Urolithin A Supplementation During Pulmonary Rehabilitation in Patients With COPD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorBryan A. Ross
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Urolithin A
Dietary supplementUrolithin 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
Other interventionPlacebo pills visually identical to Urolithin A pills will be used as the placebo in this trial.
Treatment groups
198 Participants
are divided into 2 treatment groupsGroup A: Urolithin A + PRExperimental treatment 1 intervention
Group B: Placebo + PRPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Measured at baseline (before intervention + PR) and following intervention + PR (8 weeks)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
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 period2
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 period3
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 weeks4
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 periodLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bryan A. Ross
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor institution
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
Source ClinicalTrials.gov
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