Urolithin A Supplementation During Pulmonary Rehabilitation in Patients With COPD

NCT07871357 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: 2026-12858553697
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

pulmonary rehabilitation; Urolithin A; COPD; exercise tolerance; mitophagy; constant work rate exercise test (CWRET)

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (10)

• Proportion of 'responders' achieving the MCID change in exercise endurance time

  Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)

• Change in 6-minute walk distance (6MWD)

  Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)

• Quadriceps strength

  Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)

• Change in St. George's Respiratory Questionnaire (SGRQ) score

  Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)

• Change in COPD Assessment Test (CAT) score

  Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)

Other Outcomes (10)

• Adherence/Fidelity Outcome: Oral intervention adherence between groups

  8-week intervention period

• Adherence/Fidelity Outcome: Urolithin A blood levels

  Day 28±7 of the study intervention period

• Safety Outcome: number and proportion of adverse events between groups

  Approximately 14 weeks

Study Arms (2)

Urolithin A + PR

EXPERIMENTAL

8-week daily oral dose of 1000 mg Urolithin A initiated at the start of pulmonary rehabilitation (PR)

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)

Other: Placebo

Interventions

Urolithin A DIETARY_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.

Urolithin A + PR

Placebo OTHER

Placebo pills visually identical to Urolithin A pills will be used as the placebo in this trial.

Placebo + PR

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Bryan A. Ross: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Amazentis SA: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Jewish General Hospital (Montreal, Quebec, Canada): collaborator
• Ottawa Hospital Research Institute: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bryan A. Ross, MD, MSc (Physiol.), MSc (Epi.)

CONTACT

5148431465; bryan.ross@mcgill.ca

Dan A. Nguyen, PhD(c)

CONTACT

5148431465; dan.nguyen2@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc (Physiol.), MSc (Epi.)

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2026
• First Posted: October 13, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 13, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share