Effectiveness of an Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 543
- 试验地点
- 2
- 主要终点
- Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.
研究概览
简要总结
The primary objective of this study is to determine the effect of an encapsulated juice powder concentrate on the number of days with at least moderate common cold symptoms over winter time.
详细描述
Common cold is the most frequent acute illness in industrialised societies. Though it is usually benign, it is a leading cause of absence from work and doctor visits, causing an enormous economic burden including lost productivity and treatment costs.
Common cold is caused by a variety of viruses, with rhinoviruses and corona viruses as the most common. There is currently no treatment for common cold, thus therapy is focussed on symptom relief only. Prevention strategies for common cold include lifestyle measures such as avoiding infected people and regular hand washing during cold season. Dietary supplements including herbs and vitamins have been suggested as preventive strategies for common cold.
Juice Plus+® is a dietary supplement composed primarily of juice powder concentrate and pulp from fruits and vegetables. It contains several antioxidants including vitamin C, vitamin E, beta-carotene and folate. One randomized study reported reduction in work days lost to illness in the Juice Plus+® group compared to the placebo group. However, the clinical benefit for preventing common cold symptoms has not yet been tested in a large adult population.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male, 18-65 years of age.
- •Able and willing to take the active or placebo capsules over the whole study period.
- •Health care professionals with essential patient contact (physicians, nurses, physiotherapists, etc) in Berlin, Germany.
- •Written informed consent.
排除标准
- •Known or suspected hypersensitivity or allergy to one of the ingredients of Juice Plus+®.
- •Refusal to stop intake of additional vitamin supplements during study.
- •Pregnancy or Lactation.
- •Alcohol addiction, drug abuse or any other condition considered by the investigator to interfere with study procedures.
- •Language limitations regarding interviews and questionnaires.
结局指标
主要结局
Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.
时间窗: within 6 months (after 2 months run-in period)
次要结局
- Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs(Baseline, months 2,4,6,8.)