Nutritional Enhancement in COPD: Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Lung function decline
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is characterized by increased oxidative stress which aggravates airway and systemic inflammation. Previous studies suggested that dietary factors such as ample consumption of antioxidants might have beneficial effects in lung function in COPD patients.
The investigators' primary aim is therefore to investigate prospectively whether a nutritional intervention consisted of diet rich in antioxidants such as fresh fruits and vegetables, would significantly affect lung function decline in COPD patients compared to a free diet.
Methods: This is a 3-year prospective study, incorporating a run-in period of six months and outpatient clinic visits, scheduled every 6 months. Consecutive sampling was used to recruit 120 patients with COPD. At baseline and at each visit all patients were evaluated for respiratory symptoms, dietary habits, medication used and pulmonary function. Patients will be randomized either to a diet based on increased consumption of foods containing antioxidants (fresh fruits and vegetables), intervention group (IG) or, to a free diet, control group (CG).
The investigators hypothesize that the results from the study will suggest that a diet rich in antioxidants may be associated with improvement in lung function in COPD patients. In this respect dietary interventions should be considered in the management of 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
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD according to the GOLD definition*
- •Ability to perform spirometry.
- •(*Pauwels RA, Buist AS, Calverley PM, et al. Global strategy for the diagnosis, management and prevention of Chronic Obstructive Pulmonary disease. NHLBI/WHO Global initiative for Chronic Obstructive Lung Disease (GOLD). Workshop summary. Am J Respir Crit Care Med 2001; 163(5):1256-1276.)
排除标准
- •A history of lung cancer, bronchial asthma or other respiratory disease
- •Continuous use of systemic steroids more than 30 days prior was used as exclusion criteria
研究组 & 干预措施
1
Free diet
Diet rich in antioxidants
Diet with increased consumption of foods containing antioxidants such as fresh fruits, fruit juices and vegetables. Patients in this arm will be seen regularly in the outpatient clinic where there will be informed for the potential beneficial effects of fruits and vegetables in health status by two members of the study team (attending physician and specialist nurse). At baseline and at each visit it is clearly explained to them that the dietary goal is to increase fresh fruit /fruit juices/vegetable consumption of at least one portion per day compared to baseline and to maintain this regime throughout the 3-year study period.
干预措施: Diet rich in antioxidants (Dietary Supplement)
结局指标
主要结局
Lung function decline
时间窗: 3 years
次要结局
未报告次要终点