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Not yet recruitingNCT07159594Updated Sep 8, 2025

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

An interventional study of Energy restriction in COPD and Obesity &Amp; Overweight, sponsored by Sahlgrenska University Hospital. Not yet recruiting. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Other
    Energy restriction

    One arm will start as control group

    Other: Energy restriction

  • Other
    Energy restriction delayed

    delayed

    Other: Energy restriction

Interventions

  • OtherEnergy restriction

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

    Also known as: Energy restriction delayed

06

What researchers measure

Primary outcomes

  1. 6 minute walking test

    Time frame: 20 weeks

Secondary outcomes

  1. Lung function

    FEV₁ (Forced Expiratory Volume in 1 second) FVC (Forced Vital Capacity) FEV₁/FVC ratio

    Time frame: 20 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Will be added later

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07159594
Lead sponsor
Sahlgrenska University Hospital
Collaborators
Göteborg University
Responsible party
Jenny van Odijk (Docent, Sahlgrenska University Hospital) — Principal investigator
First posted
Sep 8, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Sep 8, 2025

Study contacts

Jenny van Odijk, Docent
Contact
jenny.vanodijk@nutrition.gu.se
+46076-6183709

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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