Effect of Oral Supplements for Influenza Vaccine Response

NCT06827873 | Not Yet Recruiting

• 1 other identifier: THU01-20240201
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To explore the efficacy of fatty acid and bile acid based supplements on enhancing flu vaccine immune response.
2. 2.To evaluate the safety of fatty acid and bile acid use in elders.
3. 3.To explore the potential role of microbiota in regulating immune response.
4. 4.Participants will be required to intake the assigned supplement or placebo daily for 25 days;
5. 5.Receive a influenza vaccine on day 4;
6. 6.Provide blood samples three times and stool samples twice at base line and endpoint respectively;
7. 7.The antibody's titer and safety indicators will be analyzed and compared among groups.

Conditions

Influenza Vaccine Response

Keywords

Vaccine Efficacy; Elderly Immunity; Fatty Acid Supplementation; Gut Microbiota; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Changes in Inflammatory Markers

  Day 0 and Day 24

• Gut Microbiota Composition Changes

  Day 0 and Day 24

• Metabolomics Analysis

  Day 0, Day 13 and Day 24

Other Outcomes (3)

• Safety Assessment

  Throughout the entire study period (Day 0-Day 24)

• Dietary Intake Assessment

  Day 0 and Day 24

• Coagulation Function and Thrombosis Risk Assessment

  Day 0 and Day 24

Study Arms (3)

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.

Dietary Supplement: ARA (Arachidonic Acid) Supplementation; Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine

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.

Drug: TUDCA (Tauroursodeoxycholic Acid) Supplementation; Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine

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.

Dietary Supplement: Placebo Supplementation; Biological: Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine

Interventions

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.

Also known as: AA, 5,8,11,14-Eicosatetraenoic acid, C20:4

ARA (Arachidonic Acid) Supplement Group

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.

TUDCA (Tauroursodeoxycholic acid) Supplement Group

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.

Also known as: Placebo Capsules

Placebo Comparator Group

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.

Also known as: Quadrivalent Influenza Vaccine

ARA (Arachidonic Acid) Supplement Group; Placebo Comparator Group; TUDCA (Tauroursodeoxycholic acid) Supplement Group

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Use of steroids, immunosuppressants, or other hormonal medications within the past year
• Immunodeficiency diseases
• Severe vaccine allergy history
• Liver or kidney metabolic disorders
• Occurrence of fever, common cold, severe diarrhea, or other diseases within the past month
• Poorly controlled chronic diseases (such as blood pressure, blood sugar)
• Intake of influenza antiviral drugs within the past two weeks
• Cognitive function impairment
• Planning to undergo surgery in the near future

Sponsors & Collaborators

• Tsinghua University: lead
• Second Affiliated Hospital of Bengbu Medical College: collaborator

Study Sites (1)

Tsinghua University

Beijing, Beijing Municipality, 100084, China

Location

Related Publications (3)

• 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.

  PMID: 35928688 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.

  PMID: 39340066 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.

  PMID: 35996998 RESULT

MeSH Terms

Interventions

Arachidonic Acid; Dietary Supplements; ursodoxicoltaurine; Influenza Vaccines

Intervention Hierarchy (Ancestors)

Arachidonic Acids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Essential; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Ai Zhao, Doctor

CONTACT

+86 13811131994; aizhao18@mail.tsinghua.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study supplements are identical in appearance and packaging to maintain blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)