Study of the Effect of the Consumption of a Combination of Allium Extracts on the Incidence of Symptoms of Respiratory Infections in Healthy Elderly Residents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Incidence of respiratory symptoms associated with infections.
研究概览
简要总结
To analyze the efficacy of daily consumption of a combination of garlic and onion extracts on the incidence of respiratory infection symptoms in healthy elderly volunteers living in a residence.
The duration of symptoms and related medication will also be studied.
详细描述
It is a controlled, randomized, double-blind, parallel-group nutritional intervention study.
66 healthy elderly volunteers living in a nursing home will be randomly distributed into 2 equal groups: control group and intervention group.
For 36 weeks the volunteers will take the product immediately after lunch. During that time they will maintain their lifestyle and nutritional habits.
Every 4 weeks, the medical team of the residence will review the cases of respiratory diseases of infectious origin of the volunteers.
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)
盲法说明
Each volunteer is assigned a "participant number" that will be associated with a pot that will have all the product for the study.
The "pot number" is the same as the "participant number". The pot does not indicate which product it is carrying.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Live in a nursing home with medical services.
- •Accept being vaccinated for the flu.
- •Freely accepted to participate in the study and sign the informed consent document.
- •Have the consent of the family.
排除标准
- •Having any disease that affects the development and results of the study.
- •Be unable to understand the study and sign voluntarily and freely the informed consent.
- •Have a low expectation of compliance with the study protocol.
结局指标
主要结局
Incidence of respiratory symptoms associated with infections.
时间窗: 36 weeks.
It will be reviewed if the volunteer has had any symptoms related to respiratory diseases of infectious origin.
次要结局
- Duration of symptoms.(36 weeks)
- Consumption of medicines.(36 weeks)