Agaricus Bisporus and Influenza Vaccination Response

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Immune Response

Treatments: Dietary Supplement: Control capsules; Biological: Influenza vaccine; Dietary Supplement: Agaricus bisporus capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT06041867

METC 23-026

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 59+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups, including a placebo group

Agaricus bisporus group

Experimental group

Description:

Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each

Treatment:

Dietary Supplement: Agaricus bisporus capsules

Biological: Influenza vaccine

Placebo group

Placebo Comparator group

Description:

Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder

Treatment:

Dietary Supplement: Control capsules

Biological: Influenza vaccine