ICOPE INTENSE-K Pilot Study
ConditionAgeing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorUniversity Hospital, Toulouse
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- ICOPE intense intervention
- Ketone Ester (KE) supplementation
- Placebo
- Vitamin D3
- OMega 3
- vitamin B9
- Vitamin B12
- Leucin-rich whey
- ICOPE Step 1
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov