About this trial
Obesity and COPD are increasingly common and often coexist, worsening health outcomes such as reduced lung function, exercise capacity, and increased systemic inflammation. While COPD was historically associated with underweight, obesity is now more prevalent among these patients and poses new challenges. Despite some evidence that weight loss may improve lung function, comprehensive interventions have not been fully studied.
The TRIO-COPD study aims to evaluate a 20-week program combining energy restriction, adequate protein intake, and structured exercise in COPD patients with obesity. The study will assess:
Primary outcome:
-Exercise capacity (6-minute walking test).
Secondary outcomes:
-Lung function (spirometry and lung volumes), -symptoms ( assessed via questionnaires), body composition (fat mass, fat-free mass, waist circumference), and inflammatory markers (e.g., IL-6, CRP, CC16).
A subgroup will also undergo sputum analysis.
The study addresses a critical gap, aiming to determine whether structured weight reduction can improve COPD symptoms, reduce inflammation, and limit muscle loss-advancing understanding of obesity's impact on COPD and providing evidence for potential treatment guidelines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals with COPD, defined by the GOLD criteria, with a forced expiratory volume in one second (FEV1) < 80% of predicted and a forced expiratory ratio of <70, with a BMI ≥ 30 kg/m2
Disqualifiers
patients with untreated cardiac disease, renal or hepatic failure, active cancer treatment, diabetes mellitus with prescribed insulin or patients with reported unintentional weight loss in the previous three months, or physical impairment that might affect the exercise capacity.
Trial design
Sequential
Treatments tested in this trial
Energy restriction
Other interventionDiet with LED and energy restricted diet with gradually inclusion of meals
Treatment groups
Trial outcomes
Primary outcomes
6 minute walking test
Secondary outcomes
Lung function
FEV₁ (Forced Expiratory Volume in 1 second) FVC (Forced Vital Capacity) FEV₁/FVC ratio
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sahlgrenska University Hospital
Lead sponsor
Göteborg University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: