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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de Getafe | Getafe | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Europea de Madrid |
Spain,
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) |
Status | Clinical Trial | Phase | |
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