- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435708
Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD) (DISCO)
February 16, 2024 updated by: Michelle McKinley, Queen's University, Belfast
Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Co.Antrim
-
Belfast, Co.Antrim, United Kingdom, BT12 6BJ
- Queen's University Belfast
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Low fruit and vegetables
Control - two or less portions fruit and vegetables/day
|
|
|
Experimental: High fruit and vegetables
5 portions fruit and vegetables/day
|
Participants consume > = 5 portions fruit and veg per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported Intake of Fruit and Vegetables (Number of Portions Per Day);
Time Frame: 12 weeks
|
A series of 7-day diet histories were completed by each participant at weeks 0 and 12 in order to assess baseline diet and self-reported compliance with the intervention; average daily FV intake was then hand-counted from these records;
|
12 weeks
|
|
Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane
Time Frame: 12 Weeks
|
Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane ng/ml
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemical Markers of Nutritional Status Plasma Vitamin C
Time Frame: 12 weeks
|
Plasma vitamin C concentration umol/L
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ian Young, MD, Queen's University, Belfast
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
February 14, 2007
First Submitted That Met QC Criteria
February 14, 2007
First Posted (Estimated)
February 15, 2007
Study Record Updates
Last Update Posted (Actual)
July 31, 2024
Last Update Submitted That Met QC Criteria
February 16, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ref 200651
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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