RecruitingNot ApplicableNCT07048860

ICOPE INTENSE-K Pilot Study

A ICOPE Intense Program Combined With Ketone Ester Pilot Study


Sponsor

University Hospital, Toulouse

Enrollment

40 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 65 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying ICOPE Step 1, ICOPE intense intervention, and others for people with ageing. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERICOPE 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_SUPPLEMENTKetone 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_SUPPLEMENTPlacebo

2.5 g of nonketogenic canola oil

DIETARY_SUPPLEMENTVitamin D3

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

DIETARY_SUPPLEMENTOMega 3

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

DIETARY_SUPPLEMENTvitamin B9

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

DIETARY_SUPPLEMENTVitamin B12

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

DIETARY_SUPPLEMENTLeucin-rich whey

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

OTHERICOPE Step 1

usual ICOPE Step 1


Locations(1)

Cité de la santé - Hopital La Grave

Toulouse, France

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NCT07048860


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