Ireland
--:--IST
Recruiting Not applicable

Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups

NCT05389098 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-08-03
Last updated
2025-11-24

Condition(s) studied

UndernutritionElderly Person

Investigational drug(s) / intervention(s)

Hand-EatingControl

Hand-Eating: eat-hands type food mode

Control: Usual eating mode

Study 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 and improve the enjoyment of eating for residents.

Eligibility

Sex
ALL
Min age
75 Years
Max age
120 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • Audit & Questionnaire of feasibility — After 3 patients included and at the end of study (6 months)
    Feasibility of implementing finger food for elderly patients in care settings will be evaluate with audit and questionnaire for caregivers by a dietician independent of the study.

Trial sites (2)

FacilityCityRegionStatus
EHPAD " Val de Brenne " Site : Auzouer en Touraine Château-Renault France Not Yet Recruiting
EHPAD L'ERMITAGE-CHU de TOURS Tours France Recruiting
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 NCT05389098 on ClinicalTrials.gov ↗ ← All trials in France