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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
88
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
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
Participants have to consume 10 capsules per day containing 500 mg maltodextrin each, corresponding to a total maltodextrin intake of 5 g daily
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Vaccine specific antibody titer
The response to the Influenza vaccine will be measured by quantifying the 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))
Immune parameters (1)
Cytokine production by PBMCs after stimulation with antiCD3-antiCD28 antiCD28 antibodies using the TruCulture system
Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Immune parameters (2)
hsCRP
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (3)
Plasma glucose
Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (4)
Ergothioneine
Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (5)
Glutathione
Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Fasted metabolism (6)
Malondialdehyde
Time frame: Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study)
Anthropometry (1)
Body weight
Time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (2)
Height
Time frame: Day -1 (start study)
Anthropometry (3)
Waist circumference
Time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (4)
Hip circumference
Time frame: Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4)
Anthropometry (5)
Waist-to-hip ratio
Time frame: 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
Time frame: 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
Time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Diary outcomes (1)
Adverse events as assessed by the diary
Time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
Diary outcomes (2)
Medication intake as assessed by the diary
Time frame: Day - 1 (start study), T=4 weeks after vaccination (end of study)
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