RecruitingPhase 2NCT06324214

Oral Supplementation During PR Participation in COPD

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

Sponsor

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

Enrollment

10 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

COPD

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

Min Age: 40 Years

Inclusion Criteria4

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

Exclusion Criteria15

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 PR participation in the last 12 months, or in a study involving an exercise program in the last 6 months
Experienced an exacerbation of COPD (ECOPD) within the prior 4 weeks
Long-term oxygen therapy use, or maintenance oral corticosteroid use
Presence of pacemaker or implantable cardioverter defibrillator (ICD) (unless participant opts out of bioelectrical impedance assay)
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
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
Allergy to lecithin, to soy or to sunflower
Pregnant, breastfeeding or planning to become pregnant
Use of anticoagulant or presence of a clotting disorder (if participating in muscle biopsy subgroup)
Allergy to anesthetics such as xylocaine and lidocaine (if participating in muscle biopsy subgroup)
Chronic myalgia, fibromyalgia or conditions characterized by regular muscle pain (if participating in muscle biopsy subgroup)
Metal fixation plates or screws in the legs from a previous surgery (if participating in muscle biopsy subgroup)

Interventions

DIETARY_SUPPLEMENTUrolithin 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.

OTHERPlacebo

Placebo.