Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT06041867
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
59 Years
Study:
NCT06041867
Study Brief:
Protocol Section:
NCT06041867