A Pilot Study of the Effectiveness of a High Omega-3/Low Omega-6 Treatment Diet for Treating Aspirin-exacerbated Respiratory Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in urinary leukotriene E4 levels
研究概览
简要总结
The purpose of this trial is to test the hypothesis that a treatment diet low in omega-6 fatty acids and high in omega-3 fatty acids can cause improvement in asthma symptoms, nasal symptoms, and pulmonary function in patients with aspirin-exacerbated respiratory disease (AERD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of physician-diagnosed asthma
- •History of nasal polyposis
- •History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or diagnosis of AERD via a physician-conducted challenge to aspirin
- •Age between 18 and 70 years
排除标准
- •Current smoking, defined as daily tobacco smoking in the last 6 months and at least one instance of tobacco smoking in the last 3 months.
- •Current pregnancy or breastfeeding
- •History of allergy to fish or any unwillingness to eat fish as a regular part of the diet
- •Use of Zyflo (zileuton) in the last two weeks
- •Presence of an implantable cardioverter-defibrillator
- •Use of oral steroids in the last two weeks
- •Participation in any other clinical trial in the last month
- •Any use of nonsteroidal antiinflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme during the course of the study
研究组 & 干预措施
Normal diet
Two weeks of unaltered diet
Low omega-6/high omega-3 diet
Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams
干预措施: Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams (Behavioral)
结局指标
主要结局
Change in urinary leukotriene E4 levels
时间窗: 2 weeks and 4 weeks
Change in serum leukotriene B4 levels
时间窗: 2 weeks and 4 weeks
次要结局
- Change in Sino-Nasal Outcome Test-22 (SNOT-22) score(Baseline, 2 weeks, and 4 weeks)
- Change in asthma control questionnaire score(Baseline, 2 weeks, and 4 weeks)
- Change in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC(Baseline, two weeks, and four weeks)
研究者
Tanya Laidlaw, MD
Assistant Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital