Status:
RECRUITING
Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups
Lead Sponsor:
University Hospital, Tours
Conditions:
Undernutrition
Elderly Person
Eligibility:
All Genders
75-120 years
Phase:
NA
Brief Summary
Food is available in easy-to-grip bites that allow residents in care settings to use their fingers for food. This new way of eating can help limit weight loss, increase food intake, gain independence ...
Detailed Description
According to the Haute Autorité de Santé (HAS), undernutrition affects between 15 and 38% of elderly people living in institutions and between 50 and 60% of hospitalized elderly people. In addition, a...
Eligibility Criteria
Inclusion
- Male or female residents over 75 years old living in a Accommodation facility for dependent elderly people for at least 3 months
- Presenting at least one of the following 3 criteria:
- Unintentional weight loss ≥ 5% in 1 month
- Involuntary weight loss ≥ 10% in 6 months or compared to the usual weight or compared to the weight at entry to the EHPAD
- Confirmed sarcopenia:
- Male (at least one of the 2 criteria):
- Dynamometer (kg): \< 27 AND calf circumference (cm): \< 31
- Impedancemetry: appendicular muscle mass index \< 20 kg OR appendicular muscle mass index \< 7 kg/m²
- Woman (at least one of the 2 criteria):
- Dynamometer (kg): \< 16 AND calf circumference (cm): \< 31
- Impedancemetry: appendicular muscle mass index \< 15 kg OR appendicular muscle mass index \< 5.5 kg/m²
- Loss of autonomy according to the Tully scale \< 12/18 with a score of 2 or 3 on the item "Able to bite, chew, swallow without making false routes"
- Person having given free, informed and express consent
- Person having an affiliation to a social security scheme
Exclusion
- Protected person: safeguard of justice
- Swallowing disorder having a contra-indication to the texture of hand-eating meals.
- Lack of motor skills in both hands
- Specific diet: pleasure diet, salt-free, sugar-free, fiber-free, artificial nutrition
- Wearer of a pacemaker
Key Trial Info
Start Date :
August 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05389098
Start Date
August 3 2023
End Date
January 31 2027
Last Update
November 24 2025
Active Locations (2)
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1
EHPAD " Val de Brenne " Site : Auzouer en Touraine
Château-Renault, France, 37110
2
EHPAD L'ERMITAGE-CHU de TOURS
Tours, France, 37100