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

NCT00435708 | Completed Results

• 1 other identifier: Ref 200651
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; Fruit; Vegetables; Oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (2)

• Self-reported Intake of Fruit and Vegetables (Number of Portions Per Day);

  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

  Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane ng/ml

  12 Weeks

Secondary Outcomes (1)

• Biochemical Markers of Nutritional Status Plasma Vitamin C

  12 weeks

Study Arms (2)

Low fruit and vegetables

NO INTERVENTION

Control - two or less portions fruit and vegetables/day

High fruit and vegetables

EXPERIMENTAL

5 portions fruit and vegetables/day

Behavioral: 5 portions fruit and vegetables/day

Interventions

5 portions fruit and vegetables/day BEHAVIORAL

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

High fruit and vegetables

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• diabetes
• taking antioxidant supplements or drugs
• oxygen saturation \<8KPa

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Queen's University Belfast

Belfast, Co.Antrim, BT12 6BJ, United Kingdom

Location

Related 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(6):1377-84. doi: 10.1183/09031936.00086011. Epub 2011 Nov 16.

  PMID: 22088966 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Michelle McKinley
• Organization: Queen's University Belfast

m.mckinley@qub.ac.uk

02890978936

Study Officials

• Ian Young, MD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2007
• First Posted: February 15, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-02

Locations

GB (1)