Agaricus Bisporus and Influenza Vaccination Response

Last updated: March 20, 2025
Sponsor: Maastricht University Medical Center
Overall Status: Completed

Phase

N/A

Condition

Allergy

Treatment

Influenza vaccine

Control capsules

Agaricus bisporus capsules

Clinical Study ID

NCT06041867
METC 23-026
  • Ages > 59
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

There are numerous in vitro and animal studies that suggested that mushrooms beneficially influence the immune system. We have recently shown that a wild isolate of the edible Agaricus bisporus mushroom had a clear effect on parameters reflecting a better function of the immune system, both in vitro and in vivo in animals. The question now is whether this efficacy can also be translated to humans. In humans, measuring the antibody response is the golden standard to evaluate immune function. If Agaricus bisporus powder indeed has beneficial effects on the immune system, people with overweight or obesity and higher age might benefit from consuming Agaricus bisporus powder prior to receiving the influenza vaccination.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 60 years or older during influenza season 2023/2024 (in line with RIVMguidelines)

  • BMI between 20 and 35 kg/m2

  • Willing to abstain from mushrooms other than the capsules containing a mushroompowder as provided by us during the study period.

  • Willing to keep the intake of fish oil, Zinc, Selenium and (vitamin) supplementsconstant

  • Willing to abstain from products / supplements enriched with Vitamin D

  • Willing to abstain from products / supplements enriched with plant sterols orstanols

  • Willing to abstain from products / supplements enriched with (β)glucans or fungi.

  • Willing to abstain from products / supplements that are mentioned to "boost yourimmune system"

  • Willing to abstain from (products enriched in) pre/pro-biotics

  • Willing to abstain from products/supplements enriched with ergothioneine

Exclusion

Exclusion Criteria:

  • Already received influenza vaccination in 2023

  • Allergy to mushrooms

  • Known allergic reaction to an active component or other components of the vaccine (e.g. Chicken Eggs)

  • Having donated blood within one month prior to the start of the study, or planningto donate blood during the study

  • Excessive alcohol use (>20 consumptions per week)

  • Regular use of soft and/or hard drugs

  • Using medication for diseases known to affect inflammation/immunity (e.g. inhaledcorticosteroids and prednisone)

Study Design

Total Participants: 88
Treatment Group(s): 3
Primary Treatment: Influenza vaccine
Phase:
Study Start date:
September 14, 2023
Estimated Completion Date:
May 30, 2024

Connect with a study center

  • Maastricht University Medical Center

    Maastricht, Limburg 6229 ER
    Netherlands

    Site Not Available

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