NCT02027415

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

10 months

First QC Date

December 16, 2013

Last Update Submit

December 11, 2017

Conditions

Keywords

air pollutionfoodnitritesnitratesbreath tests/methods

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

EXPERIMENTAL

Beet juice will be given prior to the first car ride and orange juice will be given prior to the second car ride.

Dietary Supplement: Beet juiceDietary Supplement: Orange juice

Orange Beet

EXPERIMENTAL

Orange juice will be given before the first car ride and beet juice will be given before the second car ride.

Dietary Supplement: Beet juiceDietary Supplement: Orange juice

Interventions

Beet juiceDIETARY_SUPPLEMENT

2 cups of beet juice will be given before the car ride

Beet OrangeOrange Beet
Orange juiceDIETARY_SUPPLEMENT

2 cups of orange juice will be given before the car ride

Beet OrangeOrange Beet

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 20190650BACKGROUND
  • 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.

    PMID: 23001278BACKGROUND
  • 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.

    PMID: 20716291BACKGROUND

Study Officials

  • Howard Kipen, MD

    Rutgers RWJMS

    PRINCIPAL INVESTIGATOR

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

Locations