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Nitrate Supplementation During Final Examination Stress

Not Applicable
Completed
Conditions
Airway Disease
Interventions
Dietary Supplement: Beetroot Juice Group
Registration Number
NCT03159273
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
76
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Beetroot Juice GroupBeetroot Juice GroupSubjects 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.
Primary Outcome Measures
NameTimeMethod
Change in Cold SymptomsNon-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
NameTimeMethod
Change in Negative AffectNon-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

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

Change in Blood PressureNon-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

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

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

Trial Locations

Locations (1)

Southern Methodist University

🇺🇸

Dallas, Texas, United States

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