{"type":"trials","record":{"id":22434,"source_id":"clinicaltrials-gov","external_id":"NCT07275996","title":"Neuromuscular and Multi-Omics Synergy of Combined Creatine × HMB Supplementation Plus Exercise to Improve Muscle Function in Sarcopenic Frailty","brief_summary":"Sarcopenia and physical frailty are highly prevalent among institutionalized older adults and are major contributors to functional decline, reduced mobility, and loss of independence. Combined exercise and targeted nutritional strategies have emerged as promising approaches to mitigate these age-related impairments. This randomized, double-blind, placebo-controlled, parallel-group clinical trial aims to evaluate the independent and combined effects of creatine monohydrate (CRE) and β-hydroxy-β-methylbutyrate (HMB), administered alongside a supervised multicomponent exercise program, on physical function, body composition, cognitive performance, and quality of life in institutionalized older adults with physical frailty and sarcopenia. A total of 50 adults aged ≥65 years were enrolled and randomized to one of four intervention groups for 12 weeks: placebo plus exercise, creatine plus exercise, HMB plus exercise, or creatine plus HMB plus exercise. A supplement-free follow-up period will be conducted to evaluate the sustainability of intervention effects. In addition to clinical and functional outcomes, the study incorporates molecular and biological assessments to explore mechanistic pathways underlying functional adaptation and interindividual variability in response to the interventions.","overall_status":"Active Not Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Universidad de Burgos","enrollment":50,"countries":["Spain"],"start_date":"2026-03-10","completion_date":"2027-05-30","last_update_date":"2026-05-04","source_url":"https://clinicaltrials.gov/study/NCT07275996","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T01:17:19.146275+00:00","last_seen_at":"2026-09-25T06:15:54.38+00:00","metadata":{"sex":"ALL","acronym":"MULTI-FRAIL","age_range":"65 Years","comparator":"Placebo + Exercise; Creatine + Exercise; HMB + Exercise","organization":"Universidad de Burgos","interventions":["Placebo (Cellulose)","Creatine Monohydrate","Multicomponent Exercise Program","β-Hydroxy-β-Methylbutyrate (HMB)"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Short Physical Performance Battery (SPPB) — Baseline, Week 12 (end of intervention), and 3-month follow-up","Timed Up and Go (TUG) — Baseline, Week 12 (end of intervention), and 3-month follow-up","Appendicular Lean Mass (ALM, kg) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Grip Strength — Baseline, Week 12 (end of intervention), and 3-month follow-up","Leg and Back Isometric Strength — Baseline, Week 12 (end of intervention), and 3-month follow-up","Seated Arm Curl Test — Baseline, Week 12 (end of intervention), and 3-month follow-up","Barthel Index — Baseline, Week 12 (end of intervention), and 3-month follow-up","Mini Nutritional Assessment (MNA) — Baseline, Week 12 (end of intervention), and 3-month follow-up","Cognitive Function - Mini-Mental State Examination (MMSE) — Baseline, Week 12 (end of intervention), and 3-month follow…","Quality of Life - World Health Organization Quality of Life-Brief (WHOQOL-BREF) — Baseline, Week 12 (end of interventio…","Total Lean Mass (kg) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Total Fat Mass (percent body weight) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Visceral Adipose Tissue (VAT, cm³) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Whole-Body Bone Mineral Density (BMD, g/cm²) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Cognitive Function - MEC (Spanish Adaptation of MMSE) — Baseline, Week 12 (end of intervention), and 3-month follow-up","Number of Falls — Baseline to 3-month follow-up","Number of Hospitalizations — Baseline to 3-month follow-up","Incidence of Respiratory and Urinary Infections — Baseline to 3-month follow-up","Incidence of Pressure Ulcers — Baseline to 3-month follow-up","Incidence of Urinary or Fecal Incontinence — Baseline to 3-month follow-up"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Frailty","Sarcopenia","Aging","Malnutrition Elderly","Placebo (Cellulose)","Creatine Monohydrate","Multicomponent Exercise Program","β-Hydroxy-β-Methylbutyrate (HMB)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: exercise.","quality_checked_at":"2026-09-25T06:16:07.48358+00:00","duplicate_cluster_key":"id:nct07275996","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-03-10 to 2027-05-30","comparator":"Placebo + Exercise; Creatine + Exercise; HMB + Exercise","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":"2026-09-25T06:15:54.410Z","intervention":["Placebo (Cellulose)","Creatine Monohydrate","Multicomponent Exercise Program","β-Hydroxy-β-Methylbutyrate (HMB)"],"participants":50,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","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":["Short Physical Performance Battery (SPPB) — Baseline, Week 12 (end of intervention), and 3-month follow-up","Timed Up and Go (TUG) — Baseline, Week 12 (end of intervention), and 3-month follow-up","Appendicular Lean Mass (ALM, kg) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Grip Strength — Baseline, Week 12 (end of intervention), and 3-month follow-up","Leg and Back Isometric Strength — Baseline, Week 12 (end of intervention), and 3-month follow-up","Seated Arm Curl Test — Baseline, Week 12 (end of intervention), and 3-month follow-up","Barthel Index — Baseline, Week 12 (end of intervention), and 3-month follow-up","Mini Nutritional Assessment (MNA) — Baseline, Week 12 (end of intervention), and 3-month follow-up","Cognitive Function - Mini-Mental State Examination (MMSE) — Baseline, Week 12 (end of intervention), and 3-month follow…","Quality of Life - World Health Organization Quality of Life-Brief (WHOQOL-BREF) — Baseline, Week 12 (end of interventio…","Total Lean Mass (kg) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Total Fat Mass (percent body weight) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Visceral Adipose Tissue (VAT, cm³) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Whole-Body Bone Mineral Density (BMD, g/cm²) by DEXA — Baseline, Week 12 (end of intervention), and 3-month follow-up","Cognitive Function - MEC (Spanish Adaptation of MMSE) — Baseline, Week 12 (end of intervention), and 3-month follow-up","Number of Falls — Baseline to 3-month follow-up","Number of Hospitalizations — Baseline to 3-month follow-up","Incidence of Respiratory and Urinary Infections — Baseline to 3-month follow-up","Incidence of Pressure Ulcers — Baseline to 3-month follow-up","Incidence of Urinary or Fecal Incontinence — Baseline to 3-month follow-up"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"exercise","is_published":true,"match_reasons":["Title contains controlled term: exercise.","Abstract contains controlled term: exercise.","Source terminology contains: exercise.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Exercise","slug":"exercise"}},{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/22434","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}