Clinical trial NCT03159273: Nitrate Supplementation During Final Examination Stress
Official title: Dietary Supplementation of Nitrate by Beetroot Juice to Boost Immunity, Mood, Cardiovascular Function During Academic Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Disease
Keywords: Dietary nitrate supplementation
Cold symptoms
Stress
Immunity
Exhaled nitric oxide
Lung function
Cardiovascular activity
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in Cold Symptoms
timeFrame: 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 outcomes:
measure: Change in Fraction of Exhaled Nitric Oxide (FeNO)
timeFrame: 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);
measure: Change in Blood Pressure
timeFrame: 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);
measure: Change in Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 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);
measure: Change in Peak Expiratory Flow (PEF)
timeFrame: 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);
measure: Change in Negative Affect
timeFrame: 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);
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
affiliation: Southern Methodist University
name: Thomas Ritz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ritz T, Werchan CA, Kroll JL, Rosenfield D. Beetroot juice supplementation for the prevention of cold symptoms associated with stress: A proof-of-concept study. Physiol Behav. 2019 Apr 1;202:45-51. doi: 10.1016/j.physbeh.2019.01.015. Epub 2019 Jan 22.