Obesity & Asthma: Nutrigenetic Response to Omega-3 Fatty Acids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 3
- 主要终点
- Asthma Control Questionnaire (Juniper)
研究概览
简要总结
This project will assess the effectiveness of omega-3 fatty acid supplementation in controlling asthma symptoms among obese asthmatics, and will assess if a person's genes influence response to treatment (personalized medicine). This project may improve our ability to treat asthma and our understanding of the link between obesity and asthma.
详细描述
Obesity increases the risk for asthma diagnosis in children and adults. With obesity on the rise, a better understanding of this association may become critically important to public health. We will determine the impact of fish oil-derived Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) on asthma control among obese asthmatics. These omega-3 fatty acids have been shown to: reduce inflammation important to asthma and improve asthma outcomes in an inconsistent manner across previous smaller studies - results that are consistent with a pharmacogenetic influence. There exists evidence that omega-3 fatty acid response displays a pharmacogenetic response related to ALOX5 genotype. Preliminary data suggests that obese individuals are at greater risk for possessing this same ALOX5 variant and thus obese asthmatics may be more responsive to fish oil. We will determine (in a sub-aim) if there exists an ALOX5 genotype-related response effect with fish oil. This will be the largest clinical trial of omega-3 fatty acid for the treatment of asthma, and the first applying pharmacogenetic/nutrigenetic analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 12-25
- •BMI > 25 (age 18-25) or BMI%>85th (age 12-17) (BMI Liberalized)
- •Physician diagnosis of persistent asthma
- •Lung function responsiveness by bronchodilator reversibility or bronchoprovocation testing
排除标准
- •pregnancy
- •currently taking LTRA for asthma control
- •other serious chronic medical condition
- •bleeding diathesis
研究组 & 干预措施
omega-3 fatty acids
3 softgels (EPA, DHA) twice daily
干预措施: omega-3 polyunsaturated fatty acids (Dietary Supplement)
control
Soybean oil: 3 matched softgel caps twice daily
干预措施: Omega-3 Fatty Acid (Drug)
结局指标
主要结局
Asthma Control Questionnaire (Juniper)
时间窗: baseline, 3 months, 6 months
The ACQ ranges from 0 to 6 (higher values indicate worse asthma control). A score greater than 1.25 in children is considered poor asthma control, and a change of 0.4 or greater is considered clinical meaningful.
次要结局
- N3-to-n6 PUFA Ratio (Granulocytes)(Baseline, 3 and 6 months)
- N3-to-n6 PUFA Ratio (Monocytes)(Baseline, 3 months, 6 months)
- Asthma Control Test(Baseline, 3 months, 6 months)
- Urinary Leukotriene-E4(Baseline, 3 months, 6 months)
- FEV1(Baseline, 3 months, 6 months)
- Exacerbations(6 months)
- Phone Contacts(6 months)