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
Study 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
Sex
ALL
Min age
65 Years
Max age
85 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Cité de la santé - Hopital La Grave
Toulouse
France
Recruiting
More University Hospital, Toulouse trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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