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临床试验/NCT02027415
NCT02027415已完成不适用

Effects of Oral Nitrate Supplementation on Vascular and Pulmonary Oxidative Stress Markers Following Traffic Pollution Exposure

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change in plasma nitrite concentration

研究概览

简要总结

The study hypothesis is that drinking different juices will affect the body's responses to air pollution. Subjects will be exposed to air pollution during a 2-hour car ride on the NJ (New Jersey) Turnpike. Each subject will be asked to do this twice. Before one car ride, the subject will be asked to drink orange juice. Before the other car ride, the subject will be asked to drink beet juice. Samples of blood and exhaled breath will be collected before, immediately after, and 24 hours after each car ride. Levels of nitrites/nitrates will be measured in the blood and breath.

详细描述

Subjects will participate in two exposure sessions. The air pollution exposure consists of a 2-hour car ride along the NJ Turnpike. Samples will be collected at 3 time points for each exposure session: pre-exposure, immediately post-exposure, and 24 hours post-exposure. Blood samples will be collected immediately before and after a 5-minute occlusion at each time point. The subject will also be asked to provide samples of exhaled breath and complete symptom and stress questionnaires at each time point.

Blood samples will be analyzed for serum nitrite. Exhaled breath samples will be analyzed for nitrates and nitrites.

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
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Must live within 20 miles of Piscataway, NJ

排除标准

  • • Are a current smoker
  • Are pregnant or breastfeeding
  • Are HIV-positive
  • Have an active medical condition such as high blood pressure, asthma, diabetes or other serious disease
  • Have a heart condition such as atrial flutter, atrial fibrillation or a pacemaker
  • Are unable to ride comfortably in a car for 2 hours
  • Travel to the EOHSI (Environmental and Occupational Health Sciences Institute) Clinic Center on major highways for more than 3 miles (the Garden State Parkway, the New Jersey Turnpike, Routes 287, 1, 18, or 9).

研究组 & 干预措施

Orange Beet

Experimental

Orange juice will be given before the first car ride and beet juice will be given before the second car ride.

干预措施: Beet juice (Dietary Supplement)

Beet Orange

Experimental

Beet juice will be given prior to the first car ride and orange juice will be given prior to the second car ride.

干预措施: Beet juice (Dietary Supplement)

Beet Orange

Experimental

Beet juice will be given prior to the first car ride and orange juice will be given prior to the second car ride.

干预措施: Orange juice (Dietary Supplement)

Orange Beet

Experimental

Orange juice will be given before the first car ride and beet juice will be given before the second car ride.

干预措施: Orange juice (Dietary Supplement)

结局指标

主要结局

Change in plasma nitrite concentration

时间窗: Prior to the car ride, immediately after the 2-hour car ride, and 24 hours later

Change in plasma nitrite concentration pre- and post-occlusion

次要结局

  • Change in nitrite/nitrate concentration in exhaled breath(Prior to the car ride, immediately after the 2 hour car ride and 24 hours later)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Howard M. Kipen, MD, MPH

Professor and Department Chair

Rutgers, The State University of New Jersey

研究点 (2)

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