search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Reduction of oxidative stress in COPD by a combination of exercise and nutrition


- candidate number2661
- NTR NumberNTR1020
- ISRCTNISRCTN62421408
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR12-jul-2007
- Secondary IDs 
- Public TitleReduction of oxidative stress in COPD by a combination of exercise and nutrition
- Scientific TitleThe effect of nutritional supplementation as adjunct to exercise training on resting and exercise-induced oxidative stress, muscle function and exercise capacity in severe COPD patients.
- ACRONYMROXCEN
- hypothesisDaily ingestion of a nutritional supplement enriched with antioxidants during 8 weeks pulmonary rehabilitation results in a decreased oxidative stress in rest and after exercise in COPD patients compared to an iso-caloric placebo.
- Healt Condition(s) or Problem(s) studiedRehabilitation, COPD, Antioxidants, Supplements
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-okt-2007
- planned closingdate1-mrt-2008
- Target number of participants30
- InterventionsNutritional supplement enriched with antioxidants vs. iso-caloric placebo
- Primary outcomeTo 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 outcomeTo 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.
- Timepoints
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD EPA Rutten
- CONTACT for SCIENTIFIC QUERIESPhD EPA Rutten
- Sponsor/Initiator University Maastricht (UM), NUTRIM
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- Publications
- Brief summaryStudy to evaluate the effect of daily placebo-controlled nutritional supplementation enriched with antioxidants on the resting and exercise-induced oxidative stress in patients with COPD following a pulmonary rehabilitation.
- Main changes (audit trail)
- RECORD12-jul-2007 - 27-aug-2007


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl