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Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Diet rich in antioxidants
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Lung function, Chronic obstructive pulmonary disease, Antioxidants

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Argalasti Health Centre-University of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

Diet rich in antioxidants

Arm Description

Free diet

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.

Outcomes

Primary Outcome Measures

Lung function decline

Secondary Outcome Measures

Full Information

First Posted
April 16, 2009
Last Updated
April 20, 2009
Sponsor
University of Thessaly
Collaborators
ARGALASTI HEALTH CENTRE
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1. Study Identification

Unique Protocol Identification Number
NCT00884299
Brief Title
Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Nutritional Enhancement in COPD: Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Thessaly
Collaborators
ARGALASTI HEALTH CENTRE

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Lung function, Chronic obstructive pulmonary disease, Antioxidants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Free diet
Arm Title
Diet rich in antioxidants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet rich in antioxidants
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung function decline
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LIANA KERANIS, MD
Organizational Affiliation
University of Thessaly, Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Argalasti Health Centre-University of Thessaly
City
Volos
State/Province
Thessaly
ZIP/Postal Code
38221
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
20150206
Citation
Keranis E, Makris D, Rodopoulou P, Martinou H, Papamakarios G, Daniil Z, Zintzaras E, Gourgoulianis KI. Impact of dietary shift to higher-antioxidant foods in COPD: a randomised trial. Eur Respir J. 2010 Oct;36(4):774-80. doi: 10.1183/09031936.00113809. Epub 2010 Feb 11.
Results Reference
derived

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Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)

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