The Effect of Juice Types on the Responses to Air Pollution

Air Pollution Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027415
• Other study ID #: Pro2013003273
• 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
• 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).

Related Conditions & MeSH terms

• Air Pollution

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