Agaricus Bisporus and Influenza Vaccination Response

March 20, 2025 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 ER
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Agaricus bisporus group
Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each
Biological: Influenza vaccine
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
Dietary supplement: Agaricus bisporus capsules
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
Placebo Comparator: Placebo group
Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder
Biological: Influenza vaccine
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
Dietary supplement: Control capsules
Participants have to consume 10 capsules per day containing 500 mg maltodextrin each, corresponding to a total maltodextrin intake of 5 g daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Immune parameters (2)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
hsCRP
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
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
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
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
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
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
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
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
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (3)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Plasma glucose
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Anthropometry (1)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Body weight
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (3)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Waist circumference
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (4)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Hip circumference
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
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
Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Diary outcomes (1)
Time Frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Adverse events as assessed by the diary
Day - 1 (start study), T=4 weeks after vaccination (end of study)
Diary outcomes (2)
Time Frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Medication intake as assessed by the diary
Day - 1 (start study), T=4 weeks after vaccination (end of study)
Fasted metabolism (4)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Ergothioneine
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (5)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Glutathione
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (6)
Time Frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Malondialdehyde
Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Anthropometry (2)
Time Frame: Day -1 (start study)
Height
Day -1 (start study)
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
Day - 1 (start study), T=4 weeks after vaccination (end of study)
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
Day - 1 (start study), T=4 weeks after vaccination (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Scelta Mycofriends B.V.
CNC Grondstoffen B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • METC 23-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings