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Recruiting NCT07048860

ICOPE INTENSE-K Pilot Study

No phase Interventional Ageing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICOPE intense intervention, Ketone Ester (KE) supplementation, Placebo, Vitamin D3.
Who it may be relevant to
Registry conditions: Ageing. Basic parameters: 65 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A ICOPE Intense Program Combined With Ketone Ester Pilot Study

Overview

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.

Detailed description

In this pilot study, the concept of prevention proposed by the WHO, for everyday life is taken to the extreme to be able to judge what is the maximum effect size on key functions of aging (mobility, cognition, immunity) that can be expected and achieved by a nonpharmacological intervention. The results obtained will constitute reference data for the future, during the investigation on new gerotherapeutic drugs or other nonpharmacological interventions. Taking into account the hypothesis of a synergistic effect between Ketones and non-pharmacological intervention, the intense ICOPE program makes it possible to study the effect size of Ketones under optimal experimental conditions.

Interventions

  • Other ICOPE intense 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)
  • Dietary supplement Ketone Ester (KE) supplementation
    12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.
  • Dietary supplement Placebo
    2.5 g of nonketogenic canola oil
  • Dietary supplement Vitamin D3
    2 sprays (i.e. 2000 iu) per day in the morning for 60 days
  • Dietary supplement OMega 3
    1000 mg: 1 table per day in the morning during 60 days
  • Dietary supplement vitamin B9
    5 mg cp: 1 tablet morning and 1 tablet evening for 60 days
  • Dietary supplement Vitamin B12
    250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days
  • Dietary supplement Leucin-rich whey
    In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)
  • Other ICOPE Step 1
    usual ICOPE Step 1

Primary outcome measures

  • Estimation of the effect size of the intervention on the cognitive function [Time frame: 60 days]
  • Estimation of the effect size of the intervention on the muscle function [Time frame: 60 days]
  • Estimation of the effect size of the intervention on the immune function [Time frame: 60 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

France · 1 center
  • Cité de la santé - Hopital La Grave — Toulouse

Identifiers

NCT: NCT07048860 · RC31/24/0519 · 2025-A00891-48

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗