A Phase 2 interventional study of Urolithin A and Placebo in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Bryan A. Ross. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Bryan A. Ross · Phase 2, Interventional, and Treatment
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.
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 198 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →This is the only study on the registry with Bryan A. Ross as lead sponsor.
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Exclusion Criteria:
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):
8-week daily oral dose of 1000 mg Urolithin A initiated at the start of pulmonary rehabilitation (PR)
Dietary Supplement: Urolithin A
8 week daily oral dose of visually identical placebo pills initiated at the start of pulmonary rehabilitation (PR)
Other: Placebo
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.
Placebo pills visually identical to Urolithin A pills will be used as the placebo in this trial.
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.
Time frame: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
Adherence/Fidelity Outcome: Oral intervention adherence between groups
Total oral intervention adherence (percentage of completed doses) to the assigned intervention (Urolithin A or placebo).
Time frame: 8-week intervention period
Adherence/Fidelity Outcome: Urolithin A blood levels
Urolithin A blood levels will be compared between groups using a dried blood spot (DBS) sample.
Time frame: Day 28±7 of the study intervention period
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.
Time frame: Approximately 14 weeks
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.
Time frame: Following completion of 8-week intervention period
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.
Time frame: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Time frame: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Time frame: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Time frame: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Time frame: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
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.
Time frame: Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)
No study locations are listed for this record.
Plan to share: 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).
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.
Of 42 non-industry phase 2 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 63. This study's planned 37 months is close to that.
Counting every sponsor, half of 138 studies reached it within 17 months; a quarter within 10 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Urolithin A
Pulmonary Disease, Chronic Obstructive →