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Recruiting NCT07048860

ICOPE INTENSE-K Pilot Study

Trial Parameters

Condition Ageing
Sponsor University Hospital, Toulouse
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 65 Years
Max Age 85 Years
Start Date 2025-07-09
Completion 2025-12-31
Interventions
ICOPE intense interventionKetone Ester (KE) supplementationPlacebo

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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)

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