[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606956":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":41,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":26,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Fundacion Miguel Servet","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Experimental - Combined Exercise + Anti-Inflammatory Supplement (Alisenoc™)","EXPERIMENTAL","Participants included in this group will perform physical exercise (Vivifrail) + Anti-Inflammatory Supplement",[13],"Dietary Supplement: Anti-Inflammatory Supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: Active Comparator - Exercise + Conventional Nutritional Supplement","ACTIVE_COMPARATOR","Participants included in this group will perform physical exercise (Vivifrail) + Conventional Nutritional Supplement",[19],"Dietary Supplement: Conventional Nutritional Supplement",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Anti-Inflammatory Supplement","A daily oral dose of Alisenoc™, an anti-inflammatory nutritional supplement specifically designed for older adults. Alisenoc™ contains olive oil polyphenols, omega-3 fatty acids (EPA\u002FDHA), leucine-enriched protein, and antioxidant micronutrients to target inflammaging, sarcopenia, and nutritional deficiencies.\n\nParticipants will be followed at 12 weeks, and at 6 and 12 months for functional, biochemical, and clinical outcomes.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional Nutritional Supplement","they will receive a conventional oral nutritional supplement that is isocaloric and protein-equivalent to the experimental product, but without anti-inflammatory ingredients.\n\nThis standard supplement reflects routine nutritional support typically provided in geriatric clinical practice for malnourished patients. It contains energy, protein, and micronutrients but no specific anti-inflammatory components such as olive polyphenols or omega-3 fatty acids.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Bernardo Abel Cedeno-Veloz, MD PhD","CONTACT","0034637418620","ba.cedeno.veloz@navarra.es",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Nicolás Martínez-Velilla, MD PhD","0034670900434","nicolas.martinez.velilla@navarra.es",{"type":42,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[44],{"name":45,"class":46},"Adventia Pharma","INDUSTRY","100606956","effect-of-a-combined-exercise-and-anti-inflammatory-nutritional-intervention-in-frail-older-adults-100606956",false,"NCT07182292","Effect of a Combined Exercise and Anti-Inflammatory Nutritional Intervention in Frail Older Adults","Effectiveness of Combined Therapeutic Exercise and Anti-Inflammatory Nutritional Supplementation in Frail, Malnourished Older Adults","AliFrail","Inclusion Criteria:\n\n* Patient aged ≥ 75 years.\n* Diagnosis of frailty according to Linda Fried's criteria.\n* Diagnosis of malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria.\n* Barthel Index score ≥ 60 points.\n* Absence of advanced chronic kidney disease (defined as glomerular filtration rate \\\u003C 25 mL\u002Fmin\u002F1.73m²).\n* Absence of terminal illness as defined by SECPAL (Spanish Society for Palliative Care) criteria.\n\nExclusion Criteria:\n\n* Presence of type 1 or type 2 diabetes mellitus with poor metabolic control (HbA1c \\> 8% or insulin-dependent).\n* Oropharyngeal dysphagia to liquids that prevents safe intake of oral supplementation.\n* Moderate-to-severe cognitive impairment, defined as a score ≥ 5 on the Global Deterioration Scale (GDS) of Reisberg.\n* Refusal to sign the informed consent by the patient, primary caregiver, or legal representative, or inability to obtain it.\n* Known allergy or intolerance to any component of the study supplements.\n* Institutionalized in a long-term care or residential facility.","ALL","75 Years",{"count":58,"type":59},158,"ESTIMATED","INTERVENTIONAL",[62],"NA","The goal of this clinical trial is to evaluate whether a combined intervention of therapeutic exercise and anti-inflammatory nutritional supplementation improves physical performance and reduces systemic inflammation in frail, malnourished older adults. The main questions it aims to answer are:\n\nDoes the addition of an anti-inflammatory nutritional supplement (Alisenoc™) to a multicomponent exercise program (Vivifrail) lead to greater improvements in physical performance compared to standard exercise and conventional nutritional support?\n\nDoes the combined intervention reduce levels of inflammatory biomarkers (e.g., IL-6, TNF-α, IL-8, GDF-15) in this population?\n\nAre there measurable changes in body composition (e.g., muscle mass, fat mass, bone health) following the intervention?\n\nDoes the intervention impact clinical outcomes such as hospital readmissions, functional independence, or mortality over the following 12 months?\n\nResearchers will compare two groups:\n\nOne group receiving the Vivifrail exercise program plus a daily dose of the anti-inflammatory nutritional supplement Alisenoc™.\n\nAnother group receiving the same Vivifrail program plus an isocaloric, protein-equivalent conventional supplement.\n\nParticipants will:\n\nBe aged 75 years or older and identified as frail and malnourished according to Fried and GLIM criteria.\n\nUndergo baseline evaluation including functional performance (SPPB), body composition via bioimpedance analysis, and blood sample collection for inflammatory biomarkers.\n\nBe randomly assigned to one of the two intervention groups.\n\nFollow a 12-week home-based multicomponent exercise program guided by educational materials and supervised remotely.\n\nConsume the assigned oral nutritional supplement daily for the same 12-week period.\n\nReturn for outcome assessments at 12 weeks, and again at 6 and 12 months for long-term follow-up.\n\nAll study procedures will take place at the Hospital Universitario de Navarra (HUN), Spain. Participants will be recruited from outpatient geriatrics and nutrition clinics and assessed at a dedicated research unit with nursing support. The intervention is designed to be feasible, scalable, and representative of real-world multidisciplinary care in older populations with high vulnerability.\n\nThe study aims to provide evidence for an integrative, personalized approach to reversing frailty through combined physical and nutritional strategies targeting the biological basis of inflammaging.",[65,66],"Frail Elderly Syndrome","Malnutrition Elderly",[68,69,70],"inflammaging","malnutrition","frailty","NOT_YET_RECRUITING","2025-09-11",{"date":74,"type":75},"2025-09-19","ACTUAL",{"date":77,"type":59},"2025-10-01",{"date":79,"type":59},"2027-10-01",{"name":5,"class":6}]