ICOPE INTENSE-K Pilot Study
A ICOPE Intense Program Combined With Ketone Ester Pilot Study
University Hospital, Toulouse
40 participants
Jul 9, 2025
INTERVENTIONAL
Summary
ICOPE could constitute the reference model of care for healthy aging. More specifically, our hypothesis is that the intervention implemented in ICOPE may directly or indirectly prevent immuno-senescence, the loss of mobility and the cognitive decline. In future Geroscience clinical trials, ICOPE-Intense could become a benchmark to reduce the rate of aging with a strong non-pharmacological intervention and state a reference intervention to compare with new gerotherapeutic drugs.
Eligibility
Inclusion Criteria6
- Independent-living (ADL ≥5/6)
- 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 Criteria7
- Unintentional weight loss (≥10%) in past 6 months
- 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
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Interventions
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)
12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.
2.5 g of nonketogenic canola oil
2 sprays (i.e. 2000 iu) per day in the morning for 60 days
1000 mg: 1 table per day in the morning during 60 days
5 mg cp: 1 tablet morning and 1 tablet evening for 60 days
250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days
In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)
usual ICOPE Step 1
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07048860