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Nitrate Supplementation During Final Examination Stress

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ClinicalTrials.gov Identifier: NCT03159273
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Ritz, Southern Methodist University

Brief Summary:
The purpose of the present study is to explore the effects of a dietary nitrate supplement on immunity, mood, cardiovascular activity, and lung function during and following final exam stress in both healthy and asthmatic individuals.

Condition or disease Intervention/treatment Phase
Airway Disease Dietary Supplement: Beetroot Juice Group Not Applicable

Detailed Description:

Past research has demonstrated significant changes in immune response and airway inflammation during times of stress. Specifically, significant decreases in the fraction of exhaled nitric oxide (FeNO) in both healthy and asthmatic undergraduate students have been found during times of final exam stress. Additionally, research suggests that dietary supplementation of nitric oxide may have beneficial cardiovascular effects which may offset the physiological consequences of stress.

This research study explores the effects of a dietary supplement on immunity, mood, cardiovascular and respiratory function during and following final exam stress. In this study, investigators monitor changes in respiratory infection incidence, airway nitric oxide, mood, blood pressure, and lung function in students with and without asthma during the time of final exams and a comparable time of low stress during the term. There are three assessments in the laboratory, as well as two additional brief questionnaires on separate days. During the final exam period, half of the participants are randomly assigned to the experimental group which is provided with a dietary supplement (beetroot juice drink) of which they are asked to take one dose every day in the morning for seven days. The three assessments periods include two during the week of final exams and one during a period of low stress scheduled up to two weeks to two months before that time. For the final exam period, the first of the two sessions takes place on the day before the second of these exams, and the second assessment takes place on a subsequent day after second exam. A follow-up assessment of cold symptoms takes place online 7 days after the final exam period.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Dietary Supplementation of Nitrate by Beetroot Juice to Boost Immunity, Mood, Cardiovascular Function During Academic Stress
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Beetroot Juice Group
Subjects in this group are given 7 daily doses of a dietary nitrate supplement (Beet-it Sport beetroot juice shots) and asked to drink one dose daily during the week of their final academic examinations of that term in college.
Dietary Supplement: Beetroot Juice Group
Beetroot juice drink- 7 daily doses (70 ml, containing 0.4-0.5 mg nitrate) taken over a week
Other Name: Beet-It Sport Beet Juice Shot

No Intervention: Control
Subjects in this group are not given a dietary nitrate supplement but are assessed at the same time points as those in the experimental group.



Primary Outcome Measures :
  1. Change in Cold Symptoms [ Time Frame: Non-stress assessment 2 weeks to 2 months before final exams, 2 assessments during the week of final exams (once the day before participants' 2nd final exam, and second on a day between 2nd and last exam); and 1 week post-exams ]
    Changes in participant-reported cold symptoms


Secondary Outcome Measures :
  1. Change in Fraction of Exhaled Nitric Oxide (FeNO) [ Time Frame: Non-stress assessment 2 weeks to 2 months before final exams, 2 assessments during the week of final exams (once the day before participants' 2nd final exam, and second on a day between 2nd and last exam); ]
    Changes in participant's measured level of nitric oxide in exhaled air

  2. Change in Blood Pressure [ Time Frame: Non-stress assessment 2 weeks to 2 months before final exams, 2 assessments during the week of final exams (once the day before participants' 2nd final exam, and second on a day between 2nd and last exam); ]
    Change in participant's measured systolic and diastolic blood pressure

  3. Change in Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Non-stress assessment 2 weeks to 2 months before final exams, 2 assessments during the week of final exams (once the day before participants' 2nd final exam, and second on a day between 2nd and last exam); ]
    Change in participant's measured FEV1 using a handheld spirometer

  4. Change in Peak Expiratory Flow (PEF) [ Time Frame: Non-stress assessment 2 weeks to 2 months before final exams, 2 assessments during the week of final exams (once the day before participants' 2nd final exam, and second on a day between 2nd and last exam); ]
    Change in participant's measured PEF using a handheld spirometer

  5. Change in Negative Affect [ Time Frame: Non-stress assessment 2 weeks to 2 months before final exams, 2 assessments during the week of final exams (once the day before participants' 2nd final exam, and second on a day between 2nd and last exam); ]
    PANAS negative affect scale



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Lung healthy or physician diagnosis of asthma
  • Undergraduate student with at least 3 final examinations

Exclusion Criteria:

  • Current smoker
  • History of seizures
  • History of stroke
  • History of heart attack or heart disease
  • History of thyroid problems
  • History of head injury or neurological disorder
  • Diabetes
  • Any kind of lung disease (other than asthma)
  • Corticosteroids within the past month
  • Antibiotics within the past month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159273


Locations
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United States, Texas
Southern Methodist University
Dallas, Texas, United States, 75206
Sponsors and Collaborators
Southern Methodist University
Investigators
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Principal Investigator: Thomas Ritz, Ph.D. Southern Methodist University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Ritz, Professor, Southern Methodist University
ClinicalTrials.gov Identifier: NCT03159273     History of Changes
Other Study ID Numbers: 2014_012_RITT
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Keywords provided by Thomas Ritz, Southern Methodist University:
Dietary nitrate supplementation
Cold symptoms
Stress
Immunity
Exhaled nitric oxide
Lung function
Cardiovascular activity