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Completed

NCT Number: NCT00435708

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University Belfast

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5 portions fruit and vegetables/day

Behavioral

Participants consume > = 5 portions fruit and veg per day

Primary outcomes

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

    Time frame: 12 weeks

    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;

  2. Markers of Airway Inflammation in Induced Sputum - Sputum 8-isoprostane

    Time frame: 12 Weeks

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

Secondary outcomes

  1. Biochemical Markers of Nutritional Status Plasma Vitamin C

    Time frame: 12 weeks

    Plasma vitamin C concentration umol/L

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Registry information

Official study title

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

Acronym: DISCO

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 15, 2007
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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