The effect of targeted nutrient supplementation on physical activity and health related quality of life in COPD

Recruiting

• Conditions: Chronic obstructive pulmonary disease; 10028302; 10009841; 10006436

• Registration Number: NL-OMON52907
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 198

Inclusion Criteria

COPD patients NUTRECOVER trial:

- COPD patients with moderate to very severe disease stage according to GOLD
criteria (i.e. GOLD stage II-IV);
- Medically stable in the opinion of the investigator.

Reference group microbiome study:

- Lung function: FEV1/FVC > 0.7
- Medically stable in the opinion of the investigator.

Exclusion Criteria

COPD patients NUTRECOVER trial:
Exclusion criteria indicated with an asterisk (*) are also exclusion criteria
for the subjects in the reference group for the microbiome study.

- Age <18 years;*
- Allergy or intolerance to components of the study product;
- Investigator*s uncertainty about the willingness or ability of the patient to
comply with the protocol requirements (e.g. leg amputation) or patients
suffering from other acute or unstable chronic diseases that will compromise
the study outcome (e.g. active cancer requiring treatment);*
- Participation in any other study involving investigational or marketed
products concomitantly or within four weeks prior to entry into the study;*
- Patients with terminal illness;*
- Recent hospital admission (<4 weeks prior to the start of the study);*
- COPD patients with temporary oral steroid or antibiotics use due to a COPD
exacerbation in the last 4 weeks or subjects in the reference group with
antibiotics use for any reason in the last 4 weeks;
- Lung malignancy in the previous 5 years;*
- Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer*s
disease, Parkinson*s disease, Huntington*s chorea, frontotemporal dementia) in
the medical records;*
- Recent diagnosis of cerebral conditions (< 1 year e.g. cerebral infarction,
hemorrhage, brain tumors, transient ischemic attack) in the medical records;*
- Any medical condition that significantly interferes with digestion and/or
gastro-intestinal function (e.g. short bowel syndrome, inflammatory bowel
disease, gastric ulcers, gastritis, (gastro)-enteritis, GI cancer as judged by
the investigator;*
-Subjects in the reference group in the microbiome study: diagnosis of any
chronic lung disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Physical activity level<br /><br>- General health status</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Mental health<br /><br>- Physical performance<br /><br>- Blood markers<br /><br>- Patient related outcomes<br /><br>- Gut health</p><br>