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

Sponsor
Queen's University, Belfast (Other)
Overall Status
Completed
CT.gov ID
NCT00435708
Collaborator
(none)
81
1
2
31
2.6

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: 5 portions fruit and vegetables/day
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
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)
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Self-reported intake of fruit and vegetables (number of portions per day); Markers of airway inflammation in induced sputum [12 weeks]

Secondary Outcome Measures

  1. Biochemical markers of nutritional status; systemic and airway oxidative stress; systemic inflammation [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT00435708
Other Study ID Numbers:
  • Ref 200651
First Posted:
Feb 15, 2007
Last Update Posted:
Sep 29, 2015
Last Verified:
Sep 1, 2015
Keywords provided by Queen's University, Belfast
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2015