[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584124":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":65,"studyPopulation":65,"armGroups":72,"interventions":96,"overallOfficials":65,"centralContacts":109,"locations":115,"responsibleParty":133,"collaborators":65,"id":137,"slug":65,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":144,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":65,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":118,"whyStopped":65,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"University of Erlangen-Nürnberg Medical School","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":65},[9],{"measure":10,"description":11,"timeFrame":12},"hsCRP","High sensitivity C-reactive protein in mg\u002Fl.","From enrollment to the end of intervention at 3 months.",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62],{"measure":15,"description":16,"timeFrame":12},"inflammatory markers and metabolic markers","Determination of inflammatory markers and metabolic markers in blood (e.g., sICAM-1, IGF-1, β-hydroxybutyrate, estrogens, androgens).",{"measure":18,"description":19,"timeFrame":12},"waist circumference","Measurement of waist circumference in centimeters (cm).",{"measure":21,"description":22,"timeFrame":12},"fasting blood glucose","Measurement of fasting blood glucose in milligrams per deciliter (mg\u002FdL).",{"measure":24,"description":25,"timeFrame":12},"triglycerides","Measurement of triglycerides in milligrams per deciliter (mg\u002FdL).",{"measure":27,"description":28,"timeFrame":12},"cholesterol","Measurement of cholesterol (total, LDL, HDL) in milligrams per deciliter (mg\u002FdL).",{"measure":30,"description":31,"timeFrame":12},"blood pressure","Measurement of systolic and diastolic blood pressure in millimeters of mercury (mmHg).",{"measure":33,"description":34,"timeFrame":12},"cardiometabolic risk profile","Calculation of the MetS z-score by combining waist circumference, fasting blood glucose, triglycerides, cholesterol, and blood pressure. The z-score will be reported as a single value based on these separate measures.",{"measure":36,"description":37,"timeFrame":12},"maximal oxygen uptake","Measurement of maximal oxygen uptake (VO2max) via spiroergometry.",{"measure":39,"description":40,"timeFrame":12},"liver fat status","Measurement of liver fat status via ultrasound examination.",{"measure":42,"description":43,"timeFrame":12},"composition of the intestinal and oral microbiome","Determination of the composition of the intestinal and oral microbiome by sequencing bacterial 16sRNA on the MiSeq platform, as well as analysis of the stool metabolome.",{"measure":45,"description":46,"timeFrame":12},"skin microbiome","Determination of the composition of the skin microbiome.",{"measure":48,"description":49,"timeFrame":12},"cortisol","Detection of cortisol from 24-hour urine collection.",{"measure":51,"description":52,"timeFrame":12},"body weight","Measurement of body weight in kilograms (kg) using bioimpedance analysis.",{"measure":54,"description":55,"timeFrame":12},"body fat percentage","Measurement of body fat percentage (%) using bioimpedance analysis.",{"measure":57,"description":58,"timeFrame":12},"fat-free mass","Measurement of fat-free mass (in kilograms) using bioimpedance analysis.",{"measure":60,"description":61,"timeFrame":12},"muscle mass","Measurement of muscle mass (in kilograms) using bioimpedance analysis.",{"measure":63,"description":64,"timeFrame":12},"phase angle","Measurement of phase angle (in degrees) using bioimpedance analysis.",null,{"allocation":67,"interventionModel":68,"interventionModelDescription":65,"primaryPurpose":69,"observationalModel":65,"timePerspective":65,"maskingInfo":70},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":71,"maskingDescription":65,"whoMasked":65},"NONE",[73,79,84,89,93],{"label":74,"type":75,"description":76,"interventionNames":77},"Metabolic syndrome - alternate day fasting","EXPERIMENTAL","Patients with metabolic syndrome who undergo alternate-day fasting in addition to regular advice on the mediterranean diet",[78],"Other: Alternate day fasting",{"label":80,"type":75,"description":81,"interventionNames":82},"Metabolic syndrome - time restricted eating","Patients with metabolic syndrome who undergo time restricted eating in addition to regular advice on the mediterranean diet",[83],"Other: Time restricted eating",{"label":85,"type":75,"description":86,"interventionNames":87},"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",[83,88],"Other: High-intensity interval training",{"label":90,"type":91,"description":92,"interventionNames":65},"Metabolic syndrome - controls","NO_INTERVENTION","Patients with metabolic syndrome exclusively receiving regular advice on the mediterranean diet",{"label":94,"type":91,"description":95,"interventionNames":65},"Healthy - controls","Healthy controls exclusively receiving regular advice on the mediterranean diet",[97,101,105],{"type":6,"name":98,"description":99,"armGroupLabels":100,"otherNames":65},"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.",[74],{"type":6,"name":102,"description":103,"armGroupLabels":104,"otherNames":65},"Time restricted eating","Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.",[80,85],{"type":6,"name":106,"description":107,"armGroupLabels":108,"otherNames":65},"High-intensity interval training","Patients participate in high-intensity interval training.",[85],[110],{"name":111,"role":112,"phone":113,"phoneExt":65,"email":114},"Prof. Dr. med. Yurdagül Zopf","CONTACT","0049091318545220","yurdaguel.zopf@uk-erlangen.de",[116],{"facility":117,"status":118,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":130},"Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen","RECRUITING","Erlangen","Bavaria","91054","Germany","DE",{"type":125,"coordinates":126},"Point",[127,128],11.00783,49.59099,{"lat":128,"lon":127},[131],{"name":111,"role":112,"phone":113,"phoneExt":65,"email":132},"hectorcenter.m1@uk-erlangen.de",{"type":134,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"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",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":149,"type":150},250,"ESTIMATED","INTERVENTIONAL",[153],"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.",[156,157],"Metabolic Syndrome","Obesity and Obesity-related Medical Conditions",[159,160,161,162,163],"obesity","metabolic syndrome","high-intensity interval training","inflammation","intermittent fasting","2025-03-17",{"date":166,"type":167},"2025-03-20","ACTUAL",{"date":169,"type":167},"2023-06-01",{"date":171,"type":150},"2026-03",{"name":5,"class":6},1]