Study of the Association Between Presbycusis With the Incidence of Frailty. Intake of Polyphenols for the Prevention of Presbycusis: Effects on Frailty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Auditory function
研究概览
简要总结
The objective of the project is to establish the association between presbycusis and the incidence of frailty in humans in order to establish hearing loss with age as another index for the diagnosis of frailty; As well as studying the effect of exposure to polyphenols in the diet on presbycusis and frailty. Human study: volunteers between 60 and 99 years old, men and women during a period of 6 months, questions and answers, audiometries, study of fragility, analysis of antioxidants in blood, and samples of urine will be measured Total polyphenols and oxidant capacity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Disease of the hearing system
- •Serious illness (e.g. tumor)
- •Total dependence
结局指标
主要结局
Auditory function
时间窗: 6 months
study by pure tone audiometry, calculating an average of the thresholds of hearing at 0.5, 1, 2 and 4 kilohertz classifying according to their hearing thresholds to the participants in: normal hearing ≤ 25decibel, slight hearing loss = 26-40 decibel; Y moderate-greater hearing loss\> 40 decibel (according to the World Health Organization).
Frailty
时间窗: 6 months
Fragility will be determined at the beginning and at the end of the study period using the 5 Fried indexes: weakness, low speed, low physical activity, exhaustion and weight loss. Participants with 3 or more criteria are classified as fragile, with 1-2 criteria as pre-fragile, and those without any criteria are not considered fragile. Thus, individuals will be classified in the analyzes as non-fragile, pre-fragile and fragile.
次要结局
- Microbiota(It will be performed at the beginning and at end of the study period (6 months))
- Determination of total polyphenols in urine(measured twice in each volunteer, at the beginning and end of the study period (6 months))
- Blood analysis,(It will be performed at the beginning and at end of the study period (6 months))
研究者
Carolina Sánchez Rodríguez
Principal Investigator
Universidad Europea de Madrid