Comparative and Additive Effects of Fish Oil and Ascorbic Acid Supplementation on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pulmonary Function
研究概览
简要总结
Combining fish oil and vitamin C supplementation will provide a greater anti-inflammatory effect against developing exercise-induced bronchoconstriction (EIB) than either nutritional supplement alone.
详细描述
The aim of this study is to extend previous findings that nutritional supplementation or dietary modification can ameliorate exercise-induced bronchoconstriction. It has been shown in separate studies that fish oil and ascorbic acid (vitamin C) individually protect against EIB by improving pulmonary function and reducing airway inflammation. The main aim of this study is to determine the comparative and additive effects of fish oil and ascorbic acid supplementation on EIB and airway inflammation in asthmatic individuals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma, based on medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma
- •Diagnosis of EIB, based on ≥10% fall in post-challenge FEV1, a measure of lung function, after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge
- •Not currently taking asthma maintenance medication or physician approval to discontinue current asthma medication for the duration of the study
- •Not currently taking any fish oil or ascorbic acid supplements above the level recommended for adequate intake (if currently taking supplements, can participate if the subject stops taking the supplements for 2 weeks before starting the study and throughout the study)
- •Agree to limit fish consumption to 1 fish meal per week throughout the study
- •Agree to avoid vitamin C-rich foods throughout the study
排除标准
- •Resting FEV1 (the amount of air blown out in the first second of a forced exhalation) <60% of predicted when off medication
- •Pregnancy
- •History of cardiovascular disease, including hyperlipidemia (high cholesterol) and hypertension (high blood pressure)
- •History of bleeding disorders or delayed clotting time
- •History of diabetes
- •History of seizures
- •Allergy to fish oil or ascorbic acid (vitamin C)
研究组 & 干预措施
Active Fish Oil + Vitamin C Placebo
Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks.
干预措施: Ascorbic Acid Placebo (Dietary Supplement)
Fish Oil Placebo + Active Vitamin C
Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks.
干预措施: Fish Oil Placebo (Dietary Supplement)
Active Fish Oil + Active Vitamin C
Following a 2-week washout period, all subjects from the other two arms (n=30) will take 10 active fish oil capsules per day and 2 active vitamin C capsules per day for 3 weeks.
干预措施: Ascorbic Acid (Dietary Supplement)
Active Fish Oil + Active Vitamin C
Following a 2-week washout period, all subjects from the other two arms (n=30) will take 10 active fish oil capsules per day and 2 active vitamin C capsules per day for 3 weeks.
干预措施: Fish Oil (Dietary Supplement)
Fish Oil Placebo + Active Vitamin C
Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks.
干预措施: Ascorbic Acid (Dietary Supplement)
Active Fish Oil + Vitamin C Placebo
Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks.
干预措施: Fish Oil (Dietary Supplement)
结局指标
主要结局
Pulmonary Function
时间窗: 8 weeks
次要结局
- Exhaled nitric oxide to measure airway inflammation(8 weeks)