Study of the Association Between Presbycusis With the Incidence of Frailty

Oxidative Stress Clinical Trial

Official title:

Study of the Association Between Presbycusis With the Incidence of Frailty. Intake of Polyphenols for the Prevention of Presbycusis: Effects on Frailty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04360109
• Other study ID #: PI19/01524
• Status: Recruiting
• Start date: November 2, 2020
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: Universidad Europea de Madrid
• Contact: Rodríguez
• Phone: 91- 683 93 60
• Email: carolina.sanchez2[@]universidadeuropea.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age

Exclusion Criteria:

• Disease of the hearing system

• Serious illness (e.g. tumor)

• Dementia

• Total dependence

Related Conditions & MeSH terms

• Frailty
• Frailty Syndrome
• Oxidative Stress
• Presbycusis

Locations

Country	Name	City	State
Spain	Hospital Universitario de Getafe	Getafe	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory function	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).	6 months
Primary	Frailty	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.	6 months
Secondary	Determination of total polyphenols in urine	24-hour urine samples using the method Folin -Ciocalteu.	measured twice in each volunteer, at the beginning and end of the study period (6 months)
Secondary	Blood analysis,	routine biochemistry and determination of: carotenoids, vitamins E and D	It will be performed at the beginning and at end of the study period (6 months)
Secondary	Microbiota	Stool microbiota analysis	It will be performed at the beginning and at end of the study period (6 months)