Reduction of oxidative stress in COPD by a combination of exercise and nutritio
- Conditions
- COPD, supplementation, antioxidants, rehabilitationCOPD, supplementatie, antioxidatnen, revalidatie
- Registration Number
- NL-OMON21716
- Lead Sponsor
- AMWJ Schols, Prof Director NUTRIMUniversity MaastrichtPostbus 6166200 MD Maastrichtthe Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
1. Diagnosis of COPD according to the American Thoracic Society (ATS) GOLD guidelines (FEV1 < 60% predicted and FEV1/FVC < 70% and < 10% predicted improvement in FEV1 after b2-agonist inhalation (14, 15));
2. Both male and female, age-range from 40 to 75 years;
3. No respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study;
4. Capable to provide informed consent;
5. Presence of other chronic diseases is allowed in case the clinical status is stable for at least 4 weeks before the study.
1. Inability to perform the incremental cycle ergometer test;
2. Chronic use of antioxidants or vitamin supplements;
3. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements;
4. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
5. Specific allergy or intolerance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To asses the effect of daily ingestion of a nutritional supplement enriched with antioxidants during 8 weeks pulmonary rehabilitation on resting and exercise-induced oxidative stress in COPD patients compared to an iso-caloric placebo. Oxidative stress will be measured by specific biomarkers in exhaled air, breath condensate, urine and venous blood.
- Secondary Outcome Measures
Name Time Method To examine the effects of daily ingestion of a nutritional supplement enriched with antioxidants during pulmonary rehabilitation on respiratory and skeletal muscle strength and exercise capacity in COPD patients.