An interventional study of ARA (Arachidonic Acid) Supplementation and TUDCA (Tauroursodeoxycholic Acid) Supplementation in Influenza Vaccine Response, sponsored by Tsinghua University. Not yet recruiting at 1 site in China. Open to participants aged 60 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Tsinghua University · Not applicable, Interventional, and Prevention
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:
This study will conduct a randomized clinical trial to compare the efficacy of fatty acid / 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:
This 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.
Influenza virus infection presents a significant global health challenge, particularly threatening the elderly population due to immunosenescence. The immune response to influenza vaccination involves a complex series of events: after vaccination, hemagglutination inhibition antibody titers peak around day 14, accompanied by the production of neutralizing antibodies and other specific antibodies. This immune response gradually stabilizes to a post-response baseline level as immune memory establishes.
The age-related decline in immune function manifests through multiple mechanisms,including: reduced production of naive T cells; decreased diversity of T cell repertoire; compromised B cell function, altered cytokine production profiles which all diminished vaccine response efficacy.
Recent advances in immunometabolism have revealed the crucial role of specific fatty acids in immune system modulation. Our preliminary explorations found that，short-term Arachidonic Acid（AA）intervention could significantly reduce the time required for antibody production and enhance its levels following rabies vaccination. We also noticed that the serum Tauro Ursodesoxy Cholic Acid (TUDCA) was elevated in the intervention group. However, the related mechanism is still not clear.
The theoretical framework integrates nutritional immunology with classical vaccinology, focusing on the metabolic interaction between dietary fatty acids and immune cell function. This approach is particularly relevant for the elderly population, where reduced vaccine responsiveness due to immunosenescence presents a significant challenge in achieving optimal vaccine protection.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 45 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Tsinghua University is the lead sponsor of 24 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: ARA (Arachidonic Acid) Supplementation · Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine
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.
Drug: TUDCA (Tauroursodeoxycholic Acid) Supplementation · Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine
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.
Dietary Supplement: Placebo Supplementation · Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine
Oral ARA (Arachidonic Acid) dietary supplement capsules, dosage 1000 mg/person/day. 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.
Also known as: AA, 5,8,11,14-Eicosatetraenoic acid, C20:4
Oral Double Wood brand TUDCA (Tauroursodeoxycholic Acid) dietary supplement capsules, dosage 1000 mg/person/day. 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.
Oral placebo capsules identical in appearance and smell, dosage 1000 mg/person/day. 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.
Also known as: Placebo Capsules
Administer Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine, produced by Shanghai Biological Products Research Institute Co., Ltd. , specification 0.5ml/dose, 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.
Also known as: Quadrivalent Influenza Vaccine
Specific Antibody Levels and Neutralizing Antibody Responses to Influenza Vaccine
By detecting serum neutralizing and specific antibody levels on Day 13 and Day 24, evaluate the impact of different dietary supplements on influenza vaccine immune responses in elderly individuals. Focus primarily on changes in antibody titers to determine whether dietary supplementation can enhance vaccine immunogenicity.
Time frame: Day 13 and Day 24
Changes in Inflammatory Markers
Measure serum levels of inflammatory factors such as IL-1, IL-2, IL-6, IL-8, IL-10, IL-17 to assess the potential modulatory effect of dietary supplementation on inflammatory responses.
Time frame: Day 0 and Day 24
Gut Microbiota Composition Changes
Analyze intestinal microbiota structure and metabolomics changes through fecal samples to explore the impact of dietary supplementation on gut microecology, including: 1. Alpha diversity analysis (Shannon index, Chao1 index, observed species) 2. Beta diversity analysis (UniFrac distance, Bray-Curtis dissimilarity) 3. Microbial species composition and relative abundance changes 4. Key microbiota (such as Bacteroidetes, Actinobacteria) abundance analysis 5. Metabolic pathway changes, including KEGG functional pathway prediction and microbiota-related immune metabolic pathways
Time frame: Day 0 and Day 24
Metabolomics Analysis
Perform non-targeted metabolomics detection to evaluate the impact of dietary supplementation on human metabolic levels, including lipid profiles, liver and kidney function indicators.
Time frame: Day 0, Day 13 and Day 24
Safety Assessment
Record and analyze adverse reactions during the intervention, including clinical symptoms, blood routine, and biochemical indicators to assess the safety of dietary supplements.
Time frame: Throughout the entire study period (Day 0-Day 24)
Dietary Intake Assessment
Record dietary intake patterns of study subjects through 24-hour dietary recall and FFQ surveys to control nutritional factors that might influence results.
Time frame: Day 0 and Day 24
Coagulation Function and Thrombosis Risk Assessment
Assess the impact of dietary supplements on blood coagulation function by detecting coagulation time and related coagulation indicators, and exclude the risks of coagulation disorders and thrombosis. Focus on changes in coagulation time, platelet count, and coagulation factors.
Time frame: Day 0 and Day 24
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Plan to share: No
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Tsinghua University