[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584124":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":28,"centralContacts":45,"locations":51,"responsibleParty":69,"collaborators":28,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":28,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":54,"whyStopped":28,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Erlangen-Nürnberg Medical School","OTHER",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Metabolic syndrome - alternate day fasting","EXPERIMENTAL","Patients with metabolic syndrome who undergo alternate-day fasting in addition to regular advice on the mediterranean diet",[13],"Other: Alternate day fasting",{"label":15,"type":10,"description":16,"interventionNames":17},"Metabolic syndrome - time restricted eating","Patients with metabolic syndrome who undergo time restricted eating in addition to regular advice on the mediterranean diet",[18],"Other: Time restricted eating",{"label":20,"type":10,"description":21,"interventionNames":22},"Metabolic syndrome - time restricted eating plus high-intensity interval training","Patients with metabolic syndrome who undergo time restricted eating plus high-intensity interval training in addition to regular advice on the mediterranean diet",[18,23],"Other: High-intensity interval training",{"label":25,"type":26,"description":27,"interventionNames":28},"Metabolic syndrome - controls","NO_INTERVENTION","Patients with metabolic syndrome exclusively receiving regular advice on the mediterranean diet",null,{"label":30,"type":26,"description":31,"interventionNames":28},"Healthy - controls","Healthy controls exclusively receiving regular advice on the mediterranean diet",[33,37,41],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Alternate day fasting","Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day.",[9],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Time restricted eating","Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.",[15,20],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":28},"High-intensity interval training","Patients participate in high-intensity interval training.",[20],[46],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Prof. Dr. med. Yurdagül Zopf","CONTACT","0049091318545220","yurdaguel.zopf@uk-erlangen.de",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen","RECRUITING","Erlangen","Bavaria","91054","Germany","DE",{"type":61,"coordinates":62},"Point",[63,64],11.00783,49.59099,{"lat":64,"lon":63},[67],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":68},"hectorcenter.m1@uk-erlangen.de",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","yurdagül zopf","Professor of Integrative Medicine with a Focus on Nutritional Medicine (W3), Director of the Hector Center for Nutrition, Exercise, and Sports","100584124","effects-of-intermittent-fasting-and-exercise-on-inflammation-metabolism-and-the-microbiome-in-metabolic-syndrome-100584124",false,"NCT06885255","Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome","Effects of Intermittent Fasting and Its Combination with High-Intensity Interval Training on Inflammatory and Metabolic Markers, As Well As the Microbiome in Patients with Metabolic Syndrome: a Randomized Controlled Pilot Study","FIT","Inclusion Criteria:\n\n* Written consent to participate in the study.\n* Persons aged 18 years and older.\n* Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.\n\nExclusion Criteria:\n\n* Pregnant or nursing individuals.\n* Cardiovascular diseases or orthopedic restrictions that prevent exercise.\n* Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks).\n* Body weight greater than 200 kg (maximum capacity of training equipment).\n* Individuals with mental illnesses that may impair their ability to understand or participate in the study.",true,"ALL","18 Years","80 Years",{"count":86,"type":87},250,"ESTIMATED","INTERVENTIONAL",[90],"NA","The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is:\n\nDoes intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome?\n\nParticipants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.",[93,94],"Metabolic Syndrome","Obesity and Obesity-related Medical Conditions",[96,97,98,99,100],"obesity","metabolic syndrome","high-intensity interval training","inflammation","intermittent fasting","2025-03-17",{"date":103,"type":104},"2025-03-20","ACTUAL",{"date":106,"type":104},"2023-06-01",{"date":108,"type":87},"2026-03",{"name":5,"class":6},1]