Standardized dietary challenge to monitor effects of rehabilitation program in patients with COPD: a pilot study
Recruiting
- Conditions
- COPDemphysema and chronic bronchits1000301810038716
- Registration Number
- NL-OMON54507
- Lead Sponsor
- CIRO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
- Objective diagnosis of COPD
- Approval for a pulmonary rehabilitation program (inpatient or outpatient) of
Ciro after start assessment
Exclusion Criteria
- Clinically important pulmonary disease other than COPD
- Participation in an investigational drug within 3 months prior to screening.
- Unacceptable concomitant medication use at baseline, e.g., drugs known or
likely to interact with the challenge drink or study assessments.
- Reported food allergy or sensitivity for one of the used ingredients of the
Phenflex shake
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is to explore if there is an association between the<br /><br>pulmonary rehabilitation and the *metabolic age* or metabolic resilience,<br /><br>measured with the composite biomarker. The composite biomarker is based on<br /><br>blood response curves (t=0, 30, 60, 120 and 240 minutes) of six blood<br /><br>parameters after consumption of the PhenFlex drink: glucose, C-peptide,<br /><br>non-esterified fatty acids, cholesterol, HDL-cholesterol, triglycerides. The<br /><br>parameters are measured in blood. The composite biomarker will be reported as a<br /><br>health score, which is calculated by combining the outcome of the separate<br /><br>measures.</p><br>
- Secondary Outcome Measures
Name Time Method