Oral Supplementation During PR Participation in COPD

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a new oral nutritional supplement can help improve exercise performance in patients with chronic obstructive pulmonary disease (COPD) who are also taking part in a standard Pulmonary Rehabilitation (PR) program. COPD is a long-term lung condition that makes it hard to breathe and can affect everyday activities. The trial aims to see if this supplement can strengthen muscles and enhance overall health, including muscle strength, cognitive function, body composition, and quality of life.

To be eligible for this study, participants must be over 40 years old, former smokers, and have a specific level of lung function (measured by a breathing test). They should also be able to walk a certain distance and have received at least two doses of a COVID-19 vaccine. Participants will be closely monitored throughout the trial, and there are some specific health conditions and medications that may prevent someone from joining. This study is an important first step before a larger trial can be conducted, and it will help researchers understand how effective the supplement can be for improving health in people with COPD.

Gender

ALL

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)