Daily 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.
ID
Bron
Verkorte titel
Aandoening
COPD, supplementation, antioxidants, rehabilitation
COPD, supplementatie, antioxidatnen, revalidatie
Ondersteuning
Director NUTRIM
University Maastricht
Postbus 616
6200 MD Maastricht
the Netherlands
P.O.Box 7005
6700 CA Wageningen
the Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Study 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.
Doel van het onderzoek
Daily 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.
Onderzoeksproduct en/of interventie
Nutritional supplement enriched with antioxidants vs. iso-caloric placebo
Publiek
Centre for Integrated Rehabilitation of Organ Failure (CIRO)
EPA Rutten
Hornerheide 1
Horn 6080NM
The Netherlands
ericarutten@proteion.nl
Wetenschappelijk
Centre for Integrated Rehabilitation of Organ Failure (CIRO)
EPA Rutten
Hornerheide 1
Horn 6080NM
The Netherlands
ericarutten@proteion.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL991 |
| NTR-old | NTR1020 |
| Ander register | : |
| ISRCTN | ISRCTN62421408 |