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FrailtyEDERE 2021NCT04923087

Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)

An observational study of Frailty and Malnutrition, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Frailty, Malnutrition, Anorexia
What is being tested?
Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements
Type of treatment
Medical device
How many people
100 participants
Where
1 siteFrance
Study dates
1 Jun 2021to 25 Jun 2027
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Subjects 65 years of age or older, hospitalized in geriatrics or living in a nursing home.

Who may be able to join

  • Subjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents.

Who cannot join

  • risk of false route when eating cookies, allergy to an ingredient in cookies

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Claire LASSAUZAY, PhD contact

+334 92 03 32 72

lassauzay.c@chu-nice.fr

France1 site, 1 recruiting
  • CHU de NICE

    Nice, 06000

    CHU de NICE Odonthologie, +334 92 03 32 72, pouyssegur-rougier.v@chu-nice.fr

    Claire LASSAUZAY, +33492033272, lassauzay.c@chu-nice.fr

    Recruiting

Other trials in France

About this study

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

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.

Being tested
Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements
Medical subject headings
Frailty, Malnutrition, Anorexia, Presbycusis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compare the noise and pleasure of crunching between two hyperprotein nutritional supplementsDevice

    Validate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?"

Study groups in NCT04923087
Study groupRoleWhat they receive
Patient hospitalized in geriatrics or EHPADSubjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents
Receives: Device: Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: a 10-min session

Secondary outcomes (1)
  1. Evaluation of plesure felt

    After eating each type of cookies, "Is it a pleasure?" question will be asked

    Measured: a 10-min session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completion31 Aug 2021
  4. Study completion25 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04923087
Sponsor's protocol ID
21odonto03
Acronym
EDERE 2021
Status last verified
Jun 2026
First submitted
4 Jun 2021
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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