Agaricus Bisporus and Influenza Vaccination Response

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: Recruiting
• Conditions: Immune Response
• Intervention / Treatment: Biological: Influenza vaccine; Dietary supplement: Agaricus bisporus capsules; Dietary supplement: Control capsules

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 ER
      • Recruiting
      • Maastricht University Medical Center
      • Principal Investigator: Jogchum Plat, PhD
      • Contact: Willem Zwaan, MSc; Phone Number: +31 88 388 7283; Email: w.zwaan@maastrichtuniversity.nl

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune parameters (1)	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)	hsCRP	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	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	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	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	Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (3)	Plasma glucose	Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Anthropometry (1)	Body weight	Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (3)	Waist circumference	Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (4)	Hip circumference	Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (5)	Waist-to-hip ratio	Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Diary outcomes (1)	Adverse events as assessed by the diary	Day - 1 (start study), T=4 weeks after vaccination (end of study)
Diary outcomes (2)	Medication intake as assessed by the diary	Day - 1 (start study), T=4 weeks after vaccination (end of study)
Fasted metabolism (4)	Ergothioneine	Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (5)	Glutathione	Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (6)	Malondialdehyde	Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Anthropometry (2)	Height	Day -1 (start study)
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	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	Day - 1 (start study), T=4 weeks after vaccination (end of study)

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Scelta Mycofriends B.V.; CNC Grondstoffen B.V.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): March 22, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Immune system; Influenza vaccination; Mushroom; Agaricus bisporus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: METC 23-026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No