[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659932":3},{"organization":4,"outcomesModule":7,"designInfo":80,"detailedDescription":93,"studyPopulation":85,"armGroups":94,"interventions":107,"overallOfficials":85,"centralContacts":117,"locations":85,"responsibleParty":126,"collaborators":130,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":145,"sex":151,"minAge":152,"maxAge":85,"enrollmentInfo":153,"targetDuration":85,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":168,"whyStopped":85,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":85},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Change in exercise endurance time (constant work rate exercise test, CWRET)","Measured as the amount of time spent exercising at a constant intensity during a \"constant work rate\" cardiopulmonary exercise test. Intensity (constant work rate) will be determined for each individual using their baseline incremental cardiopulmonary exercise test.","Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)",[14,17,20,23,26,29,33,36,39,42],{"measure":15,"description":16,"timeFrame":12},"Proportion of 'responders' achieving the MCID change in exercise endurance time","Responder analyses based on the minimum clinically important difference (MCID) of +1 minute increase in exercise endurance time between baseline and following intervention.",{"measure":18,"description":19,"timeFrame":12},"Change in 6-minute walk distance (6MWD)","6MWD measured during a standard 6-minute walk test (6MWT).",{"measure":21,"description":22,"timeFrame":12},"Quadriceps strength","Change in quadriceps strength measured during an isometric maximum voluntary contraction on a seated dynamometer. Study site-specific assessment.",{"measure":24,"description":25,"timeFrame":12},"Change in St. George's Respiratory Questionnaire (SGRQ) score","SGRQ score is a patient-reported outcome that measures respiratory health-related quality of life. SGRQ score ranges from 0-100 where greater scores indicate worse health-related quality of life.",{"measure":27,"description":28,"timeFrame":12},"Change in COPD Assessment Test (CAT) score","The COPD Assessment Test (CAT) is a patient-reported outcome assessing COPD-specific symptom burden. CAT score ranges from 0-40 where higher scores indicate greater symptom burden.",{"measure":30,"description":31,"timeFrame":32},"Exercise training volume","Exercise training volume measured based on regularly recorded pulmonary rehabilitation (PR) program exercise training logs.","Measured per session and cumulatively as the total training volume during pulmonary rehabilitation (PR) participation.",{"measure":34,"description":35,"timeFrame":12},"Changes in perceptual responses during constant work rate cardiopulmonary exercise testing and at iso-time","Perceptual responses (symptom ratings) for breathlessness intensity and leg discomfort will be measured serially during constant work rate cardiopulmonary exercise testing using the 0-10 Borg scale. Iso-time means at the same time-point of sub-maximal exercise time (before end-exercise) completed at the shorter constant work rate cardiopulmonary exercise test by an individual.",{"measure":37,"description":38,"timeFrame":12},"Changes in physiological responses during constant work rate cardiopulmonary exercise testing and at iso-time","Physiological responses to exercise, including breathing pattern, gas exchange, and operating lung volumes, are measured continuously during cardiopulmonary exercise testing. Iso-time means at the same time-point of sub-maximal exercise time (before end-exercise) completed at the shorter constant work rate cardiopulmonary exercise test by an individual.",{"measure":40,"description":41,"timeFrame":12},"Changes in body composition","Changes in body composition (including fat-free mass, fat mass, and leg lean mass) will be measured using dual x-ray absorptiometry (DXA) scans. At specific study sites, body composition will also be measured using bioelectrical impedance assay (BIA).",{"measure":43,"description":44,"timeFrame":12},"Isokinetic cycling peak power output (PPO)","Isokinetic cycling peak power output (PPO) is measured during a ≤10-second cycling effort on a stationary isokinetic bicycle. Site-specific assessment.",[46,50,54,58,62,65,68,71,74,77],{"measure":47,"description":48,"timeFrame":49},"Adherence\u002FFidelity Outcome: Oral intervention adherence between groups","Total oral intervention adherence (percentage of completed doses) to the assigned intervention (Urolithin A or placebo).","8-week intervention period",{"measure":51,"description":52,"timeFrame":53},"Adherence\u002FFidelity Outcome: Urolithin A blood levels","Urolithin A blood levels will be compared between groups using a dried blood spot (DBS) sample.","Day 28±7 of the study intervention period",{"measure":55,"description":56,"timeFrame":57},"Safety Outcome: number and proportion of adverse events between groups","Adverse events (AEs) will be monitored from the signing of informed consent until end of study participation. All AEs will be treated as per standard of care and followed until resolution or end of study participation, and assessed by an independent data monitoring committee at pre-specified intervals.","Approximately 14 weeks",{"measure":59,"description":60,"timeFrame":61},"Exploratory Outcome: perceived assigned intervention","Participants will be asked, following the intervention period, which study intervention (Urolithin A or placebo) that they believe they received.","Following completion of 8-week intervention period",{"measure":63,"description":64,"timeFrame":12},"Exploratory Outcome: changes in mitochondrial function","Changes in mitochondrial function will be analyzed in permeabilized fresh muscle tissue using high-resolution respirometry. This measurement is study site-specific in a subgroup of participants only.",{"measure":66,"description":67,"timeFrame":12},"Exploratory Outcome: changes in muscle histology","Stains for mitochondrial markers (including succinate dehydrogenase) related to muscle histology will be analyzed post-intervention in comparison to pre-intervention. This measurement is study site-specific in a subgroup of participants only.",{"measure":69,"description":70,"timeFrame":12},"Exploratory Outcome: changes in mitochondrial proteins","Changes in mitochondrial proteins related to mitochondrial function will be measured using specific protein detection in targeted Western blot analyses. This measurement is study site-specific in a subgroup of participants only.",{"measure":72,"description":73,"timeFrame":12},"Exploratory Outcome: changes in mitochondrial morphology","Changes in mitochondrial morphology will be measured using transmission electron microscopy. This measurement is study site-specific in a subgroup of participants only.",{"measure":75,"description":76,"timeFrame":12},"Exploratory Outcome: Changes in the number of mitochondria","The number of mitochondria will be measured using transmission electron microscopy. This measurement is study site-specific in a subgroup of participants only.",{"measure":78,"description":79,"timeFrame":12},"Exploratory Outcome: mRNA transcript changes","Specific mRNA transcript changes related to mitochondrial function and whole transcriptome post-intervention in comparison to pre-intervention using bulk RNA-sequencing. This measurement is study site-specific in a subgroup of participants only.",{"allocation":81,"interventionModel":82,"interventionModelDescription":83,"primaryPurpose":84,"observationalModel":85,"timePerspective":85,"maskingInfo":86},"RANDOMIZED","PARALLEL","Adaptive RCT design element: At the 50% recruitment milestone, the sample size will be re-calculated by an external statistician, and the anticipated number of participants to be enrolled may be updated accordingly.","TREATMENT",null,{"masking":87,"maskingDescription":85,"whoMasked":88},"QUADRUPLE",[89,90,91,92],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Pulmonary rehabilitation is a central standard of care intervention for chronic disease management in patients with COPD.\n\nUrolithin A is a natural health product found in berries, pomegranates, and nuts. Urolithin A is approved by the FDA and Health Canada, but no study to date has investigated whether taking Urolithin A improves outcomes in patients with COPD. In previous studies in people without COPD, Urolithin A has been found to stimulate the cellular process known as mitophagy, improving the function of mitochondria, as well as functional capacity. In patients with COPD, it is therefore possible that Urolithin A may lead to improved exercise capacity and muscle strength.\n\nUrolithin A, in combination with pulmonary rehabilitation, may lead to a greater benefit in patients with COPD in terms of exercise capacity and other important health outcomes than pulmonary rehabilitation alone.\n\nPatients with COPD participating in a standard pulmonary rehabilitation program are being recruited for this study. Study participants will be randomly assigned and provided either with Urolithin A or with a visually identical placebo, to be taken every day during the 8-week pulmonary rehabilitation program. Study outcomes will then be compared between the Urolithin A group and the placebo group.",[95,101],{"label":96,"type":97,"description":98,"interventionNames":99},"Urolithin A + PR","EXPERIMENTAL","8-week daily oral dose of 1000 mg Urolithin A initiated at the start of pulmonary rehabilitation (PR)",[100],"Dietary Supplement: Urolithin A",{"label":102,"type":103,"description":104,"interventionNames":105},"Placebo + PR","PLACEBO_COMPARATOR","8 week daily oral dose of visually identical placebo pills initiated at the start of pulmonary rehabilitation (PR)",[106],"Other: Placebo",[108,113],{"type":109,"name":110,"description":111,"armGroupLabels":112,"otherNames":85},"DIETARY_SUPPLEMENT","Urolithin A","Urolithin A is a post-biotic compound naturally found in foods like berries, pomegranates, and nuts. Due to inter-individual differences in digestion and metabolism, the most effective way to reliably increase Urolithin A levels in humans is through direct supplementation of Urolithin A. Urolithin A has been found to directly activate the cellular process known as mitophagy.",[96],{"type":6,"name":114,"description":115,"armGroupLabels":116,"otherNames":85},"Placebo","Placebo pills visually identical to Urolithin A pills will be used as the placebo in this trial.",[102],[118,123],{"name":119,"role":120,"phone":121,"phoneExt":85,"email":122},"Bryan A. Ross, MD, MSc (Physiol.), MSc (Epi.)","CONTACT","5148431465","bryan.ross@mcgill.ca",{"name":124,"role":120,"phone":121,"phoneExt":85,"email":125},"Dan A. Nguyen, PhD(c)","dan.nguyen2@mail.mcgill.ca",{"type":127,"investigatorFullName":128,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":85,"oldOrganization":85},"SPONSOR_INVESTIGATOR","Bryan A. Ross","MD, MSc (Physiol.), MSc (Epi.)",[131,134,137,138,141],{"name":132,"class":133},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":135,"class":136},"Amazentis SA","INDUSTRY",{"name":5,"class":6},{"name":139,"class":140},"Jewish General Hospital (Montreal, Quebec, Canada)","UNKNOWN",{"name":142,"class":6},"Ottawa Hospital Research Institute","100659932","phase-2-urolithin-a-supplementation-during-pulmonary-rehabilitation-in-patients-with-copd-100659932",false,"NCT07871357","Urolithin A Supplementation During Pulmonary Rehabilitation in Patients With COPD","The Supplementation With Urolithin A During Pulmonary Rehabilitation in COPD (SUPRA-COPD) Trial","SUPRA-COPD","Inclusion Criteria:\n\n1. Males and females, aged \\>40, former smokers with ≥10 pack-year smoking history\n2. Post-bronchodilator FEV1\u002FFVC \\\u003C 0.7, with FEV1 \\\u003C 80% (moderate, 'GOLD 2') FEV1 \\\u003C 50% (severe, 'GOLD 3') or FEV1 \\\u003C 30% (very severe, 'GOLD 4') COPD\n3. Baseline 6MWD of ≥50m\n\nExclusion Criteria:\n\n1. Inability to participate in a standard PR program\n2. Severe\u002Funstable cardiac disease, neurological or orthopedic conditions which could hinder exercise performance\n3. Inability to provide consent due to language or cognitive barrier\n4. Previous 7-8-week PR participation in the last 6 months, or in a study involving an exercise program in the last 6 months\n5. Experienced an exacerbation of COPD (ECOPD) within the prior 4 weeks\n6. Long-term oxygen therapy use, or maintenance oral corticosteroid use (\\>5 mg daily)\n7. Presence of pacemaker or implantable cardioverter defibrillator (ICD) (unless participant opts out of bioelectrical impedance assay)\n8. Unwilling to agree to refrain from using, or are found to be using, the following supplementary antioxidant vitamins from 7 days prior to dosing and throughout the treatment period: Coenzyme Q10, resveratrol, and L-carnitine\n9. Unwilling to agree to refrain from using, or are found to be using, the following dietary restrictions from 7 days prior to dosing and throughout the treatment period: pomegranate juice, walnuts, pecans, strawberries, raspberries, and blackberries\n10. Allergy to lecithin, to soy or to sunflower\n11. Pregnant, breastfeeding or planning to become pregnant\n\n    The following exclusion criteria apply only for participants who additionally consent to an optional muscle biopsy (only being performed at specific study sites):\n12. Any condition, including but not limited to, the use of anticoagulant, presence of a clotting disorder, allergy to anesthetics such as xylocaine and lidocaine, that is not stable in the opinion of the investigator that could affect the safety of the patient in the study (if participating in muscle biopsy group).\n13. Chronic myalgia, fibromyalgia or conditions characterized by regular muscle pain (if participating in muscle biopsy subgroup)\n14. Metal fixation plates or screws in the legs from a previous surgery (if participating in muscle biopsy subgroup)","ALL","40 Years",{"count":154,"type":155},198,"ESTIMATED","INTERVENTIONAL",[158],"PHASE2","SUPRA-COPD is a multicenter triple-blind, parallel arm, placebo-controlled randomized controlled trial investigating the efficacy and safety of Urolithin A supplementation during pulmonary rehabilitation in patients with COPD.\n\nThe goal of the SUPRA-COPD study is to investigate whether Urolithin A supplementation during pulmonary rehabilitation in patients with COPD improves exercise tolerance, along with several other clinically important outcomes, above and beyond pulmonary rehabilitation participation alone.\n\nStudy participation will be approximately 14 weeks and involves in-person visits evaluating exercise tolerance before and after PR.",[161],"Chronic Obstructive Pulmonary Disease (COPD)",[163,110,164,165,166,167],"pulmonary rehabilitation","COPD","exercise tolerance","mitophagy","constant work rate exercise test (CWRET)","NOT_YET_RECRUITING","2026-10-04",{"date":171,"type":172},"2026-10-13","ACTUAL",{"date":174,"type":155},"2026-11",{"date":176,"type":155},"2029-12",{"name":128,"class":6}]