Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)

NCT00884299 | Completed DMC

• 1 other identifier: LK19021970DM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Lung function; Chronic obstructive pulmonary disease; Antioxidants

Outcome Measures

Primary Outcomes (1)

• Lung function decline

  3 years

Study Arms (2)

1

NO INTERVENTION

Free diet

Diet rich in antioxidants

EXPERIMENTAL

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

Interventions

Diet rich in antioxidants DIETARY_SUPPLEMENT

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.

Diet rich in antioxidants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• A history of lung cancer, bronchial asthma or other respiratory disease

Sponsors & Collaborators

• University of Thessaly: lead
• ARGALASTI HEALTH CENTRE: collaborator

Study Sites (1)

Argalasti Health Centre-University of Thessaly

Volos, Thessaly, 38221, Greece

Location

Related Publications (1)

• 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.

  PMID: 20150206 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• LIANA KERANIS, MD

  University of Thessaly, Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 20, 2009
• Study Start: January 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: April 1, 2009
• Last Updated: April 21, 2009

Record last verified: 2009-04

Locations

GR (1)