ICOPE INTENSE-K program to improve mobility, thinking, and immune health in older adults
A ICOPE Intense Program Combined With Ketone Ester Pilot Study
This program will see if an intensive ICOPE lifestyle program combined with ketone ester supplements (or placebo), plus vitamin D3 and omega‑3, helps older adults with early mobility and thinking problems improve mobility, cognition, and immune-related aging markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT07048860 on ClinicalTrials.gov |
What this trial studies
This is a pilot interventional program testing a very intensive version of the WHO ICOPE nonpharmacological care model alongside ketone ester supplementation compared with placebo, with vitamin D3 and omega‑3 provided per protocol. Participants are community-dwelling older adults with mobility impairment, sedentary behavior, mild cognitive impairment on ICOPE/MMSE screening, and BMI ≥25. The study measures changes in key aging functions — mobility (chair‑rise), cognition, and biomarkers linked to immunosenescence — to estimate maximum effect sizes achievable with nonpharmacological care and ketone support. Results are intended to provide reference data for future geroscience trials and for comparing new gerotherapeutic drugs against a strong behavioral benchmark.
Who should consider this trial
Good fit: Ideal candidates are independent-living older adults who are sedentary, have mobility impairment (5‑chair rise >12 seconds), mild cognitive impairment on the ICOPE/MMSE screen (MMSE 25–28), and BMI ≥25 kg/m2.
Not a fit: People with dementia, recent unintentional weight loss ≥10%, severe cardiac disease or other conditions that prevent physical activity, life expectancy under one year, severe psychiatric disorders, or on hemodialysis are excluded and unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could slow or reduce declines in mobility, cognition, and immune aging using an intensive non-drug care program possibly enhanced by ketone supplementation.
How similar studies have performed: Some prior ICOPE and lifestyle-based interventions have shown functional benefits, but combining an intense ICOPE program with ketone ester supplementation is a novel approach that has limited prior large-scale evidence.
Eligibility criteria
Show full inclusion / exclusion 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) * Organizational inability (three-time per week during the 60 days) * Living in a Nursing-Home * Under legal protection measure (guardianship, curatorship, safeguard of justice
Where this trial is running
Toulouse
- Cité de la santé - Hopital La Grave — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Yves ROLLAND
- Email: rolland.y@chu-toulouse.fr
- Phone: 0534557607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.