Nitrate Supplementation During Final Examination Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dietary Supplementation of Nitrate by Beetroot Juice to Boost Immunity, Mood, Cardiovascular Function During Academic Stress

Conditions
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Airway Disease

Intervention / Treatment
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* Dietary Supplement: Beetroot Juice Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beetroot Juice Group<br>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<br>* Beetroot juice drink- 7 daily doses (70 ml, containing 0.4-0.5 mg nitrate) taken over a week<br>* Other names: Beet-It Sport Beet Juice Shot;|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cold Symptoms | Changes in participant-reported 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fraction of Exhaled Nitric Oxide (FeNO) | Changes in participant's measured level of nitric oxide in exhaled air | 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 Blood Pressure | Change in participant's measured systolic and diastolic 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 Forced Expiratory Volume in 1 second (FEV1) | Change in participant's measured FEV1 using a handheld spirometer | 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 Peak Expiratory Flow (PEF) | Change in participant's measured PEF using a handheld spirometer | 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 Negative Affect | PANAS negative affect scale | 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); | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary nitrate supplementation, Cold symptoms, Stress, Immunity, Exhaled nitric oxide, Lung function, Cardiovascular activity