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

Chronic Obstructive Pulmonary Disease Clinical Trial

— DISCO  

Official title:

Effect of Increased Fruit and Vegetable Intake on Airway Inflammation and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435708
• Other study ID #: Ref 200651
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2007
• Last updated: September 28, 2015
• Start date: February 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2015
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• 5 portions fruit and vegetables/day
Participants consume > = 5 portions fruit and veg per day

Locations

Country	Name	City	State
United Kingdom	Queen's University Belfast	Belfast	Co.Antrim

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University, Belfast

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported intake of fruit and vegetables (number of portions per day); Markers of airway inflammation in induced sputum		12 weeks	No
Secondary	Biochemical markers of nutritional status; systemic and airway oxidative stress; systemic inflammation		12 weeks	No