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| Name | Class |
|---|---|
| Second Affiliated Hospital of Bengbu Medical College | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| TUDCA (Tauroursodeoxycholic acid) Supplement Group | Experimental | 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARA (Arachidonic Acid) Supplementation | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 13 and Day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 and Day 24 |
| Gut Microbiota Composition Changes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout the entire study period (Day 0-Day 24) |
| Dietary Intake Assessment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ai Zhao, Doctor | Contact | +86 13811131994 | aizhao18@mail.tsinghua.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tsinghua University | Beijing | Beijing Municipality | 100084 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35928688 | Result | Sainz T, Casas I, Gonzalez-Esguevillas M, Escosa-Garcia L, Munoz-Fernandez MA, Prieto L, Gosalbes MJ, Jimenez-Hernandez N, Ramos JT, Navarro ML, Mellado MJ, Serrano-Villar S, Calvo C. Nutritional Supplementation to Increase Influenza Vaccine Response in Children Living With HIV: A Pilot Clinical Trial. Front Pediatr. 2022 Jul 19;10:919753. doi: 10.3389/fped.2022.919753. eCollection 2022. | |
| 39340066 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 10, 2025 | Feb 10, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016718 | Arachidonic Acid |
| D019587 | Dietary Supplements |
| C031655 | ursodoxicoltaurine |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D001095 | Arachidonic Acids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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Forty-five adults aged 60-70 years are randomly assigned in equal numbers (n=15 per group) to three parallel groups: two intervention groups receiving different supplements(arachidonic acid and TUDCA) and one control group receiving placebo. The intervention period lasts 25 days, from Day 0 to Day 24. Triple-blinding is implemented to ensure that both participants and investigators are unaware of group assignments.
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All study supplements are identical in appearance and packaging to maintain blinding.
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| TUDCA (Tauroursodeoxycholic Acid) Supplementation | Drug | 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. |
|
| Placebo Supplementation | Dietary Supplement | 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. |
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| Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine | Biological | 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. |
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Analyze intestinal microbiota structure and metabolomics changes through fecal samples to explore the impact of dietary supplementation on gut microecology, including:
|
| 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. | Day 0, Day 13 and Day 24 |
Record dietary intake patterns of study subjects through 24-hour dietary recall and FFQ surveys to control nutritional factors that might influence results. |
| 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. | Day 0 and Day 24 |
| Result |
| D'Onofrio V, Porrez S, Jacobs B, Alhatemi A, De Boever F, Waerlop G, Michels E, Vanni F, Manenti A, Leroux-Roels G, Platenburg PP, Hilgers L, Leroux-Roels I. Safety and Immunogenicity of a Carbohydrate Fatty Acid Monosulphate Ester Adjuvant Combined with a Low-Dose Quadrivalent Split-Virion Inactivated Influenza Vaccine: A Randomised, Observer-Blind, Active-Controlled, First-in-Human, Phase 1 Study. Vaccines (Basel). 2024 Sep 10;12(9):1036. doi: 10.3390/vaccines12091036. |
| 35996998 | Result | Chou CH, Mohanty S, Kang HA, Kong L, Avila-Pacheco J, Joshi SR, Ueda I, Devine L, Raddassi K, Pierce K, Jeanfavre S, Bullock K, Meng H, Clish C, Santori FR, Shaw AC, Xavier RJ. Metabolomic and transcriptomic signatures of influenza vaccine response in healthy young and older adults. Aging Cell. 2022 Sep;21(9):e13682. doi: 10.1111/acel.13682. Epub 2022 Aug 23. |
| D008055 |
| Lipids |
| D005228 | Fatty Acids, Essential |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |