Mushboost: Evaluating the Effect of Agaricus Bisporus Powder Intake on the Vaccination Response to an Influenza Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Vaccine specific antibody titer
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 59 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Agaricus bisporus group
Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each
干预措施: Influenza vaccine (Biological)
Agaricus bisporus group
Dietary supplement: 10 capsules containing 500 mg Agaricus bisporus powder each
干预措施: Agaricus bisporus capsules (Dietary Supplement)
Placebo group
Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder
干预措施: Influenza vaccine (Biological)
Placebo group
Dietary supplement: 10 placebo capsules, capsules that do not contain Agaricus bisporus powder
干预措施: Control capsules (Dietary Supplement)
结局指标
主要结局
Vaccine specific antibody titer
时间窗: 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
次要结局
- Diary outcomes (2)(Day - 1 (start study), T=4 weeks after vaccination (end of study))
- Anthropometry (4)(Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Anthropometry (5)(Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Diary outcomes (1)(Day - 1 (start study), T=4 weeks after vaccination (end of study))
- Fasted metabolism (1)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Fasted metabolism (2)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Anthropometry (2)(Day -1 (start study))
- Quality of life questionnaire(Day - 1 (start study), T=4 weeks after vaccination (end of study))
- Immune parameters (1)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Leukocyte count(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Leukocyte differential count(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Fasted metabolism (5)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Fasted metabolism (3)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Anthropometry (1)(Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Anthropometry (3)(Day - 1 (start study), T=0 (day before vaccination), weekly in the month after vaccination (T1-T4))
- Immune parameters (2)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Fasted metabolism (4)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Fasted metabolism (6)(Day - 1 (start study), T=0 (day before vaccination), T=4 weeks after vaccination (end of study))
- Diet(Day - 1 (start study), T=4 weeks after vaccination (end of study))