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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 13, 2017
December 1, 2017
10 months
December 16, 2013
December 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in nitrite/nitrate concentration in exhaled breath
Prior to the car ride, immediately after the 2 hour car ride and 24 hours later
Study Arms (2)
Beet Orange
EXPERIMENTALBeet juice will be given prior to the first car ride and orange juice will be given prior to the second car ride.
Orange Beet
EXPERIMENTALOrange juice will be given before the first car ride and beet juice will be given before the second car ride.
Interventions
2 cups of beet juice will be given before the car ride
2 cups of orange juice will be given before the car ride
Eligibility Criteria
You may qualify if:
- Healthy
- Must live within 20 miles of Piscataway, NJ
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Environmental and Occupational Health Sciences Institute
Piscataway, New Jersey, 08854, United States
Related Publications (3)
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.
PMID: 20190650BACKGROUNDHussain 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.
PMID: 23001278BACKGROUNDLaumbach 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.
PMID: 20716291BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Kipen, MD
Rutgers RWJMS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Department Chair
Study Record Dates
First Submitted
December 16, 2013
First Posted
January 6, 2014
Study Start
December 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 13, 2017
Record last verified: 2017-12