Clinical Trials Directory

Trials / Completed

CompletedNCT00884299

Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)

Nutritional Enhancement in COPD: Randomized, Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
University of Thessaly · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTDiet rich in antioxidantsDietary intervention based on diet with increased consumption of foods containing antioxidants such as fresh fruits, fruit juices and vegetables. Patients are advised by a physician and a specialist nurse during regular scheduled outpatient clinic visits to increase fresh fruit /fruit juices/vegetable consumption of at least one portion per day compared to baseline and to maintain this regime throughout the study period.

Timeline

Start date
2004-01-01
Primary completion
2008-03-01
Completion
2009-04-01
First posted
2009-04-20
Last updated
2009-04-21

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT00884299. Inclusion in this directory is not an endorsement.