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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
40
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)
12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.
2.5 g of nonketogenic canola oil
Cité de la santé - Hopital La Grave
Toulouse, France
RECRUITINGEstimation 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
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
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
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2 sprays (i.e. 2000 iu) per day in the morning for 60 days
1000 mg: 1 table per day in the morning during 60 days
5 mg cp: 1 tablet morning and 1 tablet evening for 60 days
250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days
In case of Sarcopenia or low protein intake (\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)
usual ICOPE Step 1