Mushboost: Evaluating the Effect of Agaricus Bisporus Powder Intake on the Vaccination Response to an Influenza Vaccine

METC 23-026

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.

2023-09-14

2024-03-22

2024-05-30

Recruiting

105

Inclusion Criteria: * Aged 60 years or older during influenza season 2023/2024 (in line with RIVM guidelines) * BMI between 20 and 35 kg/m2 * Willing to abstain from mushrooms other than the capsules containing a mushroom powder as provided by us during the study period. * Willing to keep the intake of fish oil, Zinc, Selenium and (vitamin) supplements constant * Willing to abstain from products / supplements enriched with Vitamin D * Willing to abstain from products / supplements enriched with plant sterols or stanols * Willing to abstain from products / supplements enriched with (β)glucans or fungi. * Willing to abstain from products / supplements that are mentioned to "boost your immune system" * Willing to abstain from (products enriched in) pre/pro-biotics * Willing to abstain from products/supplements enriched with ergothioneine 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 planning to 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. inhaled corticosteroids and prednisone)

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 105, 'type': 'ESTIMATED'}}

2024-03-01