[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431064":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":12,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":12,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":37,"whyStopped":12,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Kentucky","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","NO_INTERVENTION","Participants in this group will have baseline and post-study data collected, including food timing, activity\u002Fsleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). There will be no intervention.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Time-Restricted Feeding (TRF) Group","EXPERIMENTAL","Participants in this group will have baseline and post-study data collected, including food timing, activity\u002Fsleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks.",[18],"Behavioral: Time-Restricted Feeding (TRF)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Time-Restricted Feeding (TRF)","Subjects will be educated about the health benefits of time-restricted feeding (TRF). Each subject in the TRF group will self-select a 10 hour (10h +\u002F- 1hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily meals for the duration of the study.",[14],[26],{"name":27,"affiliation":5,"role":28},"Julie S Pendergast, PhD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Matt Thomas, PhD","CONTACT","(859) 218-6770","jmthomg@uky.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Lexington","Kentucky","40536","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-84.47772,37.98869,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Julie Pendergast","Assistant Professor",[56],{"name":57,"class":58},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100431064","time-restricted-feeding-intervention-in-metabolically-unhealthy-postmenopausal-women-100431064",false,"NCT04893226","Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women","Inclusion Criteria:\n\n* postmenopausal women\n* age 45-65 years\n* prediabetic or have at least 2 features of metabolic syndrome\n\nExclusion Criteria:\n\n* on hormone therapy\n* diabetes\n* heart disease\n* alcohol consumption of \\>2 drinks per day\n* significant circadian disruption\n* having care-taking responsibilities that significantly affect sleep\n* shift work or irregular lifestyle\n* uncontrolled sleep apnea or other uncontrolled sleep disorder\n* extreme early or late chronotypes\n* significant psychiatric disorders\n* taking ADHD medications\n* diagnosed dysregulated eating behaviors\n* smoking \\>5 cigarettes\u002Fday or 30 pack-year history\n* participating in formal weight loss program\n* not weight stable",true,"FEMALE","45 Years","65 Years",{"count":70,"type":71},164,"ESTIMATED","INTERVENTIONAL",[74],"NA","This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.",[77,78],"Metabolic Syndrome","Postmenopausal Symptoms",[80,81,82,83,84,85,86,87,88,89,90],"postmenopause","weight","metabolic risk","glucose","body composition","lipid","sleep","prediabetes","fasting","circadian","inflammation","2025-11-16",{"date":93,"type":94},"2025-11-19","ACTUAL",{"date":96,"type":94},"2021-10-19",{"date":98,"type":71},"2027-01-31",{"name":53,"class":6},1]