‘Standardized dietary challenge in patients with COPD: a pilot study
- Conditions
- COPD
- Registration Number
- NL-OMON26982
- Lead Sponsor
- Ciro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Objective diagnosis of COPD
-Males
-Age range from 40-59 year
-No carcinogenic events for the last 5 years
-Capability to read and understand the study protocol
-N=10 lean body composition: BMI between 20 and 25 kg/m2 with a normal FFMI (> percentile 5 according to Franssen et al. ) and without metabolic syndrome).
-N=10 with metabolic syndrome according to international criteria.
-Clinically important pulmonary disease other than COPD (e.g. but not limited to active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, lung cancer, asthma as primary or main diagnosis) or other pulmonary disorder as judged by the Investigator.
-An increase in complaints of the lungs defined by a physician as an exacerbation COPD within 4 weeks of the routine baseline assessment and between the period of routine baseline assessment and the first test day.
-Participation in an investigational drug within 3 months prior to screening.
-Loss of blood outside the limits of Sanquin (500 mL) within 3 months prior to screening or not willing to refrain from blood- or plasma donation during the study.
-Average alcohol consumption > 21 units/week.
-Unacceptable concomitant medication use at baseline, e.g., drugs known or likely to interact with the challenge drink or study assessments.
oUse of non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen, aspirin), statins, and beta-blockers is not allowed during the evening before and during the test days. Patients are eligible after approval by the doctor to stop the abovementioned medication the evening before and during the nutritional challenge test days.
-Reported food allergy or sensitivity for one of the used ingredients of the Phenflex shake.
-Not willing to accept information transfer which concerns participation in the study or information regarding health (e.g. laboratory results, findings at health and lifestyle questionnaire, physical examination or eventual adverse events) to and from their general practitioner.
-Unintentional weight loss or gain > 5% body weight in the last month.
-Clinically significant abnormalities, as judged by the investigator, in laboratory test results. In the case of uncertain or questionable results, tests performed during screening may be repeated once before determination of eligibility. This will be judged by the physician.
-Inappropriate veins for cannula insertion.
-Having a chronic auto-immune disease (such as arthritis).
-Having a history or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, gastrointestinal, hepatic, or renal disorder.
-Unwillingness or inability to comply with the study protocol for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method What is the phenotypic flexibility of COPD patients before and after a comprehensive pulmonary rehabilitation program?
- Secondary Outcome Measures
Name Time Method