The Effect of Juice Types on the Responses to Air Pollution

December 11, 2017 updated by: Howard M. Kipen, MD, MPH, Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Environmental and Occupational Health Sciences Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
2 cups of beet juice will be given before the car ride
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.
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
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 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
Change in nitrite/nitrate concentration in exhaled breath
Prior to the car ride, immediately after the 2 hour car ride and 24 hours later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Howard Kipen, MD, Rutgers RWJMS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

January 2, 2014

First Posted (ESTIMATE)

January 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

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.

Clinical Trials on Air Pollution

Clinical Trials on Beet juice

3
Subscribe