Clinical trial NCT06041867: Agaricus Bisporus and Influenza Vaccination Response
Official title: Mushboost: Evaluating the Effect of Agaricus Bisporus Powder Intake on the Vaccination Response to an Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Response
Keywords: Agaricus bisporus
Immune system
Influenza vaccination
Mushroom
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Scelta Mycofriends B.V.
name: CNC Grondstoffen B.V.
First posted: 2023-09-18
Enrollment: 88
Sex: ALL
Minimum age (years): 59
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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)

Primary outcomes:
measure: Vaccine specific antibody titer
timeFrame: Time Frame: Differences in influenza specific antibody titers at any measured time point ((Day=0 (day before vaccination), weekly in the month after vaccination (week 1, week 2, week 3 and week 4 after vaccination))
Secondary outcomes:
measure: Immune parameters (1)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Immune parameters (2)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Leukocyte count
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Leukocyte differential count
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Fasted metabolism (1)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Fasted metabolism (2)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Fasted metabolism (3)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Fasted metabolism (4)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Fasted metabolism (5)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Fasted metabolism (6)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
measure: Anthropometry (1)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (2)
timeFrame: Day -1 (start study)
measure: Anthropometry (3)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (4)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Anthropometry (5)
timeFrame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
measure: Diet
timeFrame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
measure: Quality of life questionnaire
timeFrame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
measure: Diary outcomes (1)
timeFrame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
measure: Diary outcomes (2)
timeFrame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References: