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临床试验/NCT00435708
NCT00435708已完成不适用

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

Queen's University, Belfast2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
2
主要终点
Self-reported Intake of Fruit and Vegetables (Number of Portions Per Day);

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

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

时间窗: 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;

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

时间窗: 12 Weeks

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

次要结局

  • Biochemical Markers of Nutritional Status Plasma Vitamin C(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle McKinley

Professor

Queen's University, Belfast

研究点 (2)

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