Effect of Oral Supplements for Influenza Vaccine Response

ConditionInfluenza Vaccine Response

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60-70

SponsorTsinghua University

About this trial

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:

1. To explore the efficacy of fatty acid and bile acid based supplements on enhancing flu vaccine immune response. 2. To evaluate the safety of fatty acid and bile acid use in elders. 3. To explore the potential role of microbiota in regulating immune response.

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:

1. Participants will be required to intake the assigned supplement or placebo daily for 25 days; 2. Receive a influenza vaccine on day 4; 3. Provide blood samples three times and stool samples twice at base line and endpoint respectively; 4. The antibody's titer and safety indicators will be analyzed and compared among groups.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 60-70 years old

Body Mass Index (BMI) 18.5-26.9 kg/m²

No influenza vaccination in the past year

Able to understand and sign the informed consent form, and capable of completing the full follow-up process

Disqualifiers

Severe lipid metabolism disorders

Use of lipid-lowering medications, weight loss drugs, or insulin within the past three months

Vaccination with other vaccines within the past three months

Use of probiotics or prebiotics within the past three months

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine
Biological/Vaccine
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.

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: ARA (Arachidonic Acid) Supplement GroupExperimental treatment 2 interventions

Group B: TUDCA (Tauroursodeoxycholic acid) Supplement GroupExperimental treatment 2 interventions

Group C: Placebo Comparator GroupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tsinghua University

Lead sponsor

Second Affiliated Hospital of Bengbu Medical College

Collaborator

Source ClinicalTrials.gov

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