An observational study in Frailty, Malnutrition and Anorexia, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 100 is below the median of 225 across 493 observational studies indexed under Frailty.
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Subjects 65 years of age or older, hospitalized in geriatrics or living in a nursing home.
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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
Subjects 65 years of age or older, hospitalized in geriatrics or EHPAD residents
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?"
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.
Time frame: a 10-min session
Evaluation of plesure felt
After eating each type of cookies, "Is it a pleasure?" question will be asked
Time frame: a 10-min session
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