Effects of Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Ozone Exposure in Young Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Changes of FVC
研究概览
简要总结
This study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary effects induced by ozone exposure.
详细描述
The investigators will conduct a randomized controlled trial among 64 healthy young adults in Shanghai, China. The eligible participants will be randomly assigned in a 2*2 factorial design to 1 of 4 groups: 1) fish oil and ozone exposure, 2) fish oil and shame exposure, 3) soy oil and ozone exposure, or 4) soy oil and shame exposure. The participants who take fish oil would receive 2.2 g/day (two 1.1-g capsules daily) in divided doses, and other participants will take the same amount of soy oil capsules. Two hour ozone exposure (200 ppb ozone) or shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation. Ozone is generated by a silent electric discharge method (HTU-500, AZCO Industries Ltd., Canada) and introduced into the chamber. The temperature and relative humidity in the chamber are maintained at 22±1℃ and 50%±5%, respectively. During the 2-hour exposure, each subject alternate 15 minutes of exercise on a treadmill and 15 minutes of rest. The exercise workload would be adjusted to achieve the targeted ventilation of 20±1 L/min/m2 body surface area. Health examinations will be conducted immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Living in Shanghai during study period;
- •Ability to complete the training exercise to induce an inspired ventilation rate of 20±1 L/min/m2 body surface area;
- •Body mass index >18.5 and ≤30 (30 is the lower limit for class 2 obesity for Chinese);
- •Taking the fish oil or placebo on time.
排除标准
- •Being allergic to seafood;
- •Smoking and alcohol abuse;
- •Current drug and dietary supplements intake;
- •Subjects with allergic disease, such as allergic rhinitis, allergic asthma, and atopy;
- •Subjects with cardiovascular disease, such as congenital heart disease, pulmonary heart disease, and hypertension;
- •Subjects with respiratory disease, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
- •Subjects with chronic disease, such as diabetes, chronic hepatitis, and kidney disease;
- •Subjects with a history of major surgery;
- •Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
- •Abnormal baseline 12-lead resting electrocardiogram;
- •Abnormal blood index, such as cell counting, blood lipids, and glutamic-pyruvic transaminase (GPT).
结局指标
主要结局
Changes of FVC
时间窗: FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning
Changes of forced vital capacity
Changes of FEV1
时间窗: FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning
Changes of forced expiratory volume in 1 second
次要结局
未报告次要终点
研究者
Haidong Kan
PhD and Professor
Fudan University