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NCT Number: NCT07048860

ICOPE INTENSE-K Pilot Study

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.

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Key information

Conditions

Ageing

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cité de la santé - Hopital La Grave

Toulouse, 31059, France

Location status: Recruiting

Location contact

Yves ROLLAND

CONTACT

[email protected]

0534557607

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICOPE intense intervention

Other

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

usual ICOPE Step 1

Primary outcomes

  1. Estimation of the effect size of the intervention on the cognitive function

    Time frame: 60 days

    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.

  2. Estimation of the effect size of the intervention on the muscle function

    Time frame: 60 days

    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

  3. Estimation of the effect size of the intervention on the immune function

    Time frame: 60 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yves ROLLAND

CONTACT

[email protected]

0534557607

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

A ICOPE Intense Program Combined With Ketone Ester Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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