Immune ResponseNCT06041867

Agaricus Bisporus and Influenza Vaccination Response

A study testing Influenza vaccine and Agaricus bisporus capsules in people with Immune Response, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 59 years and olderHealthy volunteers can take part
Conditions the study is for: Immune Response
What is being tested?: Influenza vaccine and Agaricus bisporus capsules
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 1 siteNetherlands
Study dates: 14 Sep 2023to 30 May 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 59 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Maastricht University Medical Center
Maastricht, Limburg, 6229 ER

Other trials in Netherlands

About this study

Official title: 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.

Conditions: Immune Response
Being tested: Influenza vaccine, Agaricus bisporus capsules, Control capsules
Keywords: Agaricus bisporus, Immune system, Influenza vaccination, Mushroom
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06041867
Study group	Role	What they receive
Agaricus bisporus group	Experimental	Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each Receives: 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 Receives: Biological: Influenza vaccine; Dietary Supplement: Control capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

Vaccine specific antibody titer
The response to the Influenza vaccine will be measured by quantifying the specific antibody titer
Measured: 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)
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Immune parameters (2)
hsCRP
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Leukocyte count
Number of leukocytes measured in EDTA plasma
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Leukocyte differential count
Number of subgroups of leukocytes measured in EDTA plasma
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (1)
Serum non-cholesterol sterols and stanols
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (2)
Serum lipid and lipoprotein profile
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (3)
Plasma glucose
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (4)
Ergothioneine
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (5)
Glutathione
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (6)
Malondialdehyde
Measured: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Anthropometry (1)
Body weight
Measured: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (2)
Height
Measured: Day -1 (start study)
Anthropometry (3)
Waist circumference
Measured: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (4)
Hip circumference
Measured: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (5)
Waist-to-hip ratio
Measured: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Diet
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
Measured: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Quality of life questionnaire
Quality of life questionnaire is used to determine the participants overall wellbeing and quality of life
Measured: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Diary outcomes (1)
Adverse events as assessed by the diary
Measured: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Diary outcomes (2)
Medication intake as assessed by the diary
Measured: Day - 1 (start study), T=4 weeks after vaccination (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 202330 May 2024

First posted18 Sep 2023
Study start14 Sep 2023
Primary completion15 Dec 2023
Study completion30 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Immune ResponseStudies of the same condition, open and under way.
More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06041867
Sponsor's protocol ID: METC 23-026
Status last verified: Feb 2024
First submitted: 11 Sep 2023
Last updated: 24 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Immune Response trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mushboost: Evaluating the Effect of Agaricus Bisporus Powder Intake on the Vaccination Response to an Influenza Vaccine
ClinicalTrials.gov ID: NCT06041867
Acronym / sponsor ID: METC 23-026
Conditions: Immune Response
Keywords: Agaricus bisporus, Immune system, Influenza vaccination, Mushroom
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Maastricht University Medical CenterUniversity, hospital or other
Collaborators: Scelta Mycofriends B.V., CNC Grondstoffen B.V.
Study start: 14 Sep 2023 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 30 May 2024 (actual)
First posted: 18 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Agaricus bisporus group	Experimental	Biological: Influenza vaccine, Dietary Supplement: Agaricus bisporus capsulesDietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each
Placebo group	Placebo comparator	Biological: Influenza vaccine, Dietary Supplement: Control capsulesDietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder

Who may qualify

Ages: 59 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Influenza vaccineSingle 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	Biological	Agaricus bisporus group, Placebo group
Agaricus bisporus capsulesParticipants 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	Dietary supplement	Agaricus bisporus group
Control capsulesParticipants have to consume 10 capsules per day containing 500 mg maltodextrin each, corresponding to a total maltodextrin intake of 5 g daily	Dietary supplement	Placebo group

Primary outcome

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

19 secondary outcomes

Immune parameters (1)
Time frame: 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)
Leukocyte count
Time frame: 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)
Fasted metabolism (1)
Time frame: 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)
Fasted metabolism (3)
Time frame: Day - 1 (start study), T=0 (day before vaccination), 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)
Fasted metabolism (5)
Time frame: 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)
Anthropometry (1)
Time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (2)
Time frame: Day -1 (start study)
Anthropometry (3)
Time frame: 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)
Anthropometry (5)
Time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Diet
Time frame: 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)
Diary outcomes (1)
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Immune Response

RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Influenza vaccine and Agaricus bisporus capsules in people with Immune Response, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06041867.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.