Reduction of OXidative stress in Chronic Obstructive Pulmonary Disease by Exercise and Nutrition

ISRCTN	ISRCTN62421408
DOI	https://doi.org/10.1186/ISRCTN62421408
Protocol serial number	N/A
Sponsor	Numico Research B.V. (The Netherlands)
Funder	Numico Research B.V. (The Netherlands)

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

Research, Development and Education
Centre for Integrated Rehabilitation of Organ Failure (CIRO)
Horn
6080 NM
Netherlands

Email	ericarutten@proteion.nl

Study information

Primary study design	Interventional
Study design	Double-blind placebo controlled parallel intervention study
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan