Evaluation of the Effect of the Consumption of a Combination of Allium Extracts on the Intestinal Microbiota in Healthy Elderly Resident Volunteers. Preliminary Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Short chain fatty acids in stool.
研究概览
简要总结
To evaluate the effect of daily consumption of a combination of garlic and onion extracts on the intestinal microbiota and the production of short chain fatty acids in elderly healthy volunteers living in a residence.
Likewise, any incident related to health that occurred during that period will be noted.
详细描述
This study is a continuation of another (C002, registration number NCT04647071).
The volunteers from study C002 were invited to participate in this new study and, by the end of C002, all gave 2 stool samples.
After 4 weeks of washout, the control group volunteers in C002 will begin consuming 1 capsule per day of garlic and onion extract after lunch. The intervention group volunteers in C002 will not consume anything.
During 36 weeks any incident related to the health of the volunteers will be noted. Likewise, during this time, the volunteers will maintain their lifestyle and eating habits.
At 36 weeks, 2 stool samples will be taken from all volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Each volunteer is assigned a "participant number" that is associated with the "pot number" that contains the product that the volunteer must take.
The "pot number" is the same as the "participant number". The pot does not indicate what 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
- •Men and women aged 65 years or older who participated in study C
- •Living in the Claret Residence for the Elderly in Granada during the study.
- •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
Short chain fatty acids in stool.
时间窗: 36 weeks.
Short chain fatty acids present in stool samples taken at the beginning and end of the study will be studied.
Changes in bacterial species in feces.
时间窗: 36 weeks.
The bacterial populations present in the stool samples taken at the beginning and at the end of the study will be studied.
次要结局
- Events during 36 weeks.(36 weeks)
- Medication during 36 weeks.(36 weeks)