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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
5 portions fruit and vegetables/day
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Fruit, Vegetables, Oxidative stress, Inflammation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen's University Belfast

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

5 portions fruit and vegetables/day

Outcomes

Primary Outcome Measures

Self-reported intake of fruit and vegetables (number of portions per day); Markers of airway inflammation in induced sputum

Secondary Outcome Measures

Biochemical markers of nutritional status; systemic and airway oxidative stress; systemic inflammation

Full Information

First Posted
February 14, 2007
Last Updated
September 28, 2015
Sponsor
Queen's University, Belfast
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1. Study Identification

Unique Protocol Identification Number
NCT00435708
Brief Title
Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD)
Acronym
DISCO
Official Title
Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen's University, Belfast

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Fruit, Vegetables, Oxidative stress, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Experimental
Arm Description
5 portions fruit and vegetables/day
Intervention Type
Behavioral
Intervention Name(s)
5 portions fruit and vegetables/day
Intervention Description
Participants consume > = 5 portions fruit and veg per day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Biochemical markers of nutritional status; systemic and airway oxidative stress; systemic inflammation
Time Frame
12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Young, MD
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University Belfast
City
Belfast
State/Province
Co.Antrim
ZIP/Postal Code
BT12 6BJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22088966
Citation
Baldrick FR, Elborn JS, Woodside JV, Treacy K, Bradley JM, Patterson CC, Schock BC, Ennis M, Young IS, McKinley MC. Effect of fruit and vegetable intake on oxidative stress and inflammation in COPD: a randomised controlled trial. Eur Respir J. 2012 Jun;39(6):1377-84. doi: 10.1183/09031936.00086011. Epub 2011 Nov 16.
Results Reference
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Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD)

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