Urolithin A Supplementation During Pulmonary Rehabilitation Participation in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Pilot and Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Chronic obstructive pulmonary disease (COPD) is a very common and chronic lung condition and is a leading cause of morbidity and death. These patients have persistent breathlessness and exercise intolerance, affecting their ability to carry out routine daily tasks. Standard COPD treatments include medicines/puffers as well as participation in a Pulmonary Rehabilitation (PR) program. PR programs are delivered by a diverse team of healthcare experts in exercise and nutrition. It is possible that an emerging nutritional oral supplement could target the muscular dysfunction seen in patients with COPD in part by promoting better working mitochondria, the energy 'engine' of muscle. A series of recently published studies in sedentary adults and in older adults have demonstrated the safety, tolerability, and potential clinical effectiveness of this supplement. In this regard, the investigators plan to lead a large randomized controlled trial (RCT) to test whether oral supplementation in patients with COPD who are also participating in a standard PR program will improve overall exercise performance. The investigators will also test muscle strength, cognition, body composition, and other clinically important outcomes such as quality of life. Lastly, the investigators will use muscle tissue from a subgroup of volunteers to investigate the effect on muscle/mitochondrial structure/function. The focus is actually the critical 'first step' before the larger RCT: a pilot and feasibility study on a smaller number of participants with COPD, as an important proof-of-concept that the larger study can, and should, be conducted.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Males and females, aged \>40, former smokers with ≥10 pack-year smoking history

• Post-bronchodilator forced expiratory volume at one second (FEV1) / forced vital capacity (FVC) ratio \< 0.7, with FEV1 \< 80% (moderate, Global Initiative for Chronic Obstructive Lung Disease '(GOLD) 2') FEV1 \< 50% (severe, 'GOLD 3') or FEV1 \< 30% (very severe, 'GOLD 4') COPD

• Baseline 6MWD of ≥50m

• Prior receipt of at least 2 doses of the Coronavirus Disease of 2019 (COVID-19) vaccine

Locations
Other Locations
Canada
McGill University Health Centre
RECRUITING
Montreal
Contact Information
Primary
Bryan Ross, MD, FRCPC, MSc (Epi, Physiol)
bryan.ross@mcgill.ca
(514) 843-1465
Time Frame
Start Date: 2024-03-11
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 10
Treatments
Placebo_comparator: Placebo Group
Participants will participate in a standard PR program and will receive placebo.
Active_comparator: Intervention (Urolithin A: Mitopure) Group
Participants will participate in a standard PR program and will receive the oral supplement.
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Amazentis SA

This content was sourced from clinicaltrials.gov