CopdPhase 2NCT06324214
Oral Supplementation During PR Participation in COPD
A Phase 2 study testing Urolithin A (Mitopure) in people with Copd, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a very common and chronic lung condition and is a leading cause of morbidity and death. These patients have persistent breathlessness and exercise intolerance, affecting their ability to carry out routine daily tasks. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd
- What is being tested?
- Urolithin A (Mitopure)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 3 sitesCanada
- Study dates
- 11 Mar 2024to 29 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, aged >40, former smokers with ≥10 pack-year smoking history
- Post-bronchodilator forced expiratory volume at one second (FEV1) / forced vital capacity (FVC) ratio < 0.7, with FEV1 < 80% (moderate, Global Initiative for Chronic Obstructive Lung Disease '(GOLD) 2') FEV1 < 50% (severe, 'GOLD 3') or FEV1 < 30% (very severe, 'GOLD 4') COPD
- Baseline 6MWD of ≥50m
Who cannot join
- Inability to participate in a standard PR program
- Severe/unstable cardiac disease, neurological or orthopedic conditions which could hinder exercise performance
- Inability to provide consent due to language or cognitive barrier
- Previous PR participation in the last 12 months, or in a study involving an exercise program in the last 6 months
- Experienced an exacerbation of COPD (ECOPD) within the prior 4 weeks
- Long-term oxygen therapy use, or maintenance oral corticosteroid use
Show all 14Show fewer
- Presence of pacemaker or implantable cardioverter defibrillator (ICD) (unless participant opts out of bioelectrical impedance assay)
- 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
- 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
- Allergy to lecithin, to soy or to sunflower
- Pregnant, breastfeeding or planning to become pregnant
- 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).
- Chronic myalgia, fibromyalgia or conditions characterized by regular muscle pain (if participating in muscle biopsy subgroup)
- Metal fixation plates or screws in the legs from a previous surgery (if participating in muscle biopsy subgroup)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Centre d'Expertise en Maladies Chroniques (CEMC)
Longueuil, Quebec
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Mount Sinai Hospital
Montreal, Quebec
About this study
Official title: Urolithin A Supplementation During Pulmonary Rehabilitation Participation in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Pilot and Feasibility Study
Chronic obstructive pulmonary disease (COPD) is a very common and chronic lung condition and is a leading cause of morbidity and death. These patients have persistent breathlessness and exercise intolerance, affecting their ability to carry out routine daily tasks. Standard COPD treatments include medicines/puffers as well as participation in a Pulmonary Rehabilitation (PR) program. PR programs are delivered by a diverse team of healthcare experts in exercise and nutrition. It is possible that an emerging nutritional oral supplement could target the muscular dysfunction seen in patients with COPD in part by promoting better working mitochondria, the energy 'engine' of muscle. A series of recently published studies in sedentary adults and in older adults have demonstrated the safety, tolerability, and potential clinical effectiveness of this supplement.
In this regard, the investigators plan to lead a large randomized controlled trial (RCT) to test whether oral supplementation in patients with COPD who are also participating in a standard PR program will improve overall exercise performance. The investigators will also test muscle strength, cognition, body composition, and other clinically important outcomes such as quality of life. Lastly, the investigators will use muscle tissue from a subgroup of volunteers to investigate the effect on muscle/mitochondrial structure/function.
The focus is actually the critical 'first step' before the larger RCT: a pilot and feasibility study on a smaller number of participants with COPD, as an important proof-of-concept that the larger study can, and should, be conducted.
Read the detailed description
The main objectives for this pilot feasibility study are to document recruitment rates, collect information on participant acceptability of tests, establish the capacity to run the RCT at our site, to demonstrate successful molecular testing of specimens, and to generate pilot data for the outcomes being tested in the larger subsequent RCT.
The overarching goal for the 'larger', future project will be to determine the effect of the oral supplement on exercise capacity, muscle strength, mitochondrial function, health-related quality of life, cognition, symptom burden, and safety/adherence in patients with COPD who are participating in a Pulmonary Rehabilitation program. The goal of the present research project is to complete a pilot and feasibility study testing the same clinical outcomes on a smaller sample of eligible study participants during which participants receive the intervention for 8 weeks.
The primary objective is to determine whether administration of the oral supplement during participation in a standard multi-week in-person Pulmonary Rehabilitation (PR) program is associated with an improvement in exercise endurance capacity in patients with COPD, compared with PR participation and placebo supplementation.
The secondary objectives are to determine the effect of the oral supplement on i) global conditioning and exercise capacity; ii) muscle strength; iii) mitochondrial function; iv) body composition; v) quality of life and burden of disease; vi) cognition; vii) adverse events/complications and adherence, and viii) blood levels of Urolithin A.
We hypothesize that patients with COPD receiving oral supplementation during PR participation will demonstrate an improvement in Constant Work Rate Exercise Test (CRWET) time after 8 weeks when compared to patients with COPD who receive placebo and PR participation.
- Conditions
- Copd
- Being tested
- Urolithin A (Mitopure), Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urolithin A (Mitopure)Dietary supplement
Compound belonging to the 'urolithin' class. First discovered over 40 years ago as a gut-derived metabolite in rats and subsequently in humans. A food and dietary ingredient, and more specifically, a post-biotic compound. Derived from ellagitannins, which are present in foods such as pomegranate, berries, and walnuts. An 'inducer' of mitophagy.
PlaceboOther
Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Participants will participate in a standard PR program and will receive placebo. Receives: Other: Placebo |
| Intervention (Urolithin A: Mitopure) Group | Active comparator | Participants will participate in a standard PR program and will receive the oral supplement. Receives: Dietary Supplement: Urolithin A (Mitopure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Feasibility Outcome: Recruitment rate
The proportion of participants who agree to participate out of the number of all potential participants asked to participate.
Recruitment rate represents the primary feasibility outcome of the current pilot RCT.
Measured: From study launch to study completion at every visit until post-intervention visit (average week 14)
Constant Work Rate Exercise Test (CWRET)
Exercise test whereby the workload is constant and is calculated as a percentage of the peak power output observed in the incremental test.
CWRET time represents the pre-specified primary outcome of the planned main RCT.
Measured: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Secondary outcomes (14)
Feasibility Outcome: Attrition rate
The percentage of participants who do not complete the study out of all participants randomized.
Outcome of the current pilot RCT.
Measured: From study launch to study completion at every visit until post-intervention visit (average week 14)
Adherence/Fidelity Outcome: Differences in dosed missed
The total number of doses missed will be recorded and reported. Outcome of the current pilot RCT.
Measured: 8 weeks
Feasibility Outcome: Study test completion rate
Study test completion rate of each assessment (percentage of participants who complete each assessment).
Outcome of the current pilot RCT.
Measured: From study launch to study completion at every visit until post-intervention visit (average week 14)
Safety Outcome: Adverse events
Adverse events (AEs) will be monitored from the signing of the Informed Consent Form (ICF) through completion of study participation. If any AEs do occur, study participants will be followed until symptoms have resolved or have returned to baseline levels. All outstanding AEs will be followed until resolution or until the participant's last study visit.
Measured: 14 weeks
6-Minute Walk Test (6MWT)
6-Minute Walk Distance (6MWD) obtained on a standard 6MWT.
Measured: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Quadriceps strength
4-second maximum quadriceps strength test.
Measured: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Disease-specific impact on quality of life
St. George's respiratory questionnaire (SGRQ) score is a patient reported outcome measuring quality of life from 0-100 where higher scores indicate worse quality of life.
Measured: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Burden of disease
COPD assessment test (CAT) scores is a patient reported outcome measuring COPD symptom burden from 0-40 where higher scores indicate worse symptom burden.
Measured: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Body composition
Dual X-ray absorptiometry (DXA) scan
Measured: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Body impedance
Bioelectrical impedance assay (BIA)
Measured: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Isokinetic cycling peak power output (PPO)
Isokinetic cycling PPO is measured during a ≤10-second cycling effort on a stationary isokinetic bicycle.
Measured: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Cognition
Stroop test
Measured: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Adherence/Fidelity Outcome: Blood levels of the intervention
Blood levels of Urolithin A will be collected at the mid-point of the study.
Measured: Day 28
Feasibility Outcome: Muscle biopsy volunteer rate
Proportion of participants who consent to the optional muscle biopsy out of those who also meet eligibility criteria for the optional muscle biopsy.
Measured: From study launch to study completion at every visit until post-intervention visit (average week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start11 Mar 2024
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Amazentis SA
- Responsible party
- Principal investigator, Bryan A. Ross, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324214
- Sponsor's protocol ID
- 2023-9352
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data privacy regulations, individual participant data collected during this study is not publicly accessible. However, access to anonymized data may be granted upon evaluation by the trial management group. Additional documents will also be available upon inquiry. All requests should be directed to the Principal Investigator (BAR).
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urolithin A Supplementation During Pulmonary Rehabilitation Participation in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT06324214
- Acronym / sponsor ID
- 2023-9352
- Conditions
- Copd
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Amazentis SA
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) is a very common and chronic lung condition and is a leading cause of morbidity and death. These patients have persistent breathlessness and exercise intolerance, affecting their ability to carry out routine daily tasks. Standard COPD treatments include medicines/puffers as well as participation in a Pulmonary Rehabilitation (PR) program. PR programs are delivered by a diverse team of healthcare experts in exercise and nutrition. It is possible that an emerging nutritional oral supplement could target the muscular dysfunction seen in patients with COPD in part by promoting better working mitochondria, the energy 'engine' of muscle. A series of recently published studies in sedentary adults and in older adults have demonstrated the safety, tolerability, and potential clinical effectiveness of this supplement.
In this regard, the investigators plan to lead a large randomized controlled trial (RCT) to test whether oral supplementation in patients with COPD who are also participating in a standard PR program will improve overall exercise performance. The investigators will also test muscle strength, cognition, body composition, and other clinically important outcomes such as quality of life. Lastly, the investigators will use muscle tissue from a subgroup of volunteers to investigate the effect on muscle/mitochondrial structure/function.
The focus is actually the critical 'first step' before the larger RCT: a pilot and feasibility study on a smaller number of participants with COPD, as an important proof-of-concept that the larger study can, and should, be conducted.
Detailed description
The main objectives for this pilot feasibility study are to document recruitment rates, collect information on participant acceptability of tests, establish the capacity to run the RCT at our site, to demonstrate successful molecular testing of specimens, and to generate pilot data for the outcomes being tested in the larger subsequent RCT.
The overarching goal for the 'larger', future project will be to determine the effect of the oral supplement on exercise capacity, muscle strength, mitochondrial function, health-related quality of life, cognition, symptom burden, and safety/adherence in patients with COPD who are participating in a Pulmonary Rehabilitation program. The goal of the present research project is to complete a pilot and feasibility study testing the same clinical outcomes on a smaller sample of eligible study participants during which participants receive the intervention for 8 weeks.
The primary objective is to determine whether administration of the oral supplement during participation in a standard multi-week in-person Pulmonary Rehabilitation (PR) program is associated with an improvement in exercise endurance capacity in patients with COPD, compared with PR participation and placebo supplementation.
The secondary objectives are to determine the effect of the oral supplement on i) global conditioning and exercise capacity; ii) muscle strength; iii) mitochondrial function; iv) body composition; v) quality of life and burden of disease; vi) cognition; vii) adverse events/complications and adherence, and viii) blood levels of Urolithin A.
We hypothesize that patients with COPD receiving oral supplementation during PR participation will demonstrate an improvement in Constant Work Rate Exercise Test (CRWET) time after 8 weeks when compared to patients with COPD who receive placebo and PR participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: PlaceboParticipants will participate in a standard PR program and will receive placebo. |
| Intervention (Urolithin A: Mitopure) Group | Active comparator | Dietary Supplement: Urolithin A (Mitopure)Participants will participate in a standard PR program and will receive the oral supplement. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females, aged >40, former smokers with ≥10 pack-year smoking history
- Post-bronchodilator forced expiratory volume at one second (FEV1) / forced vital capacity (FVC) ratio < 0.7, with FEV1 < 80% (moderate, Global Initiative for Chronic Obstructive Lung Disease '(GOLD) 2') FEV1 < 50% (severe, 'GOLD 3') or FEV1 < 30% (very severe, 'GOLD 4') COPD
- Baseline 6MWD of ≥50m
Key exclusion criteria (14 listed)
- Inability to participate in a standard PR program
- Severe/unstable cardiac disease, neurological or orthopedic conditions which could hinder exercise performance
- Inability to provide consent due to language or cognitive barrier
- Previous PR participation in the last 12 months, or in a study involving an exercise program in the last 6 months
- Experienced an exacerbation of COPD (ECOPD) within the prior 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urolithin A (Mitopure)Compound belonging to the 'urolithin' class. First discovered over 40 years ago as a gut-derived metabolite in rats and subsequently in humans. A food and dietary ingredient, and more specifically, a post-biotic compound. Derived from ellagitannins, which are present in foods such as pomegranate, berries, and walnuts. An 'inducer' of mitophagy. | Dietary supplement | Intervention (Urolithin A: Mitopure) Group |
| PlaceboPlacebo. | Other | Placebo Group |
Primary outcome
Primary Feasibility Outcome: Recruitment rate
Time frame: From study launch to study completion at every visit until post-intervention visit (average week 14)
The proportion of participants who agree to participate out of the number of all potential participants asked to participate. Recruitment rate represents the primary feasibility outcome of the current pilot RCT.
Constant Work Rate Exercise Test (CWRET)
Time frame: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Exercise test whereby the workload is constant and is calculated as a percentage of the peak power output observed in the incremental test. CWRET time represents the pre-specified primary outcome of the planned main RCT.
14 secondary outcomes
Feasibility Outcome: Attrition rate
Time frame: From study launch to study completion at every visit until post-intervention visit (average week 14)
Adherence/Fidelity Outcome: Differences in dosed missed
Time frame: 8 weeks
Feasibility Outcome: Study test completion rate
Time frame: From study launch to study completion at every visit until post-intervention visit (average week 14)
Safety Outcome: Adverse events
Time frame: 14 weeks
6-Minute Walk Test (6MWT)
Time frame: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Quadriceps strength
Time frame: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Disease-specific impact on quality of life
Time frame: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Burden of disease
Time frame: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Body composition
Time frame: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Body impedance
Time frame: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Isokinetic cycling peak power output (PPO)
Time frame: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Cognition
Time frame: Pre-intervention (baseline) and Post-intervention (after 8 weeks)
Adherence/Fidelity Outcome: Blood levels of the intervention
Time frame: Day 28
Feasibility Outcome: Muscle biopsy volunteer rate
Time frame: From study launch to study completion at every visit until post-intervention visit (average week 14)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Due to data privacy regulations, individual participant data collected during this study is not publicly accessible. However, access to anonymized data may be granted upon evaluation by the trial management group. Additional documents will also be available upon inquiry. All requests should be directed to the Principal Investigator (BAR).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Urolithin A (Mitopure) in people with Copd, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Feasibility Outcome: Recruitment rate (time frame: From study launch to study completion at every visit until post-intervention visit (average week 14)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 4 Nov 2026.