Ageing
Conditions
Keywords
cognition, morbility, intrinsic capacity, biomarker of aging
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.
Interventions
OTHERICOPE 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)
DIETARY_SUPPLEMENTKetone 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.
DIETARY_SUPPLEMENTPlacebo
2.5 g of nonketogenic canola oil
DIETARY_SUPPLEMENTVitamin D3
2 sprays (i.e. 2000 iu) per day in the morning for 60 days
DIETARY_SUPPLEMENTOMega 3
1000 mg: 1 table per day in the morning during 60 days
DIETARY_SUPPLEMENTvitamin B9
5 mg cp: 1 tablet morning and 1 tablet evening for 60 days
DIETARY_SUPPLEMENTVitamin B12
250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days
DIETARY_SUPPLEMENTLeucin-rich whey
In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)
OTHERICOPE Step 1
usual ICOPE Step 1
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of the effect size of the intervention on the cognitive function | 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 | 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 |
| Estimation of the effect size of the intervention on the immune function | 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. |
Countries
France
Contacts
Primary ContactYves ROLLAND
Outcome results
None listed