Agaricus Bisporus and Influenza Vaccination Response

NCT06041867 | Completed

• 1 other identifier: METC 23-026
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Response

Keywords

Agaricus bisporus; Immune system; Influenza vaccination; Mushroom

Outcome Measures

Primary Outcomes (1)

• Vaccine specific antibody titer

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

  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 (19)

• Immune parameters (1)

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

• Immune parameters (2)

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

• Leukocyte count

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

• Leukocyte differential count

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

• Fasted metabolism (1)

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

Study Arms (2)

Agaricus bisporus group

EXPERIMENTAL

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

Biological: Influenza vaccine; Dietary Supplement: Agaricus bisporus capsules

Placebo group

PLACEBO COMPARATOR

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

Biological: Influenza vaccine; Dietary Supplement: Control capsules

Interventions

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 group; Placebo group

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

Agaricus bisporus group

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

Placebo group

Eligibility Criteria

• Age: 59 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Scelta Mycofriends B.V.: collaborator
• CNC Grondstoffen B.V.: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: September 14, 2023
• Primary Completion: December 15, 2023
• Study Completion: May 30, 2024
• Last Updated: March 24, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)