Clinical trial Recruiting at 1 site Interventional Ages 65 to 85

ICOPE INTENSE-K program to improve mobility, thinking, and immune health in older adults

Official title: A ICOPE Intense Program Combined With Ketone Ester Pilot Study

Run by University Hospital, Toulouse · NCT07048860 · Data updated 2026-11-12

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

Study typeInterventional
Ages65 Years to 85 Years
SexAll
Enrollment40 (estimated)
SponsorUniversity Hospital, Toulouse
Academic / other
Locations1 site (Toulouse)
StatusRecruiting
StartedJuly 9, 2025
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedJuly 23, 2025
Trial IDNCT07048860 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Cité de la santé - Hopital La Grave
    Toulouse, France
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.