Agaricus Bisporus and Influenza Vaccination Response

Immune Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041867
• Other study ID #: METC 23-026
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: February 2024
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: May 30, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 59 Years and older

Eligibility

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 (ß)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)

Related Conditions & MeSH terms

• Immune Response
• Influenza, Human

Intervention

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
• 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

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	CNC Grondstoffen B.V., Scelta Mycofriends B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

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