Actively Recruiting
A ICOPE Intense Program Combined With Ketone Ester Pilot Study
Led by University Hospital, Toulouse · Updated on 2025-07-23
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring a model called ICOPE to promote healthy aging by preventing declines in immunity, mobility, and cognitive function. This pilot study aims to measure the maximum impact that a strong non-drug intervention, combined with nutritional ketone supplementation, can have on key aging functions. The findings will serve as a reference for future studies on new anti-aging drugs or other nonpharmacological approaches. Participants receive one of four treatments: the intense ICOPE program alone, the intense ICOPE program plus ketone ester supplements, the usual ICOPE Step 1 program plus ketone supplements, or the usual ICOPE Step 1 program with a placebo. The intense program includes 45 hours of center-based group sessions, daily home lifestyle improvements, and weekly support calls. Ketone ester dosing starts with 12.5g daily in the first week, increasing to 25g daily for weeks 2 through 8. Additional dietary supplements like vitamin D3, omega-3, vitamins B9 and B12, and leucine-rich whey may be provided as needed. During the 60-day study, participants will be assessed on cognitive, muscle, and immune function to estimate the size of the intervention's effects. Evaluations include physical tests, cognitive screening, and monitoring of supplement adherence. Safety and ability to participate are closely monitored, with eligibility requiring independent living and certain mobility and cognitive criteria. The total study involvement lasts about two months, focusing on how the combined interventions influence aging-related functions.
CONDITIONS
Brief Title
ICOPE INTENSE-K Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Independent living with the ability to perform at least 5 out of 6 daily activities
- Men and women aged between 65 and 85 years
- Mobility impairment demonstrated by taking more than 12 seconds on a 5 Chair-rise test
- Sedentary lifestyle spending six or more hours per day sitting or lying down
- Positive screening for mild cognitive impairment using the ICOPE screening tool with MMSE scores between 25 and 28
- Body mass index of 25 kg/m2 or higher
You will not qualify if you...
- Unintentional weight loss of 10% or more in the past 6 months
- Diagnosis of dementia
- Life-threatening illnesses with less than 1 year life expectancy as judged by a doctor
- Severe heart conditions including advanced heart failure, aortic stenosis, history of cardiac arrest, use of cardiac defibrillator, uncontrolled angina, or any condition preventing physical activity
- Other serious health issues that impair ability to participate, such as kidney failure on dialysis or severe psychiatric disorders (except depression)
- Inability to participate in sessions three times per week for 60 days
- Living in a nursing home
- Under legal protection measures such as guardianship or curatorship
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 60 days
Participants receive the ICOPE intense program combined with dietary supplements including ketone ester or placebo over a 60-day period, involving center-based multidomain sessions, home-based lifestyle improvements, and weekly individual support calls.
Weekly visits for support calls and multiple in-person sessions over 60 days
Trial Site Locations
Total: 1 location
1
Cité de la santé - Hopital La Grave
Toulouse, France, 31059
Actively Recruiting
Research Team
Y
Yves ROLLAND
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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