{"type":"trials","record":{"id":90727,"source_id":"clinicaltrials-gov","external_id":"NCT01404195","title":"Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia","brief_summary":"1. RATIONALE The unique characteristic of our study lies in the attempt to reverse the functional impairment experienced by sarcopenic patients with hip fracture using nutritional intervention. What makes this study different from prior studies is that it will be conducted in a hospital setting, unlike most prior studies, which were conducted in a community setting. The association between muscle mass and strength, inflammatory indices, and functional impairment versus dependence and fragility will also be measured. 2. HYPOTHESIS The hypothesis of our study is that nutritional intervention enriched in metabolites of essential amino acids (beta-hydroxy-beta-methylbutyrate) is effective for treating sarcopenia in elderly patients with hip fracture and improves functional level. 3. OBJECTIVES Primary objective is to assess functional improvement after nutritional intervention in sarcopenic patients with hip fracture, as measured using Barthel index. Secondary objectives will include: 1) to show the relationship between metabolic and inflammatory indices and sarcopenia; 2) to show how sarcopenia and its treatment influence the risk of fall; 3) to show muscle mass improvement; 4) to show increased strength; 5) to assess mortality and morbidity. 4. EXPECTED RESULTS The investigators expect to find that the supplemented group experiences throughout the study period a significant improvement in functional status (Barthel index), an increase in muscle mass, and a reduction in fat mass. An increased strength and a reduction in associated complications (falls) are also expected. The investigators hope to be able to show reductions in inflammatory indices and insulin resistance. To conclude, by improving muscle strength and mass the investigators expect to find a reduction in the disability and dependence of this population group.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Hospital Viamed Valvanera, Spain","enrollment":110,"countries":["Spain"],"start_date":"2012-01-01","completion_date":"2015-12-01","last_update_date":"2016-02-05","source_url":"https://clinicaltrials.gov/study/NCT01404195","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T04:15:35.799123+00:00","last_seen_at":"2026-09-25T04:15:35.417+00:00","metadata":{"sex":"ALL","acronym":"HIPERPROT","age_range":"65 Years","comparator":"Control","organization":"Hospital Viamed Valvanera, Spain","interventions":["Ensure Plus Advance"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change from baseline in Barthel index — On admission to hospital and at discharge.","Change from baseline in bioelectrical impedance analysis — On admission to hospital and at discharge.","Change from baseline in strength will be measured in the dominant hand using a portable JAMAR dynamometer — On admissio…","Death for any cause — During admission","Univariate analysis of the relationship between levels of IL-1, IL-6 and TNF-alpha and values of bioelectrical impedanc…","Prevalence of sarcopenia — hospital admission"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Sarcopenia","Hip Fracture","Ensure Plus Advance"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":35,"publication_state":"published","match_explanation":"Title contains controlled term: sarcopenia.","quality_checked_at":"2026-09-25T04:15:37.666886+00:00","duplicate_cluster_key":"id:nct01404195","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2012-01-01 to 2015-12-01","comparator":"Control","confidence":"structured-source","population":"ALL · 65 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T04:15:35.440Z","intervention":["Ensure Plus Advance"],"participants":110,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Change from baseline in Barthel index — On admission to hospital and at discharge.","Change from baseline in bioelectrical impedance analysis — On admission to hospital and at discharge.","Change from baseline in strength will be measured in the dominant hand using a portable JAMAR dynamometer — On admissio…","Death for any cause — During admission","Univariate analysis of the relationship between levels of IL-1, IL-6 and TNF-alpha and values of bioelectrical impedanc…","Prevalence of sarcopenia — hospital admission"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"sarcopenia","is_published":true,"match_reasons":["Title contains controlled term: sarcopenia.","Abstract contains controlled term: sarcopenia.","Source terminology contains: sarcopenia.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sarcopenia","slug":"sarcopenia"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/90727","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}