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Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD) (DISCO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00435708
First Posted: February 15, 2007
Last Update Posted: September 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Queen's University, Belfast
  Purpose
Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is estimated to cost the health service close to £1 billion every year. Around 80,000 people in Northern Ireland suffer from COPD. COPD is clinically defined as a slowly progressive condition characterised by airflow limitation, which is largely irreversible. Chronic inflammation and oxidative stress are key components of the underlying pathological process resulting in airflow limitation. Dietary factors and nutrients that have antioxidant or anti-inflammatory properties are therefore of interest with respect to the aetiology of COPD. The antioxidant vitamins C, E and beta-carotene are all present in the lung milieu. Such antioxidants represent the lung's first line of defence against oxygen free radicals. Observational studies indicate that a low dietary intake of antioxidant nutrients, or foods rich in antioxidants (e.g. fruit and vegetables), is associated with decreased lung function and increased risk of COPD. To date, there have been no food-based dietary interventions investigating the effect of increased fruit and vegetable intake on COPD. The investigators propose to recruit people with mild to moderate COPD and low fruit and vegetable intakes (<=2 portions daily) and randomise them to one of two study arms for 12 weeks - either to increase fruit and vegetable consumption to at least 5 portions a day, or to follow their normal diet. Airway and systemic oxidative stress and inflammation will be assessed at baseline and post-intervention in order to determine if fruit and vegetables have the potential to alleviate the oxidative stress and airway inflammation associated with COPD.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Behavioral: 5 portions fruit and vegetables/day Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • Self-reported intake of fruit and vegetables (number of portions per day); Markers of airway inflammation in induced sputum [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Biochemical markers of nutritional status; systemic and airway oxidative stress; systemic inflammation [ Time Frame: 12 weeks ]

Enrollment: 81
Study Start Date: February 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2
5 portions fruit and vegetables/day
Behavioral: 5 portions fruit and vegetables/day
Participants consume > = 5 portions fruit and veg per day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate to severe COPD (according to GOLD classification)
  • oxygen saturation >= 92 KPa
  • symptomatically stable
  • habitually low fruit and vegetable intakes (<=2 portions daily)
  • exercise limited by shortness of breath (rather than e.g. angina, arthritis)

Exclusion Criteria:

  • diabetes
  • taking antioxidant supplements or drugs
  • oxygen saturation <8KPa
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00435708


Locations
United Kingdom
Queen's University Belfast
Belfast, Co.Antrim, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Ian Young, MD Queen's University, Belfast
  More Information

Publications:
Responsible Party: Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT00435708     History of Changes
Other Study ID Numbers: Ref 200651
First Submitted: February 14, 2007
First Posted: February 15, 2007
Last Update Posted: September 29, 2015
Last Verified: September 2015

Keywords provided by Queen's University, Belfast:
COPD
Fruit
Vegetables
Oxidative stress
Inflammation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases