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The Effect of Juice Types on the Responses to Air Pollution

NCT ID: NCT02027415

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Air Pollution

Keywords

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air pollution food nitrites nitrates breath tests/methods

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Beet juice

Intervention Type DIETARY_SUPPLEMENT

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

Orange juice

Intervention Type DIETARY_SUPPLEMENT

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

Orange Beet

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

Group Type EXPERIMENTAL

Beet juice

Intervention Type DIETARY_SUPPLEMENT

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

Orange juice

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Beet juice

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

Intervention Type DIETARY_SUPPLEMENT

Orange juice

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Howard M. Kipen, MD, MPH

Professor and Department Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Howard Kipen, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers RWJMS

Locations

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Environmental and Occupational Health Sciences Institute

Piscataway, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20190650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23001278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20716291 (View on PubMed)

Other Identifiers

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Pro2013003273

Identifier Type: -

Identifier Source: org_study_id