Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)
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| ClinicalTrials.gov Identifier: NCT00884299 |
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Recruitment Status :
Completed
First Posted : April 20, 2009
Last Update Posted : April 21, 2009
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Dietary Supplement: Diet rich in antioxidants | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Nutritional Enhancement in COPD: Randomized, Controlled Trial |
| Study Start Date : | January 2004 |
| Actual Primary Completion Date : | March 2008 |
| Actual Study Completion Date : | April 2009 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: 1
Free diet
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Experimental: Diet rich in antioxidants
Diet with increased consumption of foods containing antioxidants such as fresh fruits, fruit juices and vegetables. Patients in this arm will be seen regularly in the outpatient clinic where there will be informed for the potential beneficial effects of fruits and vegetables in health status by two members of the study team (attending physician and specialist nurse). At baseline and at each visit it is clearly explained to them that the dietary goal is 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 3-year study period.
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Dietary Supplement: Diet rich in antioxidants
Dietary 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. |
- Lung function decline [ Time Frame: 3 years ]
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884299
| Greece | |
| Argalasti Health Centre-University of Thessaly | |
| Volos, Thessaly, Greece, 38221 | |
| Principal Investigator: | LIANA KERANIS, MD | University of Thessaly, Medical School |
| Responsible Party: | LIANA KERANIS, ARGALASTI HEALTH CENTRE |
| ClinicalTrials.gov Identifier: | NCT00884299 |
| Other Study ID Numbers: |
LK19021970DM |
| First Posted: | April 20, 2009 Key Record Dates |
| Last Update Posted: | April 21, 2009 |
| Last Verified: | April 2009 |
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Lung function Chronic obstructive pulmonary disease Antioxidants |
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |
Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |