Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Nutritional Enhancement in COPD: Randomized, Controlled Trial
Verified date | April 2009 |
Source | University of Thessaly |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Interventional |
Chronic obstructive pulmonary disease (COPD) is characterized by increased oxidative stress
which aggravates airway and systemic inflammation. Previous studies suggested that dietary
factors such as ample consumption of antioxidants might have beneficial effects in lung
function in COPD patients.
The investigators' primary aim is therefore to investigate prospectively whether a
nutritional intervention consisted of diet rich in antioxidants such as fresh fruits and
vegetables, would significantly affect lung function decline in COPD patients compared to a
free diet.
Methods: This is a 3-year prospective study, incorporating a run-in period of six months and
outpatient clinic visits, scheduled every 6 months. Consecutive sampling was used to recruit
120 patients with COPD. At baseline and at each visit all patients were evaluated for
respiratory symptoms, dietary habits, medication used and pulmonary function. Patients will
be randomized either to a diet based on increased consumption of foods containing
antioxidants (fresh fruits and vegetables), intervention group (IG) or, to a free diet,
control group (CG).
The investigators hypothesize that the results from the study will suggest that a diet rich
in antioxidants may be associated with improvement in lung function in COPD patients. In
this respect dietary interventions should be considered in the management of COPD.
Status | Completed |
Enrollment | 120 |
Est. completion date | April 2009 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of COPD according to the GOLD definition* - Ability to perform spirometry. (*Pauwels RA, Buist AS, Calverley PM, et al. Global strategy for the diagnosis, management and prevention of Chronic Obstructive Pulmonary disease. NHLBI/WHO Global initiative for Chronic Obstructive Lung Disease (GOLD). Workshop summary. Am J Respir Crit Care Med 2001; 163(5):1256-1276.) Exclusion Criteria: - A history of lung cancer, bronchial asthma or other respiratory disease - Continuous use of systemic steroids more than 30 days prior was used as exclusion criteria |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Argalasti Health Centre-University of Thessaly | Volos | Thessaly |
Lead Sponsor | Collaborator |
---|---|
University of Thessaly | ARGALASTI HEALTH CENTRE |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lung function decline | 3 years | No |
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