Reduction of OXidative stress in Chronic Obstructive Pulmonary Disease by Exercise and Nutrition
ISRCTN | ISRCTN62421408 |
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DOI | https://doi.org/10.1186/ISRCTN62421408 |
Secondary identifying numbers | N/A |
- Submission date
- 23/08/2007
- Registration date
- 23/08/2007
- Last edited
- 06/05/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr E.P.A. Rutten
Scientific
Scientific
Research, Development and Education
Centre for Integrated Rehabilitation of Organ Failure (CIRO)
Horn
6080 NM
Netherlands
ericarutten@proteion.nl |
Study information
Study design | Double-blind placebo controlled parallel intervention study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | The effect of nutritional supplementation as adjunct to exercise training on resting and exercise-induced oxidative stress, muscle function and exercise capacity in severe Chronic Obstructive Pulmonary Disease patients |
Study acronym | ROXCEN |
Study objectives | Daily ingestion of a nutritional supplement enriched with antioxidants during eight weeks pulmonary rehabilitation results in a decreased oxidative stress in rest and after exercise in Chronic Obstructive Pulmonary Disease (COPD) patients compared to an iso-caloric placebo. |
Ethics approval(s) | Ethics approval received from the Ethical Commission of the METC of Maastricht on the 19th September 2007 (ref: NL17788.068.07/MEC 07-3-066). |
Health condition(s) or problem(s) studied | Chronic Obstructive Pulmonary Disease (COPD) |
Intervention | Nutritional supplement enriched with antioxidants versus iso-caloric placebo. |
Intervention type | Supplement |
Primary outcome measure | To assess the effect of daily ingestion of a nutritional supplement enriched with antioxidants during eight 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, measured at the start of the rehabilitation and after eight weeks. |
Secondary outcome measures | 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, measured at the start of the rehabilitation and after eight weeks. |
Overall study start date | 01/10/2007 |
Completion date | 01/07/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 30 |
Key inclusion criteria | 1. Diagnosis of COPD according to the American Thoracic Society (ATS) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (Forced Expiratory Volume in one second [FEV1] less than 60% predicted and FEV1/Forced Vital Capacity [FVC] less than 70% and less than 10% predicted improvement in FEV1 after b2-agonist inhalation 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 four 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 four weeks before the study |
Key exclusion criteria | 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 |
Date of first enrolment | 01/10/2007 |
Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Research, Development and Education
Horn
6080 NM
Netherlands
6080 NM
Netherlands
Sponsor information
Numico Research B.V. (The Netherlands)
Industry
Industry
P.O.Box 7005
Wageningen
6700 CA
Netherlands
Website | http://www.numico.com |
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https://ror.org/00aj77a24 |
Funders
Funder type
Industry
Numico Research B.V. (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |