Chronic Obstructive Pulmonary Disease (COPD)Phase 2SUPRA-COPDNCT07871357
Urolithin A Supplementation During Pulmonary Rehabilitation in Patients With COPD
A Phase 2 study testing Urolithin A in people with Chronic Obstructive Pulmonary Disease (COPD), run by Bryan A. Ross.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Urolithin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2029
- Phase
- Phase 2
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 FEV1/FVC < 0.7, with FEV1 < 80% (moderate, '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 7-8-week PR participation in the last 6 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 (>5 mg daily)
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- 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
- The following exclusion criteria apply only for participants who additionally consent to an optional muscle biopsy (only being performed at specific study sites):
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Supplementation With Urolithin A During Pulmonary Rehabilitation in COPD (SUPRA-COPD) Trial
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.
The 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.
Study participation will be approximately 14 weeks and involves in-person visits evaluating exercise tolerance before and after PR.
Read the detailed description
Pulmonary rehabilitation is a central standard of care intervention for chronic disease management in patients with COPD.
Urolithin 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.
Urolithin 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.
Patients 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.
- Being tested
- Urolithin A, Placebo
- Keywords
- pulmonary rehabilitation, Urolithin A, COPD, exercise tolerance, mitophagy, constant work rate exercise test (CWRET)
- 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 ADietary supplement
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.
PlaceboOther
Placebo pills visually identical to Urolithin A pills will be used as the placebo in this trial.
| Study group | Role | What they receive |
|---|---|---|
| Urolithin A + PR | Experimental | 8-week daily oral dose of 1000 mg Urolithin A initiated at the start of pulmonary rehabilitation (PR) Receives: Dietary Supplement: Urolithin A |
| Placebo + PR | Placebo comparator | 8 week daily oral dose of visually identical placebo pills initiated at the start of pulmonary rehabilitation (PR) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
Secondary outcomes (10)
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.
Measured: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
Change in 6-minute walk distance (6MWD)
6MWD measured during a standard 6-minute walk test (6MWT).
Measured: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
Quadriceps strength
Change in quadriceps strength measured during an isometric maximum voluntary contraction on a seated dynamometer. Study site-specific assessment.
Measured: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Measured: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Measured: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
Exercise training volume
Exercise training volume measured based on regularly recorded pulmonary rehabilitation (PR) program exercise training logs.
Measured: Measured per session and cumulatively as the total training volume during pulmonary rehabilitation (PR) participation.
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.
Measured: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Measured: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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).
Measured: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Measured: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bryan A. Ross
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Amazentis SA, McGill University Health Centre/Research Institute of the McGill University Health Centre, Jewish General Hospital (Montreal, Quebec, Canada), Ottawa Hospital Research Institute
- Responsible party
- Sponsor-investigator, Bryan A. Ross, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871357
- Sponsor's protocol ID
- 2026-12858
- Other IDs
- 553697
- Acronym
- SUPRA-COPD
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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).