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Completed

NCT Number: NCT06041867

Agaricus Bisporus and Influenza Vaccination Response

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.

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Key information

Conditions

Immune Response Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

59 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

influenza vaccine

Biological

Single dose of the Influenza vaccine Participants have to wait until they are invited to receive the vaccine by the general practitioner; this study does not interfere with national planning of the vaccine

Agaricus bisporus capsules

Dietary Supplement

Participants have to consume 10 capsules per day containing 500 mg Agaricus bisporus powder each, corresponding to a total Agariicus bisporus powder intake of 5 g daily

Control Capsules

Dietary Supplement

Participants have to consume 10 capsules per day containing 500 mg maltodextrin each, corresponding to a total maltodextrin intake of 5 g daily

Primary outcomes

  1. Vaccine specific antibody titer

    Time frame: 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))

    The response to the Influenza vaccine will be measured by quantifying the specific antibody titer

Secondary outcomes

  1. Immune parameters (1)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system

  2. Immune parameters (2)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    hsCRP

  3. Leukocyte count

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    Number of leukocytes measured in EDTA plasma

  4. Leukocyte differential count

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    Number of subgroups of leukocytes measured in EDTA plasma

  5. Fasted metabolism (1)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    Serum non-cholesterol sterols and stanols

  6. Fasted metabolism (2)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    Serum lipid and lipoprotein profile

  7. Fasted metabolism (3)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    Plasma glucose

  8. Fasted metabolism (4)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    Ergothioneine

  9. Fasted metabolism (5)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    Glutathione

  10. Fasted metabolism (6)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)

    Malondialdehyde

  11. Anthropometry (1)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

    Body weight

  12. Anthropometry (2)

    Time frame: Day -1 (start study)

    Height

  13. Anthropometry (3)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

    Waist circumference

  14. Anthropometry (4)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

    Hip circumference

  15. Anthropometry (5)

    Time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)

    Waist-to-hip ratio

  16. Diet

    Time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)

    Food frequency questionnaire is used to determine if the participants maintain their habitual diet and to determine if the participants do not consume mushrooms outside the intervention

  17. Quality of life questionnaire

    Time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)

    Quality of life questionnaire is used to determine the participants overall wellbeing and quality of life

  18. Diary outcomes (1)

    Time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)

    Adverse events as assessed by the diary

  19. Diary outcomes (2)

    Time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)

    Medication intake as assessed by the diary

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • CNC Grondstoffen B.V.
  • Scelta Mycofriends B.V.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 18, 2023
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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