A Randomized Controlled Study on the Effects of Tea Catechin Consumption on the Prevention of Influenza Infection in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- the incidence rates of influenza infection
研究概览
简要总结
The Purpose of this study is to evaluate the effects of 5 months catechin consumption on the prevention of influenza infection.
详细描述
Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent experimental studies have revealed that tea catechin extracts prevent influenza infection, but few studies have been conducted on the clinical effects of tea catechin consumption on the prophylaxis of influenza infection. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of 5 months tea catechin consumption on the prophylaxis of influenza infection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged over 20 years
- •possible to maintain without drinking tea more than 250 ml per day during the study
- •possible to maintain without taking supplements or herbal products including catechin extracts during the study
- •possible to fill out a questionnaire personally
- •Obtained written informed consent before participation
排除标准
- •Possessing some chronic infectious diseases in need of therapy
- •Possessing tea or catechin allergy
- •Possessing a history of influenza infection before six months prior to the study
- •diagnosed as inadequate for other reasons to participate the study by principal investigator
结局指标
主要结局
the incidence rates of influenza infection
时间窗: Until 5 months consumption of the study capsules
次要结局
- the incidence rates of upper respiratory tract infections(Until 5 months consumption of the study capsules)
- the severity of the symptoms and the duration of the cold among incident cases(Until 5 months consumption of the study capsules)
- occurrence of the adverse events(Until 5 months consumption of the study capsules)
研究者
Masahiro Morikawa
Clinical Trials management office
University of Shizuoka