ICOPE INTENSE-K Pilot Study
A ICOPE Intense Program Combined With Ketone Ester Pilot Study
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2025
CompletedStudy Start
First participant enrolled
July 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJuly 23, 2025
July 1, 2025
6 months
December 19, 2024
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Estimation of the effect size of the intervention on the cognitive function
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.
60 days
Estimation of the effect size of the intervention on the muscle function
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
60 days
Estimation of the effect size of the intervention on the immune function
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.
60 days
Study Arms (4)
ICOPE-intense group
EXPERIMENTALICOPE intense intervention + placebo
The ICOPE-intense + Ketone Ester (KE) group
EXPERIMENTALICOPE intense intervention + nutritional ketone esther suplementation
The Ketone group
EXPERIMENTALUsual ICOPE step 1 + ketone esther supplementation
Control group
PLACEBO COMPARATORUsual ICOPE step 1 + placebo
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 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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cité de la santé - Hopital La Grave
Toulouse, 31059, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2024
First Posted
July 3, 2025
Study Start
July 9, 2025
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
July 23, 2025
Record last verified: 2025-07