Nitrate Supplementation During Final Examination Stress

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

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.

Study Overview

• Status: Completed
• Conditions: Airway Disease
• Intervention / Treatment: Dietary supplement: Beetroot Juice Group

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75206
      • Southern Methodist University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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);

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Stress; Immunity; Lung function; Exhaled nitric oxide; Dietary nitrate supplementation; Cold symptoms; Cardiovascular activity
• Other Study ID Numbers: 2014_012_RITT