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Evaluating the effect of Agaricus bisporus powder intake on the vaccination response to an influenza vaccine

Evaluating the effect of Agaricus bisporus powder intake on the vaccination response to an influenza vaccine - Agaricus bisporus and influenza vaccination response

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53177
Enrollment
105
Registered
2023-08-01
Start date
2023-09-14
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

verminderde immuunrespons Decreased immune response

Interventions

The intervention group will receive 10 capsules daily containing Agaricus bisporus powder to reach a required dose of 5.0 gr Agaricus bisporus powder per day. The control group will receive placebo

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the vaccination response to an influenza vaccine.

Secondary

MeasureTime frame
Secondary endpoints include amongst others, hematological, inflammatory and immunological parameters (e.g. hs-CRP, leukocyte differential count, cytokines) and metabolic markers (e.g. blood lipid profiles, plasma glucose).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)