Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)

Malnutrition Clinical Trial

— EDERE 2021  

Official title:

Impact of Auditory Stimulation in Eating Pleasure : Multicentric Study With Biscuits With Crunchy Texture vs Soft Texture in 100 Seniors Affected or at Risk of Presbyacusis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923087
• Other study ID #: 21odonto03
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Valérie POUYSSEGUR, MD
• Phone: +334 92 03 32 72
• Email: pouyssegur-rougier.v[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Edentulism Nos
• Frailty
• Malnutrition
• Presbycusis

Intervention

Device:
• 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?"

Locations

Country	Name	City	State
France	CHU de NICE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception of crunching despite presbycusis	Subjects will be invited to eat two types of protein-rich cookies : Protibis (Solidages, France) and Nautre Cake (Delical, France). "Do you hear the biscuit crunch?" question will be asked.	a 10-min session
Secondary	Evaluation of plesure felt	After eating each type of cookies, "Is it a pleasure?" question will be asked	a 10-min session