[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620426":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":30,"responsibleParty":46,"collaborators":50,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":83,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Tsinghua University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"TUDCA Supplementation Group",null,"Participants who received TUDCA supplementation (1000 mg\u002Fday) during the original study (February-April 2025). In the original trial, participants took 1000 mg of TUDCA (Tauroursodeoxycholic acid) dietary supplement capsules daily. Each capsule contained 500 mg of TUDCA (two capsules per serving). Participants maintained their usual lifestyle during the intervention: Day 0-Day 2 served as an adaptation period; on Day 3, they received a quadrivalent influenza vaccine, followed by continued supplementation until Day 24. This extended follow-up study involves no intervention, only a single fasting blood draw (20 mL) approximately 12 months post-vaccination to assess long-term immune responses.",{"label":13,"type":10,"description":14,"interventionNames":10},"Placebo Group","Participants who received placebo during the original study (February-April 2025). In the original trial, participants took placebo capsules identical in appearance and smell to the TUDCA capsules. Participants maintained their usual lifestyle during the intervention: Day 0-Day 2 served as an adaptation period; on Day 3, they received a quadrivalent influenza vaccine, followed by continued placebo supplementation until Day 24. This extended follow-up study involves no intervention, only a single fasting venous blood draw (approximately 20 mL) about 12 months post-vaccination to assess long-term immune responses.",[16],{"name":17,"affiliation":18,"role":19},"Cong Tian, Master","Second Affiliated Hospital of Bengbu Medical College","STUDY_DIRECTOR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Ai Zhao, PhD","CONTACT","+86 13811131994","aizhao18@mail.tsinghua.edu.cn",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Litian Hou, Master","+86 17888846812","hlt24@mails.tsinghua.edu.cn",[31],{"facility":5,"status":10,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Beijing","Beijing Municipality","100084","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},[44,45],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Ai Zhao","Associate Professor",[51],{"name":18,"class":6},"100620426","effect-of-oral-supplement-on-influenza-vaccine-long-term-response-100620426",false,"NCT07357467","Effect of Oral Supplement on Influenza Vaccine Long-term Response","Effect of Oral Supplement Intervention on Influenza Vaccine Long-term Efficacy: a Follow-up Study","EOSIIVE-F","Inclusion Criteria:\n\n1. Originally assigned to either the TUDCA supplementation group or placebo control group\n2. No influenza vaccination or other vaccines received between April 2025 and December 2025\n3. Willing to participate in this follow-up study and sign supplementary informed consent\n4. Stable health condition\n\nExclusion Criteria:\n\n1. Started using immunosuppressants or hormonal medications after the original study\n2. Experienced serious illness or hospitalization within the past month, or planning surgery soon\n3. Experienced fever, cold, severe diarrhea, or taken influenza antiviral medications within the past month\n4. Unable or unwilling to participate in blood collection\n5. Lost to follow-up or unable to contact",true,"ALL","60 Years","70 Years",{"count":65,"type":66},30,"ESTIMATED","1 Year","OBSERVATIONAL","This is a follow-up study of a previously completed randomized controlled trial (NCT06827873) that investigated the effects of oral supplements on influenza vaccine response in adults aged 60-70 years. The original study was completed in April 2025, with participants receiving either TUDCA (Tauro Ursodesoxy Cholic Acid) supplementation, fatty acid supplementation, or placebo during influenza vaccination.\n\nThe primary objectives of this follow-up study are to:\n\n1. Evaluate the durability of vaccine-induced antibody responses approximately 8 months post-vaccination\n2. Assess the persistence of immune memory cells, particularly long-lived plasma cells and memory B cells\n3. Compare long-term immune responses between the TUDCA supplementation group and placebo group\n\nThis observational follow-up involves a single visit where participants will:\n\n1. Provide one blood sample for antibody and immune cell analysis\n2. No intervention or vaccination will be administered\n\nThe study will specifically focus on B cell subsets through flow cytometry analysis, including total B cells, memory B cells, plasma cells, and long-lived plasma cells. This research aims to determine whether TUDCA supplementation can enhance the durability of vaccine-induced immunity in older adults.",[71,72],"Influenza","Immunosenescence",[74,75,76,77,78,79,80,81,82],"Tauroursodeoxycholic Acid (TUDCA)","Influenza Vaccine","Antibody","Memory B Cells","Long-lived Plasma Cells","Elderly Adults","Humoral Immunity","Nutritional Immunomodulation","Bile Acids","NOT_YET_RECRUITING","2026-01-20",{"date":86,"type":87},"2026-01-22","ACTUAL",{"date":89,"type":66},"2026-03",{"date":91,"type":66},"2026-07",{"name":5,"class":6},1]