NCT07048860

ICOPE INTENSE-K Pilot Study

A ICOPE Intense Program Combined With Ketone Ester Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Ageing

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-07-09
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-07-03
• Last updated: 2025-07-23

Locations

1 site across 1 country: France