[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596698":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":40,"centralContacts":74,"locations":80,"responsibleParty":96,"collaborators":40,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":40,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":40,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":83,"whyStopped":40,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,20,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"ICOPE-intense group","EXPERIMENTAL","ICOPE intense intervention + placebo",[13,14,15,16,17,18,19],"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",{"label":21,"type":10,"description":22,"interventionNames":23},"The ICOPE-intense + Ketone Ester (KE) group","ICOPE intense intervention + nutritional ketone esther suplementation",[13,24,15,16,17,18,19],"Dietary Supplement: Ketone Ester (KE) supplementation",{"label":26,"type":10,"description":27,"interventionNames":28},"The Ketone group","Usual ICOPE step 1 + ketone esther supplementation",[24,29],"Other: ICOPE Step 1",{"label":31,"type":32,"description":33,"interventionNames":34},"Control group","PLACEBO_COMPARATOR","Usual ICOPE step 1 + placebo",[14,29],[36,41,46,50,54,58,62,66,70],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"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\u002Fvideo call for support)",[9,21],null,{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":40},"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.",[21,26],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":40},"Placebo","2.5 g of nonketogenic canola oil",[31,9],{"type":42,"name":51,"description":52,"armGroupLabels":53,"otherNames":40},"Vitamin D3","2 sprays (i.e. 2000 iu) per day in the morning for 60 days",[9,21],{"type":42,"name":55,"description":56,"armGroupLabels":57,"otherNames":40},"OMega 3","1000 mg: 1 table per day in the morning during 60 days",[9,21],{"type":42,"name":59,"description":60,"armGroupLabels":61,"otherNames":40},"vitamin B9","5 mg cp: 1 tablet morning and 1 tablet evening for 60 days",[9,21],{"type":42,"name":63,"description":64,"armGroupLabels":65,"otherNames":40},"Vitamin B12","250 microgram: 1 tablet per day in the morning for 30 days, then 1 tablet every 10 days for 30 days",[9,21],{"type":42,"name":67,"description":68,"armGroupLabels":69,"otherNames":40},"Leucin-rich whey","In case of Sarcopenia or low protein intake (\\\u003C1.2 g\u002Fkg\u002Fday), Oral Nutritional Supplementation enriched in essential amino acid (leucin)",[9,21],{"type":6,"name":71,"description":72,"armGroupLabels":73,"otherNames":40},"ICOPE Step 1","usual ICOPE Step 1",[31,26],[75],{"name":76,"role":77,"phone":78,"phoneExt":40,"email":79},"Yves ROLLAND","CONTACT","0534557607","rolland.y@chu-toulouse.fr",[81],{"facility":82,"status":83,"city":84,"state":40,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Cité de la santé - Hopital La Grave","RECRUITING","Toulouse","31059","France","FR",{"type":89,"coordinates":90},"Point",[91,92],1.44367,43.60426,{"lat":92,"lon":91},[95],{"name":76,"role":77,"phone":78,"phoneExt":40,"email":79},{"type":97,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100596698","icope-intense-k-pilot-study-100596698",false,"NCT07048860","ICOPE INTENSE-K Pilot Study","A ICOPE Intense Program Combined With Ketone Ester Pilot Study","Inclusion Criteria:\n\n* Independent-living (ADL ≥5\u002F6)\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\u002Fm2\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",true,"ALL","65 Years","85 Years",{"count":110,"type":111},40,"ESTIMATED","INTERVENTIONAL",[114],"NA","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.",[117],"Ageing",[119,120,121,122],"cognition","morbility","intrinsic capacity","biomarker of aging","2025-07-22",{"date":125,"type":126},"2025-07-23","ACTUAL",{"date":128,"type":126},"2025-07-09",{"date":130,"type":111},"2025-12-31",{"name":5,"class":6},1]