{"type":"trials","record":{"id":22574,"source_id":"clinicaltrials-gov","external_id":"NCT04516421","title":"Protein Supplementation Intervention for Improving Muscle Mass and Physical Performance in Older People With Sarcopenia","brief_summary":"Background: Declines in muscle mass and strength are expected with aging, but physical inactivity and low protein intake have been suggested as risk factors of sarcopenia. So far, lifestyle interventions, especially exercise and nutritional supplementation, prevail as mainstays of treatment for sarcopenia. Objective: To explore the effect and benefits of protein supplementation on the improvement of muscle mass and physical performance in older people with sarcopenia. Design: A randomized, double-blind, placebo-controlled clinical trial. Methods: Participants aged 65-95y who meet the following criteria will be invited: (1) muscle mass: bioimpedance, \\<7.0 kg/m² (male) and \\<5.7 kg/m² (female), (2) handgrip strength: \\<28 kg (male) and \\<18 kg (female), and (3) low physical performance: 6-m gait Speed \\<1.0 m/s. Study participants will be randomly assigned to two groups. The experimental group will receive a 12-week intervention with【protein (14g)+ BCAA(4.4g)】 drink per day, while the parallel control group will receive a placebo oat drink per day. Participants in the control group will be asked to maintain participants' usual diet and physical activity. There are 3 time-points to measure outcomes and observe other required information, at week 0(baseline), 6 and 12.","overall_status":"Unknown","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Asia University","enrollment":80,"countries":["Taiwan"],"start_date":"2020-08-24","completion_date":"2022-06-30","last_update_date":"2022-02-14","source_url":"https://clinicaltrials.gov/study/NCT04516421","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Unknown. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-24T02:17:04.2999+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years to 95 Years","comparator":"Control (Placebo) group","organization":"Asia University","interventions":["Protein supplementation","Placebo oat drink"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Skeletal muscle mass index (\"change\" is being assessed) — The change is assessed from week 0 (baseline) to week 12","Hand-grip strength (\"change\" is being assessed) — The change is assessed from week 0 (baseline) to week 12","Gait speed (\"change\" is being assessed) — The change is assessed from week 0 (baseline) to week 12"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · DOUBLE","source_has_results":false},"controlled_terms":["Sarcopenia","Protein supplementation","Placebo oat drink"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: sarcopenia.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct04516421","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-08-24 to 2022-06-30","comparator":"Control (Placebo) group","confidence":"structured-source","population":"ALL · 65 Years to 95 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":"2026-09-25T06:10:25.873Z","intervention":["Protein supplementation","Placebo oat drink"],"participants":80,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · DOUBLE","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":["Skeletal muscle mass index (\"change\" is being assessed) — The change is assessed from week 0 (baseline) to week 12","Hand-grip strength (\"change\" is being assessed) — The change is assessed from week 0 (baseline) to week 12","Gait speed (\"change\" is being assessed) — The change is assessed from week 0 (baseline) to week 12"],"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: older people.","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/22574","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}