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

NCT ID: NCT00435708

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-09-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low fruit and vegetables

Control - two or less portions fruit and vegetables/day

Group Type: NO_INTERVENTION

No interventions assigned to this group

High fruit and vegetables

5 portions fruit and vegetables/day

Group Type: EXPERIMENTAL

5 portions fruit and vegetables/day

Intervention Type: BEHAVIORAL

Participants consume \> = 5 portions fruit and veg per day

Interventions

5 portions fruit and vegetables/day

Participants consume \> = 5 portions fruit and veg per day

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Michelle McKinley

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian Young, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Queen's University Belfast

Belfast, Co.Antrim, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 22088966 (View on PubMed)

Other Identifiers

Ref 200651

Identifier Type: -

Identifier Source: org_study_id