{"type":"trials","record":{"id":21877,"source_id":"clinicaltrials-gov","external_id":"NCT06556706","title":"Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults","brief_summary":"The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of Mitopure (Urolithin A) supplementation on muscle mitochondrial quality in frail older adults after 8-weeks of supplementation","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Amazentis SA","enrollment":26,"countries":["Canada"],"start_date":"2024-08-15","completion_date":"2025-04-25","last_update_date":"2025-05-28","source_url":"https://clinicaltrials.gov/study/NCT06556706","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":"2026-09-24T01:17:11.779627+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":"MitoEM","age_range":"65 Years to 85 Years","comparator":"Placebo; Mitopure (Urolithin A)","organization":"Amazentis SA","interventions":["Mitopure (Urolithin A)","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy — 8-weeks","Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy — 8-…","change between groups on the following: maximal mitochondrial O2 consumption assessed via via respirometry on permeabil…","change between groups in mitochondrial calcium retention capacity measured by mitochondrial permeability transition por…","mitochondrial DNA (mtDNA) over nuclear DNA ratio (mtDNA/nDNA) via qPCR — 8-weeks","Changes in body composition via Dual X-ray Absorptiometry (DXA) scan of total and appendicular lean mass — 8-weeks","Changes in composition via Peripheral quantitative computed tomography (pQCT) of muscle tissue — 8-weeks","Changes in the timed up and go test (time needed to stand from an armchair, walk a distance of 3 meters, turn around an…","Changes in grip strength measured by a hand dynamometer — 8-weeks","Changes in Berg balance test: Participant will be asked to maintain a given position or perform a task — 8-weeks","Changes in distance walked during the six-minute walk test — 8-weeks","Changes in the 30-second stand test: Participant will stand as many times as s/he can from a seated position for 30-sec…","Changes in Four-square step test: To assess balance, participant will step over small sticks placed in an X on the floo…","Changes in Unipedal stance test (UPST): First a ball will be kicked to determine dominant leg, then participant will be…","Recording of adverse events — 8-weeks","Quantification of muscle fiber type (type I/II) via Myosin Heavy Chain immunolabeling — 8-weeks","Analysis of markers of neuromuscular junction integrity (NCAM biomarker staining) — 8-weeks","Changes in knee extension strength measured by a hand dynamometer — 8-weeks"],"design_description":"RANDOMIZED · PARALLEL · BASIC SCIENCE · QUADRUPLE","source_has_results":false},"controlled_terms":["Frailty","Sarcopenia","Aging","Muscle Atrophy","Mitopure (Urolithin A)","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: urolithin a.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct06556706","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-08-15 to 2025-04-25","comparator":"Placebo; Mitopure (Urolithin A)","confidence":"structured-source","population":"ALL · 65 Years to 85 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":"2026-09-25T06:10:25.823Z","intervention":["Mitopure (Urolithin A)","Placebo"],"participants":26,"study_design":"RANDOMIZED · PARALLEL · BASIC SCIENCE · 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":["Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy — 8-weeks","Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy — 8-…","change between groups on the following: maximal mitochondrial O2 consumption assessed via via respirometry on permeabil…","change between groups in mitochondrial calcium retention capacity measured by mitochondrial permeability transition por…","mitochondrial DNA (mtDNA) over nuclear DNA ratio (mtDNA/nDNA) via qPCR — 8-weeks","Changes in body composition via Dual X-ray Absorptiometry (DXA) scan of total and appendicular lean mass — 8-weeks","Changes in composition via Peripheral quantitative computed tomography (pQCT) of muscle tissue — 8-weeks","Changes in the timed up and go test (time needed to stand from an armchair, walk a distance of 3 meters, turn around an…","Changes in grip strength measured by a hand dynamometer — 8-weeks","Changes in Berg balance test: Participant will be asked to maintain a given position or perform a task — 8-weeks","Changes in distance walked during the six-minute walk test — 8-weeks","Changes in the 30-second stand test: Participant will stand as many times as s/he can from a seated position for 30-sec…","Changes in Four-square step test: To assess balance, participant will step over small sticks placed in an X on the floo…","Changes in Unipedal stance test (UPST): First a ball will be kicked to determine dominant leg, then participant will be…","Recording of adverse events — 8-weeks","Quantification of muscle fiber type (type I/II) via Myosin Heavy Chain immunolabeling — 8-weeks","Analysis of markers of neuromuscular junction integrity (NCAM biomarker staining) — 8-weeks","Changes in knee extension strength measured by a hand dynamometer — 8-weeks"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"urolithin-a","is_published":true,"match_reasons":["Title contains controlled term: urolithin a.","Abstract contains controlled term: urolithin a.","Source terminology contains: urolithin a.","Title supplies longevity context: frail, older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Urolithin A","slug":"urolithin-a"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/21877","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}