[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592997":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":58,"id":70,"slug":12,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":12,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":41,"whyStopped":12,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control (no intervention)","NO_INTERVENTION","Four weeks of ad libitum eating pattern with eating time window \\>11 h\u002Fday. No change of the regular eating pattern.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"TRE","EXPERIMENTAL","Four weeks of TRE, where the daily eating pattern is reduced to 8 h\u002Fday. The first meal will be before 10:00 AM.",[18],"Behavioral: TRE: Time-restricted eating",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","TRE: Time-restricted eating","The daily eating pattern is reduced to 8 h\u002Fday. The first meal will be before 10:00 AM.",[14],[26,30],{"name":27,"affiliation":28,"role":29},"Sebastian Hofer, Dr. rer. nat.","Clinical Research Unit, Experimental and Clinical Research Center, Charité, Berlin, Germany & Max-Delbrück Center for Molecular Medicine, Berlin, Germany","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Anna Katharina Simon, Prof. Dr.","Max-Delbrück Center for Molecular Medicine, Berlin, Germany",[34],{"name":27,"role":35,"phone":36,"phoneExt":12,"email":37},"CONTACT","+493094062372","sebastian.hofer@charite.de",[39],{"facility":40,"status":41,"city":42,"state":12,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Clinical Research Unit, Experimental & Clinical Research Center, Campus Buch, Charité","RECRUITING","Berlin","13125","Germany",{"type":46,"coordinates":47},"Point",[48,49],13.41053,52.52437,{"lat":49,"lon":48},[52],{"name":53,"role":35,"phone":54,"phoneExt":12,"email":55},"Sylvia Bähring, PD Dr.","+4930450540214","ecrc-cru@charite.de",{"type":29,"investigatorFullName":27,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Dr. rer. nat.",[59,62,64,66,68],{"name":60,"class":61},"Max Delbrück Center for Molecular Medicine (MDC), Berlin","UNKNOWN",{"name":63,"class":61},"Labor Berlin, Germany",{"name":65,"class":61},"Experimental & Clinical Research Center Berlin",{"name":67,"class":6},"University of Oxford",{"name":69,"class":6},"University of Cologne","100592997",false,"NCT07000708","VITAL: Vaccination, Immunity, Time-restricted Eating, Aging and Lifestyle","VITAL","Inclusion Criteria:\n\n* Male and female participants, enrolled in a 1:1 ratio\n* Age 60-85 years\n* Body mass index (BMI) 20-35 kg\u002Fm²\n* Capacity to give informed consent\n* Existing health insurance to allow evaluation and treatment of any incidental findings\n* Usual daily eating window \\> 11 hours\n* First meal of the day before 10:00 AM\n* Willingness to receive seasonal influenza and COVID-19 vaccination and proof of scheduled appointment\n* Willingness and ability to follow a prescribed TRE dietary regimen (8-hour daily eating window; 16-hour fast without any caloric intake)\n* Appointment for simultaneous influenza and COVID-19 vaccination pre-arranged with primary care physician and coordinated with study team to align with TRE intervention\n\nExclusion Criteria:\n\n* Any vaccination (especially influenza and\u002For COVID-19) within 6 months before the intervention start\n* Vaccinations not related to the study, administered during the study period from V0 to V4\n* History of influenza infection within 6 months prior to initiation of the study intervention\n* History of severe adverse reactions to prior vaccinations\n* Use of pharmacological weight-loss agents (e.g., semaglutide)\n* Diabetes mellitus under ongoing pharmacological treatment\n* Symptoms of systemic inflammatory or autoimmune disease\n* Immunosuppression (including use of immunosuppressive drugs)\n* Severe hypertension (systolic \\> 180 mmHg or diastolic \\> 110 mmHg)\n* Diseases or functional disorders which, in the opinion of the study physician, preclude participation in the study\n* Participation in any fasting intervention (e.g., TRE, alternate-day fasting, 5:2, 18:6) within 6 months before enrollment\n* Participation in another diet or weight-loss program (e.g., intensive athletic training)\n* Night-shift or rotating-shift work\n* Severe, active, or unstable medical conditions requiring treatment\n* Postoperative recovery phase\n* Antibiotic therapy within 3 months before enrollment\n* Acute or chronic infections\n* Therapeutic or medically prescribed special diets\n* Vegan diet\n* Current smoker\n* Weight change \\> 2 kg in the month before enrollment\n* Known substance, drug, or alcohol abuse\n* Anemia\n* Claustrophobia\n* Legal incapacity or any other circumstance that prevents full understanding of the nature, importance, and implications of the study",true,"ALL","60 Years","85 Years",{"count":81,"type":82},24,"ESTIMATED","INTERVENTIONAL",[85],"NA","The aim of this study is to investigate the effects of a four-week time-restricted eating (TRE) intervention on autophagy, immune function, and vaccine response to a seasonal influenza and COVID-19 vaccines in older healthy subjects.",[88,89,90],"Vaccination","Immunosenescence","Metabolism",[92,93,94,95,96,97,98,99],"fasting","vaccination","intermittent fasting","time-restricted eating","influenza","immunity","aging","immunosenescence","2025-09-17",{"date":102,"type":103},"2025-09-18","ACTUAL",{"date":105,"type":103},"2025-09-10",{"date":107,"type":82},"2027-01",{"name":5,"class":6},1]