Air PollutionNCT02027415
The Effect of Juice Types on the Responses to Air Pollution
A study testing Beet juice and Orange juice in people with Air Pollution, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Air Pollution
- What is being tested?
- Beet juice and Orange juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Must live within 20 miles of Piscataway, NJ
Who cannot join
- • 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Environmental and Occupational Health Sciences Institute
Piscataway, New Jersey, 08854
About this study
Official title: 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.
Read the 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.
- Conditions
- Air Pollution
- Being tested
- Beet juice, Orange juice
- Keywords
- air pollution, food, nitrites, nitrates, breath tests/methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beet juiceDietary supplement
2 cups of beet juice will be given before the car ride
Orange juiceDietary supplement
2 cups of orange juice will be given before the car ride
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Beet juice; Dietary 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. Receives: Dietary Supplement: Beet juice; Dietary Supplement: Orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma nitrite concentration
Change in plasma nitrite concentration pre- and post-occlusion
Measured: 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
Change in nitrite/nitrate concentration in exhaled breath
Measured: Prior to the car ride, immediately after the 2 hour car ride and 24 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Air PollutionStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard M. Kipen, MD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Howard Kipen, MD, Principal investigator, Rutgers RWJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027415
- Sponsor's protocol ID
- Pro2013003273
- Status last verified
- Dec 2017
- First submitted
- 16 Dec 2013
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20190650Hussain 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.
PubMed 23001278Laumbach 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.
PubMed 20716291
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Nitrate Supplementation on Vascular and Pulmonary Oxidative Stress Markers Following Traffic Pollution Exposure
- ClinicalTrials.gov ID
- NCT02027415
- Acronym / sponsor ID
- Pro2013003273
- Conditions
- Air Pollution
- Keywords
- air pollution, food, nitrites, nitrates, breath tests/methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beet Orange | Experimental | Dietary Supplement: Beet juice, Dietary Supplement: Orange juiceBeet juice will be given prior to the first car ride and orange juice will be given prior to the second car ride. |
| Orange Beet | Experimental | Dietary Supplement: Beet juice, Dietary Supplement: Orange juiceOrange juice will be given before the first car ride and beet juice will be given before the second car ride. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Must live within 20 miles of Piscataway, NJ
Key exclusion criteria (7 listed)
- • Are a current smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beet juice2 cups of beet juice will be given before the car ride | Dietary supplement | Beet Orange, Orange Beet |
| Orange juice2 cups of orange juice will be given before the car ride | Dietary supplement | Beet Orange, Orange Beet |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Background: PubMed 20190650Laumbach 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.
- Background: PubMed 23001278Hussain 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.
- Background: PubMed 20716291Laumbach 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.
Related trials for Air Pollution
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure
Hypertension, Systolic, Metabolic Syndrome
Active, not recruiting
AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Kipen, MD principal investigator
Rutgers RWJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beet juice and Orange juice in people with Air Pollution, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma nitrite concentration (time frame: Prior to the car ride, immediately after the 2-hour car ride, and 24 hours later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027415, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.