enzyme-linked immunosorbent assay.",null,{"allocation":56,"interventionModel":57,"interventionModelDescription":58,"primaryPurpose":59,"observationalModel":54,"timePerspective":54,"maskingInfo":60},"RANDOMIZED","PARALLEL","Women with Polycystic Ovary Syndrome (n=52), aged 18-40.","TREATMENT",{"masking":61,"maskingDescription":54,"whoMasked":62},"SINGLE",[63],"OUTCOMES_ASSESSOR","Polyendocrine Metabolic Ovarian Syndrome (PMOS), formerly referred to as Polycystic Ovary Syndrome (PCOS), affects a substantial proportion of women of reproductive age and is characterized by reproductive, endocrine, and metabolic disturbances. In addition to hormonal dysregulation involving the hypothalamic-pituitary-ovarian axis, women with PMOS frequently experience obesity, insulin resistance, hyperinsulinemia, menstrual irregularities, and impaired fertility. Recent research indicates that the gut microbiota and the gut-brain axis may play important roles in the development and progression of the syndrome. Gut-derived metabolites, including short-chain fatty acids, lipopolysaccharides, and neuroactive compounds such as GABA, may influence both metabolic and reproductive functions.\n\nTime-restricted eating (TRE), an eating pattern that limits food intake to a specific daily time window without necessarily restricting calories, has emerged as a promising intervention for individuals with metabolic disorders. Previous studies suggest that TRE may improve insulin sensitivity, glucose metabolism, lipid profile, body weight, and reproductive outcomes in women with PMOS. Furthermore, evidence from both human and animal studies indicates that TRE may beneficially alter the composition and diversity of the gut microbiota. Despite these findings, the biological mechanisms linking meal timing, gut microbiota changes, neurohormonal regulation, and clinical improvements in PMOS remain insufficiently understood.\n\nTo address this knowledge gap, this study has been designed as a two-arm randomized controlled trial involving women aged 18 to 40 years with PMOS and a BMI between 25 and 40 kg\u002Fm². Participants will be randomly assigned to either a control group following Healthy Eating Plate recommendations without meal-timing restrictions or an intervention group following the same dietary recommendations combined with a 16:8 TRE regimen, restricting food intake to an 8-hour daily eating window. The intervention will last eight weeks.\n\nThe primary objective is to determine whether TRE can induce favorable changes in intestinal microbiota composition and microbial metabolites. Secondary outcomes include changes in glucose and lipid metabolism, insulin resistance, hormonal profile, neurohormonal markers such as kisspeptin and GABA, anthropometric measurements, body composition, and energy intake. Comprehensive assessments will include blood analyses, stool microbiota sequencing, metabolic and hormonal measurements, dietary intake evaluation, and physical activity assessment.\n\nA major strength of the study is its ability to isolate the effect of meal timing because both groups receive identical dietary quality recommendations. This design allows researchers to evaluate whether the timing of food consumption independently contributes to improvements in PMOS-related outcomes. By integrating microbiological, metabolic, and neuroendocrine assessments, the trial is expected to provide a comprehensive understanding of the gut microbiota-brain-reproductive axis in PMOS.\n\nThe researchers anticipate that this will be one of the largest studies examining TRE in women with PMOS. The findings may help clarify the mechanisms through which TRE influences metabolic and reproductive health and support the development of evidence-based, practical, and sustainable dietary recommendations for women affected by this condition.",[66,72],{"label":67,"type":68,"description":69,"interventionNames":70},"Time-restricted eating group (TRE group)","EXPERIMENTAL","Participants in the TRE group will be instructed to consume all foods and energy-containing beverages between 9:00 a.m. and 5:00 p.m. (8-hour eating window) and fast for the remaining 16 hours until the following day (a 16:8 protocol). Participants randomized to the intervention group will receive the same dietary recommendations but will additionally be instructed to follow a time-restricted eating (TRE) regimen.",[71],"Behavioral: Time-restricted eating",{"label":73,"type":74,"description":75,"interventionNames":54},"Non-fasting group","NO_INTERVENTION","Participants assigned to the control group will receive dietary advice based on the Healthy Eating Plate model and will be instructed to consume their diet ad libitum, without prescribed energy restriction.",[77],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":54},"BEHAVIORAL","Time-restricted eating","Time-restricted eating (TRE) is a dietary pattern where food intake is restricted to 8 hours of the day with no limitation on nutrient quality or quantity. Participants assigned to the intervention group will eat their usual diet from 9:00 a.m. to 5:00 p.m., and then fast until the next day (protocol 8\u002F16). During the 16-hour fast, only hot and cold drinks will be allowed, i.e. coffee, tea or tea and water, but all products and dishes with energy value (including coffee cream, sweet teas, alcohol, snacks, etc.) will be prohibited. The TRE protocol will be implemented 7 days a week for a period of 3 months (12 weeks).",[67],[83],{"name":84,"affiliation":85,"role":86},"Agata Chmurzyńska, Prof.","Department of Human Nutrition and Dietetics, Poznań University of Life Sciences","STUDY_CHAIR",[88,94],{"name":89,"role":90,"phone":91,"phoneExt":92,"email":93},"Joanna Bajerska, Assoc. Prof.","CONTACT","8466056","+ 48 61","Joanna.bajerska@up.poznan.pl",{"name":95,"role":90,"phone":96,"phoneExt":97,"email":98},"Joanna M Pieczyńska-Zając, M.Sc.","660950786","+48","joanna.pieczynska@up.poznan.pl",[100],{"facility":101,"status":54,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"Poznań University of Life Sciences","Poznan","Greater Poland Voivodeship","60-637","Poland","PL",{"type":108,"coordinates":109},"Point",[110,111],16.92993,52.40692,{"lat":111,"lon":110},[114,115,116,118,120,122,124,126,128],{"name":89,"role":90,"phone":91,"phoneExt":92,"email":93},{"name":95,"role":90,"phone":96,"phoneExt":97,"email":98},{"name":89,"role":117,"phone":54,"phoneExt":54,"email":54},"PRINCIPAL_INVESTIGATOR",{"name":95,"role":119,"phone":54,"phoneExt":54,"email":54},"SUB_INVESTIGATOR",{"name":121,"role":119,"phone":54,"phoneExt":54,"email":54},"Karolina Łagowska, PhD",{"name":123,"role":119,"phone":54,"phoneExt":54,"email":54},"Aleksandra Bykowska-Derda, PhD",{"name":125,"role":119,"phone":54,"phoneExt":54,"email":54},"Paweł Antoni Kołodziejski, Prof.",{"name":127,"role":119,"phone":54,"phoneExt":54,"email":54},"Ewa Pruszyńska-Oszmałek, PhD",{"name":129,"role":119,"phone":54,"phoneExt":54,"email":54},"Sławomira Drzymała-Czyż, PhD",{"type":131,"investigatorFullName":132,"investigatorTitle":133,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"SPONSOR_INVESTIGATOR","Joanna Bajerska","Associate Professor","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":145,"type":146},60,"ESTIMATED","INTERVENTIONAL",[149],"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.",[152],"Polycystic Ovary Syndrome",[154,155,156,152,157],"Intermittent Fasting","Microbiota","Neurotransmitter Agents","Polyendocrine Metabolic Ovarian Syndrome","NOT_YET_RECRUITING","2026-09-29",{"date":161,"type":162},"2026-10-05","ACTUAL",{"date":164,"type":146},"2027-01-09",{"date":166,"type":146},"2028-03-31",{"name":132,"class":6},1]