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Study of the Association Between Presbycusis With the Incidence of Frailty

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04360109
Enrollment
300
Registered
2020-04-24
Start date
2020-11-02
Completion date
2022-11-30
Last updated
2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty Syndrome, Oxidative Stress, Presbycusis

Brief 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.

Interventions

None listed

Sponsors

Universidad Europea de Madrid
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Age

Exclusion criteria

* Disease of the hearing system * Serious illness (e.g. tumor) * Dementia * Total dependence

Design outcomes

Primary

MeasureTime frameDescription
Auditory function6 monthsstudy 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).
Frailty6 monthsFragility 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.

Secondary

MeasureTime frameDescription
Determination of total polyphenols in urinemeasured twice in each volunteer, at the beginning and end of the study period (6 months)24-hour urine samples using the method Folin -Ciocalteu.
Blood analysis,It will be performed at the beginning and at end of the study period (6 months)routine biochemistry and determination of: carotenoids, vitamins E and D
MicrobiotaIt will be performed at the beginning and at end of the study period (6 months)Stool microbiota analysis

Countries

Spain

Contacts

Primary ContactRodríguez
carolina.sanchez2@universidadeuropea.es91- 683 93 60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026