Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in level of reduced glutathione
研究概览
简要总结
A trial on acute antioxidant protection and immune effects when 24 people consume a novel nutraceutical blend compared to a placebo on different test days.
详细描述
A randomized, cross-over study design will be used to evaluate immune effects of consumption of 25 mg ergothioneine. On the first clinic day, participants will take a placebo with a one week wash out. Following the wash out week, participants will take 25 mg ergothioneine for 7 consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements
- •Willing to maintain a consistent diet and lifestyle routine throughout the study
- •Willing to avoid consumption of meals where the predominant ingredients include mushrooms, seafood, and organ meat (liver, heart).*
- •Willing to abstaining from exercising on the morning of a study visit
- •Willing to abstain from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit
- •Willing to abstain from music, candy, gum, computer/cell phone use, during clinic visits.
排除标准
- •Previous major gastrointestinal surgery
- •Active chronic immunological disease
- •Currently taking daily OTC medications, prescription pain medications, antipsychotic medications, anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects if the test product, nutritional supplements containing medicinal mushroom extracts
- •Diagnose with Type I diabetes, autoimmune disorders
- •Getting regular joint injections
- •Active severe chronic disease (such as HIV, chronic hepatitis)
- •Currently experiencing intense stressful events/ life changes
- •Currently in intensive athletic training
- •Experiencing an unusual sleep routine
- •Unwilling to maintain a constant intake of supplements over the duration of the study
- •Anxiety about having blood drawn
- •Women who are pregnant, nursing, or trying to become pregnant
- •Known food allergies to ingredients in test product
研究组 & 干预措施
Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily
Participants will consume placebo on first study day, consume 25mg of ergothioneine on second study day, then consume 25mg of ergothioneine daily for 1 week
干预措施: Placebo (Dietary Supplement)
Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily
Participants will consume placebo on first study day, consume 25mg of ergothioneine on second study day, then consume 25mg of ergothioneine daily for 1 week
干预措施: Ergothioneine, 25 miligrams (Dietary Supplement)
Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily
Participants will consume placebo on first study day, consume 25mg of ergothioneine on second study day, then consume 25mg of ergothioneine daily for 1 week
干预措施: Ergothioneine, 25 miligrams, daily for 1 week (Dietary Supplement)
结局指标
主要结局
Change in level of reduced glutathione
时间窗: 2 hours
Mean fluorescence
次要结局
- Change in mitochondrial mass and mitochondrial potential from baseline(2 hours)
研究者
Gitte Jensen, Ph.D.
Research Director
Natural Immune Systems Inc