Clinical trial NCT00435708: Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD)
Official title: Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Fruit
Vegetables
Oxidative stress
Inflammation
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2007-02-15
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Self-reported Intake of Fruit and Vegetables (Number of Portions Per Day);
timeFrame: 12 weeks
measure: Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane
timeFrame: 12 Weeks
Secondary outcomes:
measure: Biochemical Markers of Nutritional Status Plasma Vitamin C
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Co.Antrim
Study officials:
affiliation: Queen's University, Belfast
name: Ian Young, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.