AgeingNCT07048860
ICOPE INTENSE-K Pilot Study
A study testing ICOPE intense intervention, Ketone Ester (KE) supplementation and Vitamin D3 in people with Ageing, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ageing
- What is being tested?
- ICOPE intense intervention, Ketone Ester (KE) supplementation and Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Cité de la santé - Hopital La Grave
Toulouse, 31059
Yves ROLLAND, 0534557607, rolland.y@chu-toulouse.fr
About this study
Official title: A ICOPE Intense Program Combined With Ketone Ester 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.
Read the 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
- Being tested
- ICOPE intense intervention, Ketone Ester (KE) supplementation, Placebo, Vitamin D3, OMega 3
- Keywords
- cognition, morbility, intrinsic capacity, biomarker of aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICOPE intense interventionOther
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) supplementationDietary supplement
12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.
PlaceboDietary supplement
2.5 g of nonketogenic canola oil
Vitamin D3Dietary supplement
2 sprays (i.e. 2000 iu) per day in the morning for 60 days
OMega 3Dietary supplement
1000 mg: 1 table per day in the morning during 60 days
vitamin B9Dietary supplement
5 mg cp: 1 tablet morning and 1 tablet evening for 60 days
Vitamin B12Dietary supplement
250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days
Leucin-rich wheyDietary 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 1Other
usual ICOPE Step 1
| Study group | Role | What they receive |
|---|---|---|
| ICOPE-intense group | Experimental | ICOPE intense intervention + placebo Receives: Other: ICOPE intense intervention; Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: OMega 3; Dietary Supplement: vitamin B9; Dietary Supplement: Vitamin B12; Dietary Supplement: Leucin-rich whey |
| The ICOPE-intense + Ketone Ester (KE) group | Experimental | ICOPE intense intervention + nutritional ketone esther suplementation Receives: Other: ICOPE intense intervention; Dietary Supplement: Ketone Ester (KE) supplementation; Dietary Supplement: Vitamin D3; Dietary Supplement: OMega 3; Dietary Supplement: vitamin B9; Dietary Supplement: Vitamin B12; Dietary Supplement: Leucin-rich whey |
| The Ketone group | Experimental | Usual ICOPE step 1 + ketone esther supplementation Receives: Dietary Supplement: Ketone Ester (KE) supplementation; Other: ICOPE Step 1 |
| Control group | Placebo comparator | Usual ICOPE step 1 + placebo Receives: Dietary Supplement: Placebo; Other: ICOPE Step 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start9 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048860
- Sponsor's protocol ID
- RC31/24/0519
- Other IDs
- 2025-A00891-48
- Status last verified
- Jul 2025
- First submitted
- 19 Dec 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A ICOPE Intense Program Combined With Ketone Ester Pilot Study
- ClinicalTrials.gov ID
- NCT07048860
- Acronym / sponsor ID
- RC31/24/0519
- Conditions
- Ageing
- Keywords
- cognition, morbility, intrinsic capacity, biomarker of aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICOPE-intense group | Experimental | Other: ICOPE intense intervention, Dietary Supplement: Placebo, Dietary Supplement: Vitamin D3, Dietary Supplement: OMega 3, Dietary Supplement: vitamin B9, Dietary Supplement: Vitamin B12, Dietary Supplement: Leucin-rich wheyICOPE intense intervention + placebo |
| The ICOPE-intense + Ketone Ester (KE) group | Experimental | Other: ICOPE intense intervention, Dietary Supplement: Ketone Ester (KE) supplementation, Dietary Supplement: Vitamin D3, Dietary Supplement: OMega 3, Dietary Supplement: vitamin B9, Dietary Supplement: Vitamin B12, Dietary Supplement: Leucin-rich wheyICOPE intense intervention + nutritional ketone esther suplementation |
| The Ketone group | Experimental | Dietary Supplement: Ketone Ester (KE) supplementation, Other: ICOPE Step 1Usual ICOPE step 1 + ketone esther supplementation |
| Control group | Placebo comparator | Dietary Supplement: Placebo, Other: ICOPE Step 1Usual ICOPE step 1 + placebo |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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]
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICOPE intense interventionThe 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) | Other | ICOPE-intense group, The ICOPE-intense + Ketone Ester (KE) group |
| Ketone Ester (KE) supplementation12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8. | Dietary supplement | The ICOPE-intense + Ketone Ester (KE) group, The Ketone group |
| Placebo2.5 g of nonketogenic canola oil | Dietary supplement | Control group, ICOPE-intense group |
| Vitamin D32 sprays (i.e. 2000 iu) per day in the morning for 60 days | Dietary supplement | ICOPE-intense group, The ICOPE-intense + Ketone Ester (KE) group |
| OMega 31000 mg: 1 table per day in the morning during 60 days | Dietary supplement | ICOPE-intense group, The ICOPE-intense + Ketone Ester (KE) group |
| vitamin B95 mg cp: 1 tablet morning and 1 tablet evening for 60 days | Dietary supplement | ICOPE-intense group, The ICOPE-intense + Ketone Ester (KE) group |
| Vitamin B12250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days | Dietary supplement | ICOPE-intense group, The ICOPE-intense + Ketone Ester (KE) group |
| Leucin-rich wheyIn case of Sarcopenia or low protein intake (<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin) | Dietary supplement | ICOPE-intense group, The ICOPE-intense + Ketone Ester (KE) group |
| ICOPE Step 1usual ICOPE Step 1 | Other | Control group, The Ketone group |
Primary outcome
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICOPE intense intervention, Ketone Ester (KE) supplementation and Vitamin D3 in people with Ageing, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yves ROLLAND (0534557607, rolland.y@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the effect size of the intervention on the cognitive function (time frame: 60 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.