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Clinical Trials/NCT03159273
NCT03159273CompletedNot Applicable

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

Southern Methodist University1 site in 1 country76 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
1
Primary Endpoint
Change in Cold Symptoms

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
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
  • •Any kind of lung disease (other than asthma)
  • •Corticosteroids within the past month
  • •Antibiotics within the past month

Arms & Interventions

Beetroot Juice Group

Experimental

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.

Intervention: Beetroot Juice Group (Dietary Supplement)

Control

No Intervention

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.

Outcomes

Primary Outcomes

Change in Cold Symptoms

Time Frame: 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 Outcomes

  • 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);)
  • 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 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 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);)
  • 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);)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Ritz

Professor

Southern Methodist University

Study Sites (1)

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