[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579713":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":41,"centralContacts":55,"locations":61,"responsibleParty":80,"collaborators":84,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":41,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":114,"whyStopped":41,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Tsinghua University","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"ARA (Arachidonic Acid) Supplement Group","EXPERIMENTAL","Participants will take 1000 mg of ARA (Arachidonic Acid) dietary supplement capsules daily. Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue supplementation until Day 24.",[13,14],"Dietary Supplement: ARA (Arachidonic Acid) Supplementation","Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine",{"label":16,"type":10,"description":17,"interventionNames":18},"TUDCA (Tauroursodeoxycholic acid) Supplement Group","Participants will take 1000 mg of TUDCA (Tauroursodeoxycholic acid) dietary supplement capsules daily. Capsules primarily contain TUDCA, with 500 mg per serving (two capsules). Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue supplementation until Day 24.",[19,14],"Drug: TUDCA (Tauroursodeoxycholic Acid) Supplementation",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo Comparator Group","PLACEBO_COMPARATOR","Participants will take 1000 mg of placebo capsules identical in appearance and smell. Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue taking placebo until Day 24.",[25,14],"Dietary Supplement: Placebo Supplementation",[27,36,42,48],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","ARA (Arachidonic Acid) Supplementation","Oral ARA (Arachidonic Acid) dietary supplement capsules, dosage 1000 mg\u002Fperson\u002Fday. Capsule composition includes: C14:0 (0.15%), C16:0 (6.08%), C16:1 (0.15%), C18:0 (4.57%), C18:1 (19.65%), C18:2 (38.46%), C18:3 (0.87%), C20:0 (0.50%), C20:3 (2.00%), C20:4 (18.66%), C22:0 (1.81%), C24:0 (4.05%). Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue supplementation until Day 24.",[9],[33,34,35],"AA","5,8,11,14-Eicosatetraenoic acid","C20:4",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","TUDCA (Tauroursodeoxycholic Acid) Supplementation","Oral Double Wood brand TUDCA (Tauroursodeoxycholic Acid) dietary supplement capsules, dosage 1000 mg\u002Fperson\u002Fday. Capsules primarily contain TUDCA, with 500 mg per serving (two capsules), other ingredients include gelatin and rice powder. Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue supplementation until Day 24.",[16],null,{"type":28,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Placebo Supplementation","Oral placebo capsules identical in appearance and smell, dosage 1000 mg\u002Fperson\u002Fday. Placebo capsule composition includes: C14:0 (0.09%), C16:0 (6.12%), C16:1 (0.03%), C18:0 (3.50%), C18:1 (28.06%), C18:2 (59.40%), C20:0 (0.27%), C22:0 (0.76%), C24:0 (0.26%). Maintain original lifestyle during intervention, Day 0-Day 2 as adaptation period, receive quadrivalent influenza vaccine on Day 3, continue taking placebo until Day 24.",[21],[47],"Placebo Capsules",{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"BIOLOGICAL","Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine","Administer Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine, produced by Shanghai Biological Products Research Institute Co., Ltd. , specification 0.5ml\u002Fdose, containing 15.0 μg hemagglutinin (for each influenza virus strain), suitable for intramuscular injection in individuals 6 months and older. Administer one dose to all study participants on Day 3. Closely observe and record any potential adverse reactions after vaccination.",[9,21,16],[54],"Quadrivalent Influenza Vaccine",[56],{"name":57,"role":58,"phone":59,"phoneExt":41,"email":60},"Ai Zhao, Doctor","CONTACT","+86 13811131994","aizhao18@mail.tsinghua.edu.cn",[62],{"facility":5,"status":41,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Beijing","Beijing Municipality","100084","China","CN",{"type":69,"coordinates":70},"Point",[71,72],116.39723,39.9075,{"lat":72,"lon":71},[75,76],{"name":57,"role":58,"phone":59,"phoneExt":41,"email":60},{"name":77,"role":58,"phone":78,"phoneExt":41,"email":79},"Litian Hou, Master","+86 17888846812","hlt24@mails.tsinghua.edu.cn",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Ai Zhao","Associate Professor",[85],{"name":86,"class":6},"Second Affiliated Hospital of Bengbu Medical College","100579713","effect-of-oral-supplements-for-influenza-vaccine-response-100579713",false,"NCT06827873","Effect of Oral Supplements for Influenza Vaccine Response","Effect of Oral Supplement Intervention on Influenza Vaccine Efficacy: a Randomized Controlled Clinical Trial","EOSIIVE-RCT","Inclusion Criteria:\n\n1. Age 60-70 years old\n2. Body Mass Index (BMI) 18.5-26.9 kg\u002Fm²\n3. No influenza vaccination in the past year\n4. Able to understand and sign the informed consent form, and capable of completing the full follow-up process\n\nExclusion Criteria:\n\n1. Severe lipid metabolism disorders\n2. Use of lipid-lowering medications, weight loss drugs, or insulin within the past three months\n3. Vaccination with other vaccines within the past three months\n4. Use of probiotics or prebiotics within the past three months\n5. Use of steroids, immunosuppressants, or other hormonal medications within the past year\n6. Immunodeficiency diseases\n7. Severe vaccine allergy history\n8. Liver or kidney metabolic disorders\n9. Occurrence of fever, common cold, severe diarrhea, or other diseases within the past month\n10. Poorly controlled chronic diseases (such as blood pressure, blood sugar)\n11. Intake of influenza antiviral drugs within the past two weeks\n12. Cognitive function impairment\n13. Planning to undergo surgery in the near future",true,"ALL","60 Years","70 Years",{"count":100,"type":101},45,"ESTIMATED","INTERVENTIONAL",[104],"NA","The aim of this clinical trial is to explore the efficacy of fatty acid and bile acid based supplements on enhancing influenza vaccine immune response in adults aged 60-70 years. The objectives of this study are:\n\n1. To explore the efficacy of fatty acid and bile acid based supplements on enhancing flu vaccine immune response.\n2. To evaluate the safety of fatty acid and bile acid use in elders.\n3. To explore the potential role of microbiota in regulating immune response.\n\nThis study will conduct a randomized clinical trial to compare the efficacy of fatty acid \u002F bile acid (Tauro Ursodesoxy Cholic Acid, TUDCA)supplements on enhancing vaccine immune response. The antibody's titer and safety indicators after influenza vaccination will be evaluated. Study process are:\n\n1. Participants will be required to intake the assigned supplement or placebo daily for 25 days;\n2. Receive a influenza vaccine on day 4;\n3. Provide blood samples three times and stool samples twice at base line and endpoint respectively;\n4. The antibody's titer and safety indicators will be analyzed and compared among groups.\n\nThis study aims to establish a theoretical foundation for utilizing nutritional strategies to enhance vaccine-induced immune responses and to provide a scientific framework for developing oral vaccine boosters.",[107],"Influenza Vaccine Response",[109,110,111,112,113],"Vaccine Efficacy","Elderly Immunity","Fatty Acid Supplementation","Gut Microbiota","Randomized Controlled Trial","NOT_YET_RECRUITING","2025-02-10",{"date":117,"type":118},"2025-02-14","ACTUAL",{"date":120,"type":101},"2025-02",{"date":122,"type":101},"2025-10",{"name":5,"class":6},1]