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NOT YET RECRUITING

NCT07871357

PHASE2

Urolithin A Supplementation During Pulmonary Rehabilitation in Patients With COPD

Sponsor: Bryan A. Ross

View on ClinicalTrials.gov

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.

Official title: The Supplementation With Urolithin A During Pulmonary Rehabilitation in COPD (SUPRA-COPD) Trial

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

198

Start Date

2026-11

Completion Date

2029-12

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

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.

OTHER

Placebo

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

Inclusion Criteria: 1. Males and females, aged \>40, former smokers with ≥10 pack-year smoking history 2. 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 3. Baseline 6MWD of ≥50m Exclusion Criteria: 1. Inability to participate in a standard PR program 2. Severe/unstable cardiac disease, neurological or orthopedic conditions which could hinder exercise performance 3. Inability to provide consent due to language or cognitive barrier 4. Previous 7-8-week PR participation in the last 6 months, or in a study involving an exercise program in the last 6 months 5. Experienced an exacerbation of COPD (ECOPD) within the prior 4 weeks 6. Long-term oxygen therapy use, or maintenance oral corticosteroid use (\>5 mg daily) 7. Presence of pacemaker or implantable cardioverter defibrillator (ICD) (unless participant opts out of bioelectrical impedance assay) 8. 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 9. 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 10. Allergy to lecithin, to soy or to sunflower 11. 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): 12. 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). 13. Chronic myalgia, fibromyalgia or conditions characterized by regular muscle pain (if participating in muscle biopsy subgroup) 14. Metal fixation plates or screws in the legs from a previous surgery (if participating in muscle biopsy subgroup)