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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00891-48 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICOPE-intense group | Experimental | ICOPE intense intervention + placebo |
|
| The ICOPE-intense + Ketone Ester (KE) group | Experimental | ICOPE intense intervention + nutritional ketone esther suplementation |
|
| The Ketone group | Experimental | Usual ICOPE step 1 + ketone esther supplementation |
|
| Control group | Placebo Comparator | Usual ICOPE step 1 + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation 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. | 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:
| 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. | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yves ROLLAND | Contact | 0534557607 | rolland.y@chu-toulouse.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cité de la santé - Hopital La Grave | Recruiting | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D002762 | Cholecalciferol |
| D004281 | Docosahexaenoic Acids |
| D005492 | Folic Acid |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| 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 |
|
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |