A ICOPE Intense Program Combined With Ketone Ester Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Estimation of the effect size of the intervention on the immune function
Study Overview
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.
Detailed Description
In this pilot study, the concept of prevention proposed by the WHO, for everyday life is taken to the extreme to be able to judge what is the maximum effect size on key functions of aging (mobility, cognition, immunity) that can be expected and achieved by a nonpharmacological intervention. The results obtained will constitute reference data for the future, during the investigation on new gerotherapeutic drugs or other nonpharmacological interventions. Taking into account the hypothesis of a synergistic effect between Ketones and non-pharmacological intervention, the intense ICOPE program makes it possible to study the effect size of Ketones under optimal experimental conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 65 Years to 85 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Outcomes
Primary Outcomes
Estimation of the effect size of the intervention on the immune function
Time Frame: 60 days
The analysis of immune function will be determined by the analysis of PBMC collected and bio banked at baseline and at 60 days. Specific assay decisions will be determined and fixed in 2026 by the scientific adversary board of the financer application.
Estimation of the effect size of the intervention on the cognitive function
Time Frame: 60 days
The cognitive function will be assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized neuropsychological test with a game-like and non-verbal environment that assesses the different cognitive domains, at baseline and day 60.
Estimation of the effect size of the intervention on the muscle function
Time Frame: 60 days
The muscle function will be assessed using 3 validated clinical approaches that investigate muscle endurance, muscle strength/power and muscle mass at baseline and day 60: * Muscle endurance will be tested using the 6-min walk test * Lower body power assessed with the 5-time chair rise test * Muscle mass will be assessed using the Deuterated-Creatine Dilution approach
Secondary Outcomes
No secondary outcomes reported