Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ICOPE intense intervention

    Other intervention

    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)

  • Ketone Ester (KE) supplementation

    Dietary supplement

    12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.

  • Placebo

    Dietary supplement

    2.5 g of nonketogenic canola oil

  • Vitamin D3

    Dietary supplement

    2 sprays (i.e. 2000 iu) per day in the morning for 60 days

  • OMega 3

    Dietary supplement

    1000 mg: 1 table per day in the morning during 60 days

  • vitamin B9

    Dietary supplement

    5 mg cp: 1 tablet morning and 1 tablet evening for 60 days

  • Vitamin B12

    Dietary supplement

    250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days

  • Leucin-rich whey

    Dietary supplement

    In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)

  • ICOPE Step 1

    Other intervention

    usual ICOPE Step 1

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: ICOPE-intense groupExperimental treatment 7 interventions
Group B: The ICOPE-intense + Ketone Ester (KE) groupExperimental treatment 7 interventions
Group C: The Ketone groupExperimental treatment 2 interventions
Group D: Control groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
60 days
2

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

Time frame
60 days
3

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.

Time frame
60 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
Apply now