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New treatment option for Undernutrition
Official title Finger Food, Pleasure at Your Fingertips: Randomized Pilot Study, Open-label and Parallel Groups
ClinicalTrials.gov ID: NCT05389098
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 to 120. Healthy volunteers may be eligible.
You may be able to join if
- 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:
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Château-Renault, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years to 120 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Château-Renault, France; Tours, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.