Effect of Oral Supplements for Influenza 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

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

Treatments tested in this trial

  • ARA (Arachidonic Acid) Supplementation
  • TUDCA (Tauroursodeoxycholic Acid) Supplementation
  • Placebo Supplementation
  • Shanghai Biological Quadrivalent Influenza Virus Inactivated Vaccine

Treatment groups

45 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Tsinghua University

Lead sponsor

Second Affiliated Hospital of Bengbu Medical College

Collaborator