Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 5:56 PM
Study NCT ID:
NCT07048860
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICOPE INTENSE-K Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2025-06-24', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of the effect size of the intervention on the cognitive function', 'timeFrame': '60 days', 'description': '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.'}, {'measure': 'Estimation of the effect size of the intervention on the muscle function', 'timeFrame': '60 days', 'description': '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:\n\n* Muscle endurance will be tested using the 6-min walk test\n* Lower body power assessed with the 5-time chair rise test\n* Muscle mass will be assessed using the Deuterated-Creatine Dilution approach'}, {'measure': 'Estimation of the effect size of the intervention on the immune function', 'timeFrame': '60 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognition', 'morbility', 'intrinsic capacity', 'biomarker of aging'], 'conditions': ['Ageing']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Independent-living (ADL ≥5/6)\n* Men and women\n* Mobility impairment (5 Chair-rise test \\>12 seconds)\n* Sedentarism (spend six or more hours per day sitting or lying down)\n* Positive screening for cognitive impairment according to the ICOPE screening tool with MMSE \\[25-28\\]\n* BMI ≥25 kg/m2\n\nExclusion Criteria:\n\n* Unintentional weight loss (≥10%) in past 6 months\n* Dementia\n* Life-threatening illnesses, with a life expectancy (judged by the investigating doctor) of less than 1 year\n* 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)\n* Organizational inability (three-time per week during the 60 days)\n* Living in a Nursing-Home\n* Under legal protection measure (guardianship, curatorship, safeguard of justice'}, 'identificationModule': {'nctId': 'NCT07048860', 'briefTitle': 'ICOPE INTENSE-K Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'A ICOPE Intense Program Combined With Ketone Ester Pilot Study', 'orgStudyIdInfo': {'id': 'RC31/24/0519'}, 'secondaryIdInfos': [{'id': '2025-A00891-48', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICOPE-intense group', 'description': 'ICOPE intense intervention + placebo', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'The ICOPE-intense + Ketone Ester (KE) group', 'description': 'ICOPE intense intervention + nutritional ketone esther suplementation', 'interventionNames': ['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']}, {'type': 'EXPERIMENTAL', 'label': 'The Ketone group', 'description': 'Usual ICOPE step 1 + ketone esther supplementation', 'interventionNames': ['Dietary Supplement: Ketone Ester (KE) supplementation', 'Other: ICOPE Step 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Usual ICOPE step 1 + placebo', 'interventionNames': ['Dietary Supplement: Placebo', 'Other: ICOPE Step 1']}], 'interventions': [{'name': 'ICOPE intense intervention', 'type': 'OTHER', 'description': '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)', 'armGroupLabels': ['ICOPE-intense group', 'The ICOPE-intense + Ketone Ester (KE) group']}, {'name': 'Ketone Ester (KE) supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': '12.5g once a day of KE for week 1, and 25g once a day of KE supplementation week 2 to week 8.', 'armGroupLabels': ['The ICOPE-intense + Ketone Ester (KE) group', 'The Ketone group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2.5 g of nonketogenic canola oil', 'armGroupLabels': ['Control group', 'ICOPE-intense group']}, {'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 sprays (i.e. 2000 iu) per day in the morning for 60 days', 'armGroupLabels': ['ICOPE-intense group', 'The ICOPE-intense + Ketone Ester (KE) group']}, {'name': 'OMega 3', 'type': 'DIETARY_SUPPLEMENT', 'description': '1000 mg: 1 table per day in the morning during 60 days', 'armGroupLabels': ['ICOPE-intense group', 'The ICOPE-intense + Ketone Ester (KE) group']}, {'name': 'vitamin B9', 'type': 'DIETARY_SUPPLEMENT', 'description': '5 mg cp: 1 tablet morning and 1 tablet evening for 60 days', 'armGroupLabels': ['ICOPE-intense group', 'The ICOPE-intense + Ketone Ester (KE) group']}, {'name': 'Vitamin B12', 'type': 'DIETARY_SUPPLEMENT', 'description': '250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days', 'armGroupLabels': ['ICOPE-intense group', 'The ICOPE-intense + Ketone Ester (KE) group']}, {'name': 'Leucin-rich whey', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In case of Sarcopenia or low protein intake (\\<1.2 g/kg/day), Oral Nutritional Supplementation enriched in essential amino acid (leucin)', 'armGroupLabels': ['ICOPE-intense group', 'The ICOPE-intense + Ketone Ester (KE) group']}, {'name': 'ICOPE Step 1', 'type': 'OTHER', 'description': 'usual ICOPE Step 1', 'armGroupLabels': ['Control group', 'The Ketone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yves ROLLAND', 'role': 'CONTACT', 'email': 'rolland.y@chu-toulouse.fr', 'phone': '0534557607'}], 'facility': 'Cité de la santé - Hopital La Grave', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Yves ROLLAND', 'role': 'CONTACT', 'email': 'rolland.y@chu-toulouse.fr', 'phone': '0534557607'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}