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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02027415
Other study ID # Pro2013003273
Secondary ID
Status Completed
Phase N/A
First received December 16, 2013
Last updated December 11, 2017
Start date December 2013
Est. completion date October 2014

Study information

Verified date December 2017
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Beet juice
2 cups of beet juice will be given before the car ride
Orange juice
2 cups of orange juice will be given before the car ride

Locations

Country Name City State
United States Environmental and Occupational Health Sciences Institute Piscataway New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in plasma nitrite concentration Change in plasma nitrite concentration pre- and post-occlusion Prior to the car ride, immediately after the 2-hour car ride, and 24 hours later
Secondary Change in nitrite/nitrate concentration in exhaled breath Change in nitrite/nitrate concentration in exhaled breath Prior to the car ride, immediately after the 2 hour car ride and 24 hours later
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