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The Effect of Juice Types on the Responses to Air Pollution

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Howard M. Kipen, MD, MPH, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT02027415
First received: December 16, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Air Pollution
Dietary Supplement: Beet juice
Dietary Supplement: Orange juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Oral Nitrate Supplementation on Vascular and Pulmonary Oxidative Stress Markers Following Traffic Pollution Exposure

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Change in plasma nitrite concentration [ Time Frame: Prior to the car ride, immediately after the 2-hour car ride, and 24 hours later ] [ Designated as safety issue: No ]
    Change in plasma nitrite concentration pre- and post-occlusion


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change in nitrite/nitrate concentration in exhaled breath


Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: Beet juice
2 cups of beet juice will be given before the car ride
Dietary Supplement: Orange juice
2 cups of orange juice will be given before the car ride
Experimental: Orange Beet
Orange juice will be given before the first car ride and beet juice will be given before the second car ride.
Dietary Supplement: Beet juice
2 cups of beet juice will be given before the car ride
Dietary Supplement: Orange juice
2 cups of orange juice will be given before the car ride

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027415

Contacts
Contact: Kathy Black, PhD 848-445-6049 kgblack@eohsi.rutgers.edu
Contact: Clarimel Cepeda, BS 848-445-6086 ccepeda@eohsi.rutgers.edu

Locations
United States, New Jersey
Environmental and Occupational Health Sciences Institute Recruiting
Piscataway, New Jersey, United States, 08854
Contact: Kathy Black, PhD    848-445-6049    kgblack@eohsi.rutgers.edu   
Contact: Clarimel Cepeda, BS    848-445-6086    ccepeda@eoshi.rutgers.edu   
Sub-Investigator: ZhiHua Fan, PhD         
Sub-Investigator: Robert Laumbach, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Howard Kipen, MD Rutgers RWJMS