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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04360109
Other study ID # PI19/01524
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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