Oral supplementation during pulmonary rehabilitation for COPD patients

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

This study is testing if an oral nutritional supplement can help people with COPD improve their exercise endurance and overall well-being while they participate in a Pulmonary Rehabilitation program.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (Academic / other)
• Locations: 1 site (Montréal, Quebec)
• Trial ID: NCT06324214 on ClinicalTrials.gov

What this trial studies

This pilot feasibility study aims to evaluate the effects of an oral nutritional supplement, Urolithin A (Mitopure), on patients with chronic obstructive pulmonary disease (COPD) participating in a Pulmonary Rehabilitation (PR) program. The study will assess recruitment rates, participant acceptability, and the capacity to conduct a larger randomized controlled trial (RCT). Participants will receive the supplement for 8 weeks, and the primary objective is to determine its impact on exercise endurance capacity compared to a placebo. Secondary objectives include evaluating muscle strength, mitochondrial function, quality of life, and cognition.

Who should consider this trial

Good fit: Ideal candidates are males and females over 40 years old, former smokers with moderate to very severe COPD, and who have completed at least two doses of the COVID-19 vaccine.

Not a fit: Patients unable to participate in a standard PR program or with severe/unstable cardiac or neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance exercise capacity and overall quality of life for COPD patients undergoing rehabilitation.

How similar studies have performed: Previous studies have shown the safety and potential effectiveness of similar nutritional supplements in improving health outcomes in sedentary and older adults.

Eligibility criteria

Inclusion Criteria:

1. Males and females, aged \>40, former smokers with ≥10 pack-year smoking history
2. 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
3. Baseline 6MWD of ≥50m
4. Prior receipt of at least 2 doses of the Coronavirus Disease of 2019 (COVID-19) vaccine

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 PR participation in the last 12 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
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
12. Use of anticoagulant or presence of a clotting disorder (if participating in muscle biopsy subgroup)
13. Allergy to anesthetics such as xylocaine and lidocaine (if participating in muscle biopsy subgroup)
14. Chronic myalgia, fibromyalgia or conditions characterized by regular muscle pain (if participating in muscle biopsy subgroup)
15. Metal fixation plates or screws in the legs from a previous surgery (if participating in muscle biopsy subgroup)

Where this trial is running

Montréal, Quebec

• McGill University Health Centre — Montréal, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Bryan Ross, MD, FRCPC, MSc (Epi, Physiol)

Conditions Copd