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| Name | Class |
|---|---|
| Scelta Mycofriends B.V. | UNKNOWN |
| CNC Grondstoffen B.V. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Agaricus bisporus group | Experimental | Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each |
|
| Placebo group | Placebo Comparator | Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | 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 |
| 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)) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229 ER | Netherlands |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Agaricus bisporus capsules | Dietary 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 capsules | Dietary Supplement | Participants have to consume 10 capsules per day containing 500 mg maltodextrin each, corresponding to a total maltodextrin intake of 5 g daily |
|
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) |
| 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 (1) | Body weight | Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4) |
| Anthropometry (2) | Height | Day -1 (start study) |
| 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) |
| 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) |
| 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) |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |