- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06735573
Protein, Sarcopenic Obesity, and COPD (PROSO-COPD)
April 30, 2026 updated by: University of Aberdeen
Observational Study to Explore the Relationship Between Dietary Protein Intake and the Prevalence of Sarcopenic Obesity in Adult Female With Chronic Obstructive Pulmonary Disease (COPD): A Pilot Study
Both sarcopenic obesity and chronic obstructive pulmonary diseases (COPD) are common conditions that mainly affect middle-aged and older adults.
Previous research has shown that increased dietary intake of total and plant-based protein is associated with a lower risk of sarcopenic obesity, using data from the EPIC Norfolk study.
Furthermore, a systematic review and meta-analysis showed that having sarcopenic obesity was associated with significantly impaired lung function outcomes.
Other research has shown that increased intake of dietary protein leads to a better treatment outcome for respiratory diseases.
The aim of this pilot observational study is to investigate, in more detail, the relationship between the quantity and source of dietary protein intake, the prevalence of sarcopenic obesity, and lung function, in a small cohort of older female participants with COPD.
The study will also consider the role of inflammation in relation to sarcopenic obesity and lung function outcomes.
This study will help to improve the understanding of the relationship between sarcopenic obesity and lung function outcomes, and how dietary protein intake and inflammation can affect this relationship and each of the outcomes.
Study Overview
Status
Enrolling by invitation
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Scotland
-
Aberdeen, Scotland, United Kingdom, AB25 2ZD
- Baukje de Roos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Women with clinically diagnosed COPD, from GP practices in Aberdeen,United Kingdom, through the Primary Care Research Network.
Description
Inclusion Criteria:
- Women.
- Clinically diagnosed with COPD.
- Aged 55 years or older.
Exclusion Criteria:
- Male.
- Women who are 54 years or younger.
- Those who have dementia.
- Unable to read or write in English.
- Unable to attend the Human Intervention Studies Unit.
- Those within one year life expectancy.
- Those who have cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between dietary protein and the prevalence of sarcopenic obesity
Time Frame: through study completion, an average of 1 year
|
Association between dietary intake of total, plant-based and animal-based protein and the prevalence of sarcopenic obesity.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between dietary protein and lung functions outcomes
Time Frame: through study completion, an average of 1 year
|
Association between dietary intake of total, plant-based and animal-based protein and lung functions outcomes (Forced Vital Capacity (FVC), Forced Expiratory Volume in The First Second(FEV1), and The Ratio of Forced Expiratory Volume in The First Second to Forced Vital Capacity (FEV1/FVC ratio)).
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2026
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 10, 2024
First Posted (Actual)
December 16, 2024
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T Baabbad
- University of Aberdeen (Other Identifier: University of Aberdeen)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It is not yet known if there will be a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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