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COMPLETED

NCT06324214

PHASE2

Oral Supplementation During PR Participation in COPD

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-03-11

Completion Date

2026-07-29

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Copd

Interventions

DIETARY_SUPPLEMENT

Urolithin A (Mitopure)

Compound belonging to the 'urolithin' class. First discovered over 40 years ago as a gut-derived metabolite in rats and subsequently in humans. A food and dietary ingredient, and more specifically, a post-biotic compound. Derived from ellagitannins, which are present in foods such as pomegranate, berries, and walnuts. An 'inducer' of mitophagy.

OTHER

Placebo

Placebo.

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 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. 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)

Locations (3)

Centre d'Expertise en Maladies Chroniques (CEMC)

Longueuil, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Mount Sinai Hospital