Agaricus Bisporus and Influenza Vaccination Response
- Conditions
- Immune Response
- Interventions
- Dietary Supplement: Agaricus bisporus capsulesDietary Supplement: Control capsules
- Registration Number
- NCT06041867
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Influenza vaccine Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder Agaricus bisporus group Agaricus bisporus capsules Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each Agaricus bisporus group Influenza vaccine Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each Placebo group Control capsules Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder
- Primary Outcome Measures
Name Time Method Vaccine 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)) The response to the Influenza vaccine will be measured by quantifying the specific antibody titer
- Secondary Outcome Measures
Name Time Method Diary outcomes (2) Day - 1 (start study), T=4 weeks after vaccination (end of study) Medication intake as assessed by the diary
Anthropometry (4) Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Hip circumference
Anthropometry (5) Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Waist-to-hip ratio
Diary outcomes (1) Day - 1 (start study), T=4 weeks after vaccination (end of study) Adverse events as assessed by the diary
Fasted metabolism (1) Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) Serum non-cholesterol sterols and stanols
Fasted metabolism (2) Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) Serum lipid and lipoprotein profile
Anthropometry (2) Day -1 (start study) Height
Quality of life questionnaire 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
Immune parameters (1) 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
Leukocyte count Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) Number of leukocytes measured in EDTA plasma
Leukocyte differential count 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
Fasted metabolism (5) Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) Glutathione
Fasted metabolism (3) Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) Plasma glucose
Anthropometry (1) Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Body weight
Anthropometry (3) Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) Waist circumference
Immune parameters (2) Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) hsCRP
Fasted metabolism (4) Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) Ergothioneine
Fasted metabolism (6) Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study) Malondialdehyde
Diet 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
Trial Locations
- Locations (1)
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands