NCT05389098 Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups
| NCT ID | NCT05389098 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Tours |
| Condition | Undernutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-03 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-08-03 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 and improve the enjoyment of eating for residents.
Eligibility Criteria
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
Contact & Investigator
Laura COUTON
STUDY DIRECTOR
CHU Tours
Frequently Asked Questions
Who can join the NCT05389098 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, up to 120 Years, studying Undernutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05389098 currently recruiting?
Yes, NCT05389098 is actively recruiting participants. Contact the research team at L.COUTON@chu-tours.fr for enrollment information.
Where is the NCT05389098 trial being conducted?
This trial is being conducted at Château-Renault, France, Tours, France.
Who is sponsoring the NCT05389098 clinical trial?
NCT05389098 is sponsored by University Hospital, Tours. The principal investigator is Laura COUTON at CHU Tours. The trial plans to enroll 30 participants.