The Impact of a Weight Reduction Intervention on Clinical Outcomes in Patients With Obesity and COPD

NCT ID: NCT07159594

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-06-30

Brief Summary

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.

Conditions

COPD; Obesity &Amp; Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Energy restriction

One arm will start as control group

Group Type: OTHER

Energy restriction

Intervention Type: OTHER

Diet with LED and energy restricted diet with gradually inclusion of meals

Energy restriction delayed

delayed

Group Type: OTHER

Energy restriction

Intervention Type: OTHER

Diet with LED and energy restricted diet with gradually inclusion of meals

Interventions

Energy restriction

Diet with LED and energy restricted diet with gradually inclusion of meals

Intervention Type: OTHER

Other Intervention Names

Energy restriction delayed

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jenny van Odijk

Docent

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jenny van Odijk, Docent

Role: CONTACT

jenny.vanodijk@nutrition.gu.se

+46076-6183709

Other Identifiers

SahlgrenskaUH03610

Identifier Type: -

Identifier Source: org_study_id