Contact information
Type
Scientific
Primary contact
Dr E.P.A. Rutten
ORCID ID
Contact details
Research
Development and Education
Centre for Integrated Rehabilitation of Organ Failure (CIRO)
Horn
6080 NM
Netherlands
ericarutten@proteion.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
ROXCEN
Study hypothesis
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
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).
Study design
Double-blind placebo controlled parallel intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Intervention
Nutritional supplement enriched with antioxidants versus iso-caloric placebo.
Intervention type
Supplement
Phase
Not Specified
Drug names
Nutritional 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 trial start date
01/10/2007
Overall trial end date
01/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
01/10/2007
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Research, Development and Education
Horn
6080 NM
Netherlands
Sponsor information
Organisation
Numico Research B.V. (The Netherlands)
Sponsor details
P.O.Box 7005
Wageningen
6700 CA
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Numico Research B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list