Clinical trial NCT02027415: The Effect of Juice Types on the Responses to Air Pollution
Official title: Effects of Oral Nitrate Supplementation on Vascular and Pulmonary Oxidative Stress Markers Following Traffic Pollution Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Air Pollution
Keywords: air pollution
food
nitrites
nitrates
breath tests/methods
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Must live within 20 miles of Piscataway, NJ

Exclusion Criteria:

* • 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).

Primary outcomes:
measure: Change in plasma nitrite concentration
timeFrame: Prior to the car ride, immediately after the 2-hour car ride, and 24 hours later
Secondary outcomes:
measure: Change in nitrite/nitrate concentration in exhaled breath
timeFrame: Prior to the car ride, immediately after the 2 hour car ride and 24 hours later
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Environmental and Occupational Health Sciences Institute
state: New Jersey
Study officials:
affiliation: Rutgers RWJMS
name: Howard Kipen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laumbach RJ, Rich DQ, Gandhi S, Amorosa L, Schneider S, Zhang J, Ohman-Strickland P, Gong J, Lelyanov O, Kipen HM. Acute changes in heart rate variability in subjects with diabetes following a highway traffic exposure. J Occup Environ Med. 2010 Mar;52(3):324-31. doi: 10.1097/JOM.0b013e3181d241fa.
citation: Hussain S, Laumbach R, Coleman J, Youssef H, Kelly-McNeil K, Ohman-Strickland P, Zhang J, Kipen H. Controlled exposure to diesel exhaust causes increased nitrite in exhaled breath condensate among subjects with asthma. J Occup Environ Med. 2012 Oct;54(10):1186-91. doi: 10.1097/JOM.0b013e31826bb64c.
citation: Laumbach RJ, Kipen HM. Acute effects of motor vehicle traffic-related air pollution exposures on measures of oxidative stress in human airways. Ann N Y Acad Sci. 2010 Aug;1203:107-12. doi: 10.1111/j.1749-6632.2010.05604.x.