Effects of Fish Oil in Alleviating Health Hazards Associated With Ozone Exposure
赞助:
Fudan University
合作者:
信息的提供 (责任方):
Haidong Kan，Fudan University
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 30, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | September 20, 2018 | ||
| 预计主要完成日期 | November 11, 2018 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Changes of FEV1[ Time Frame: 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 Changes of FVC[ Time Frame: 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 |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Effects of Fish Oil in Alleviating Health Hazards Associated With Ozone Exposure | ||
| 正式标题 ICMJE | Effects of Fish Oil in Alleviating Cardiopulmonary Hazards Associated With Ozone Exposure in Young Healthy Adults | ||
| 简要概况 | This study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary effects induced by ozone exposure. |
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| 详细说明 | 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. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Factorial Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Prevention |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Enrolling by invitation | ||
| 预计入组 ICMJE |
64 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 30, 2019 | ||
| 预计主要完成日期 | November 11, 2018 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - 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. Exclusion Criteria: - 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). | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：30 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Haidong Kan，Fudan University | ||
| 研究赞助商 ICMJE | Fudan University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Fudan University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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