NCT06735573

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

December 5, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 6, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

December 5, 2024

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Association between dietary protein and the prevalence of sarcopenic obesity

    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 Outcomes (1)

  • Association between dietary protein and lung functions outcomes

    through study completion, an average of 1 year

Interventions

Primary Objective The primary objective is to measure the relationship between the quantity and source of dietary protein intake, and the prevalence of sarcopenic obesity, and lung function outcomes, in older female participants with clinically diagnosed COPD. Secondary Objectives The secondary objective is to investigate whether the level of inflammation (plasma CRP) is associated with the intake of total, plant-based and animal-based protein, with the prevalence of sarcopenic obesity, and with lung function outcomes.

Also known as: the level of inflammation (plasma CRP)

Eligibility Criteria

Age55 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale with COPD aged 55 and over
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with clinically diagnosed COPD, from GP practices in Aberdeen,United Kingdom, through the Primary Care Research Network.

You may qualify if:

  • Women.
  • Clinically diagnosed with COPD.
  • Aged 55 years or older.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baukje de Roos

Aberdeen, Scotland, AB25 2ZD, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A single blood sample will be taken by venepuncture (usually from the antecubital vein) by a trained phlebotomist, after at least 9 hours of fasting overnight. The blood sample will be collected into a heparin tube and spun (for 15 minutes at 2000 x g) to obtain plasma. Plasma samples will be stored at - 80°C until batch analysis of high-sensitivity C-reactive protein (hs-CRP) levels, using the Konelab Clinical Analyser at the Rowett Institute, the University of Aberdeen, Aberdeen, United Kingdom.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 16, 2024

Study Start

January 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 6, 2026

Record last verified: 2026-02

Locations