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Clinical Trials in France / NCT04923087
Recruiting Observational

Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)

NCT04923087 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2021-06-01
Last updated
2026-06-29

Condition(s) studied

FrailtyMalnutritionAnorexiaPresbycusisEdentulism Nos

Investigational drug(s) / intervention(s)

Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements

Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements: Validate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?"

Study summary

Background. Decreased taste and smell contribute to loss of appetite (anorexia), and the resulting protein-energy malnutrition increases the frailty of the elderly. The risk of falls, disability, infections and depression often requires them to be institutionalized. Elderly, undernourished and toothless patients often complain about the monotony of a soft, mixed-texture diet. In a previous study, some participants highlighted the pleasure of crunching cookies that have a solid texture that can be eaten in any dental condition. However, the age-related decrease in hearing (presbyacusis) is frequent and progressive from the age of 60. The hypothesis of this work is that older patients may perceive a crunchy food crunching in their mouth, despite presbycusis. If the hypothesis is verified, this would make geriatric caregivers aware of the possibility of diversifying the texture of food, in order to stimulate the pleasure of eating and increase the dietary intake in this population of patients who are often undernourished, dysphagic, edentulous and hearing impaired. The originality of this study is to share the expertise of geriatricians and specialists in mastication/swallowing (dental surgeon, speech-language pathologist), hearing (ENT doctor, hearing care professional) and nutrition (dietician).

Type of study. Type of study MR-004 "Research not involving the human person". Protocol. Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements: a soft filled cookie (Nutra Cake™, Délical, France) and a crunchy cookie of the Breton type (Protibis™, Solidages, France). Blind study impossible: each subject will eat a cookie then the other in a random order and will be his own control. The tests will be performed without the possible hearing aids, but with or without the dentures according to the patient's preference. Indeed, some patients have dental prostheses that are no longer suitable for chewing, and that they wear only for aesthetics. Objective. Validate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?" If so, encourage diversification with crunchy foods with a suitable texture, as well as dental and prosthetic rehabilitation of dependent elderly people.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: Subjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents. Exclusion Criteria: risk of false route when eating cookies, allergy to an ingredient in cookies

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU de NICE Nice France Recruiting

More Centre Hospitalier Universitaire de Nice trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04923087 on ClinicalTrials.gov ↗ ← All trials in France