Randomized Controlled Trial of Marine Lipid Fraction PCSO-524™ on Airway Inflammation and Hyperpnea-Induced Bronchoconstriction in Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pulmonary Function (Percent Change in FEV1, measured in Liters)
研究概览
简要总结
The primary aim of this study will be to evaluate the effects of Lyprinol® supplementation on airway inflammation and the bronchoconstrictor response to dry air hyperpnea in individuals with asthma. The investigators hypothesize that Lyprinol® supplementation, compared to placebo, will significantly attenuate airway inflammation and hyperpnea-induced bronchoconstriction in asthmatic individuals.
详细描述
Our research group has shown, on numerous occasions that fish oil has a markedly protective effect in suppressing airway inflammation and exercise-induced bronchoconstriction in elite athletes and asthmatic individuals. Purified fish oil and the marine lipid fraction PCSO-524™ (Lyprinol™) have both been used in supplementation studies in asthma [2, 10, 11]. While fish oil is a rich source of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), Lyprinol® is a patented extract of stabilized lipids from the New Zealand green-lipped mussel, Perna canaliculus, combined with olive oil and vitamin E. EPA and DHA are the main ingredients of fish oil, and thus there will be similarities between Lyprinol and fish oil in terms of mechanism of action. Thus, we are aiming to show that Lyprinol® can modulate these inflammatory eicosanoids to exert anti-inflammatory effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with asthma and EIB. Evidence of a diagnosis of asthma will include medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma. For the diagnosis of EIB, subjects must demonstrate a fall in FEV1 of ≥ 10% after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge; FEV1 is a measure of lung function
- •Not currently be taking any fish oil supplements
- •Limit their fish consumption to 1 fish meal per week during the course of the study
排除标准
- •Severe asthma is indicated. These subjects will be identified by a post-EVH drop in FEV1 that is greater than 50% during their first lab testing session or will have a history of severe asthma-related events such as hospitalizations or emergency room visits. Only mild to moderate asthmatics (i.e. subjects whose FEV1 drops by 10-50%) will be included in this study.
- •They taking currently taking asthma maintenance medications
- •They are pregnant
- •They have a history of hyperlipidemia (high cholesterol), hypertension, diabetes, bleeding disorder, delayed clotting time, or seizure disorder
- •They are allergic to shellfish, fish, corn, or soy products
研究组 & 干预措施
Olive Oil Capsule
Ten subjects will take eight placebo olive oil capsules per day for three weeks.
干预措施: Placebo (Olive Oil) (Dietary Supplement)
Lyprinol
Ten subjects will take eight Lyprinol capsules per day for three weeks.
干预措施: Lyprinol (Dietary Supplement)
结局指标
主要结局
Pulmonary Function (Percent Change in FEV1, measured in Liters)
时间窗: 8 weeks
The percent change in FEV1 is the percent change in the volume of air exhaled during the first second of a forced exhalation as measured before and after the surrogate exercise challenge.
次要结局
- Fraction of Exhaled Nitric Oxide(8 weeks)