Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-07-09
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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ICOPE-intense group
ICOPE intense intervention + placebo
ICOPE intense intervention
The ICOPE-intense intervention (45 hours centre-based (in-group and in-person) multidomain intervention, everyday home-based lifestyle improvement, and weekly individual phone/video call for support)
Placebo
2.5 g of nonketogenic canola oil
Vitamin D3
2 sprays (i.e. 2000 iu) per day in the morning for 60 days
OMega 3
1000 mg: 1 table per day in the morning during 60 days
vitamin B9
5 mg cp: 1 tablet morning and 1 tablet evening for 60 days
Vitamin B12
250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days
Leucin-rich whey
In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)
The ICOPE-intense + Ketone Ester (KE) group
ICOPE intense intervention + nutritional ketone esther suplementation
ICOPE intense intervention
The ICOPE-intense intervention (45 hours centre-based (in-group and in-person) multidomain intervention, everyday home-based lifestyle improvement, and weekly individual phone/video call for support)
Ketone Ester (KE) supplementation
12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.
Vitamin D3
2 sprays (i.e. 2000 iu) per day in the morning for 60 days
OMega 3
1000 mg: 1 table per day in the morning during 60 days
vitamin B9
5 mg cp: 1 tablet morning and 1 tablet evening for 60 days
Vitamin B12
250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days
Leucin-rich whey
In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)
The Ketone group
Usual ICOPE step 1 + ketone esther supplementation
Ketone Ester (KE) supplementation
12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.
ICOPE Step 1
usual ICOPE Step 1
Control group
Usual ICOPE step 1 + placebo
Placebo
2.5 g of nonketogenic canola oil
ICOPE Step 1
usual ICOPE Step 1
Interventions
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ICOPE intense intervention
The ICOPE-intense intervention (45 hours centre-based (in-group and in-person) multidomain intervention, everyday home-based lifestyle improvement, and weekly individual phone/video call for support)
Ketone Ester (KE) supplementation
12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.
Placebo
2.5 g of nonketogenic canola oil
Vitamin D3
2 sprays (i.e. 2000 iu) per day in the morning for 60 days
OMega 3
1000 mg: 1 table per day in the morning during 60 days
vitamin B9
5 mg cp: 1 tablet morning and 1 tablet evening for 60 days
Vitamin B12
250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days
Leucin-rich whey
In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)
ICOPE Step 1
usual ICOPE Step 1
Eligibility Criteria
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Inclusion Criteria
* Men and women
* Mobility impairment (5 Chair-rise test \>12 seconds)
* Sedentarism (spend six or more hours per day sitting or lying down)
* Positive screening for cognitive impairment according to the ICOPE screening tool with MMSE \[25-28\]
* BMI ≥25 kg/m2
Exclusion Criteria
* Dementia
* Life-threatening illnesses, with a life expectancy (judged by the investigating doctor) of less than 1 year
* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina or any other contraindication to physical activity (as determined by a physician) or comorbid disease that would impair ability to participate in the ICOPE intense intervention such as renal failure on hemodialysis, severe psychiatric disorder (depressive participant will not be excluded)
* Organizational inability (three-time per week during the 60 days)
* Living in a Nursing-Home
* Under legal protection measure (guardianship, curatorship, safeguard of justice
65 Years
85 Years
ALL
Yes
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Locations
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Cité de la santé - Hopital La Grave
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A00891-48
Identifier Type: OTHER
Identifier Source: secondary_id
RC31/24/0519
Identifier Type: -
Identifier Source: org_study_id
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