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Sponsored by: |
Queen's University, Belfast |
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Information provided by: | Queen's University, Belfast |
ClinicalTrials.gov Identifier: | NCT00435708 |
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 |
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Chronic Obstructive Pulmonary Disease |
Behavioral: 5 portions fruit and vegetables/day Behavioral: <= 2 portions fruit and vegetables/day |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD) |
Estimated Enrollment: | 80 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
<= 2 portions fruit and vegetables/day'
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Behavioral: <= 2 portions fruit and vegetables/day
Participants continue to consume usual diet containing <= 2 portions fruit and veg per day
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2: Experimental
5 portions fruit and vegetables/day
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Behavioral: 5 portions fruit and vegetables/day
Participants consume > = 5 portions fruit and veg per day
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michelle McKinley, PhD | +44(0)2890632685 | m.mckinley@qub.ac.uk |
United Kingdom, Co.Antrim | |
Queen's University Belfast | Recruiting |
Belfast, Co.Antrim, United Kingdom, BT12 6BJ | |
Principal Investigator: Ian Young, MD | |
Sub-Investigator: Stuart Elborn, MD | |
Sub-Investigator: Michelle McKinley, PhD | |
Sub-Investigator: Jayne Woodside, PhD | |
Sub-Investigator: Madeleine Ennis, PhD | |
Sub-Investigator: Bettina Schock, PhD |
Principal Investigator: | Ian Young, MD | Queen's University, Belfast |
Responsible Party: | Lecturer ( Dr M McKinley ) |
Study ID Numbers: | Ref 200651 |
Study First Received: | February 14, 2007 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00435708 History of Changes |
Health Authority: | United Kingdom: Research Ethics Committee |
COPD Fruit Vegetables Oxidative stress Inflammation |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Stress Inflammation Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |