Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
ARGALASTI HEALTH CENTRE
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT00884299
First received: April 16, 2009
Last updated: April 20, 2009
Last verified: April 2009
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
Dietary Supplement: Diet rich in antioxidants

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutritional Enhancement in COPD: Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • Lung function decline [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: January 2004
Study Completion Date: April 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Free diet
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884299

Locations
Greece
Argalasti Health Centre-University of Thessaly
Volos, Thessaly, Greece, 38221
Sponsors and Collaborators
University of Thessaly
ARGALASTI HEALTH CENTRE
Investigators
Principal Investigator: LIANA KERANIS, MD University of Thessaly, Medical School
  More Information

No publications provided by University of Thessaly

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LIANA KERANIS, ARGALASTI HEALTH CENTRE
ClinicalTrials.gov Identifier: NCT00884299     History of Changes
Other Study ID Numbers: LK19021970DM
Study First Received: April 16, 2009
Last Updated: April 20, 2009
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by University of Thessaly:
Lung function
Chronic obstructive pulmonary disease
Antioxidants

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014