Nitrate Supplementation During Final Examination Stress

Sponsor
Southern Methodist University (Other)
Overall Status
Completed
CT.gov ID
NCT03159273
Collaborator
(none)
76
1
2
15.9
4.8

Study Details

Study Description

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
  • Dietary Supplement: Beetroot Juice Group
N/A

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.

Study Design

Study Type:
Interventional
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 :
Jan 1, 2014
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Cold Symptoms [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) [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 [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) [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) [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern Methodist University Dallas Texas United States 75206

    Sponsors and Collaborators

    • Southern Methodist University

    Investigators

    • Principal Investigator: Thomas Ritz, Ph.D., Southern Methodist University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Ritz, Professor, Southern Methodist University
    ClinicalTrials.gov Identifier:
    NCT03159273
    Other Study ID Numbers:
    • 2014_012_RITT
    First Posted:
    May 18, 2017
    Last Update Posted:
    May 23, 2018
    Last Verified:
    May 1, 2018
    Keywords provided by Thomas Ritz, Professor, Southern Methodist University

    Study Results

    No Results Posted as of May 23, 2018