- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027415
The Effect of Juice Types on the Responses to Air Pollution
Effects of Oral Nitrate Supplementation on Vascular and Pulmonary Oxidative Stress Markers Following Traffic Pollution Exposure
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New Jersey
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Piscataway, New Jersey, United States, 08854
- Environmental and Occupational Health Sciences Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Beet Orange
Beet juice will be given prior to the first car ride and orange juice will be given prior to the second car ride.
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2 cups of beet juice will be given before the car ride
2 cups of orange juice will be given before the car ride
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EXPERIMENTAL: Orange Beet
Orange juice will be given before the first car ride and beet juice will be given before the second car ride.
|
2 cups of beet juice will be given before the car ride
2 cups of orange juice will be given before the car ride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma nitrite concentration
Time Frame: Prior to the car ride, immediately after the 2-hour car ride, and 24 hours later
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Change in plasma nitrite concentration pre- and post-occlusion
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Prior to the car ride, immediately after the 2-hour car ride, and 24 hours later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nitrite/nitrate concentration in exhaled breath
Time Frame: Prior to the car ride, immediately after the 2 hour car ride and 24 hours later
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Change in nitrite/nitrate concentration in exhaled breath
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Prior to the car ride, immediately after the 2 hour car ride and 24 hours later
|
Collaborators and Investigators
Investigators
- Principal Investigator: Howard Kipen, MD, Rutgers RWJMS
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro2013003273
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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