Nitrate Supplementation During Final Examination Stress

Airway Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159273
• Other study ID #: 2014_012_RITT
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2018
• Source: Southern Methodist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Disease

Intervention

Dietary Supplement:
• Beetroot Juice Group
Beetroot juice drink- 7 daily doses (70 ml, containing 0.4-0.5 mg nitrate) taken over a week

Locations

Country	Name	City	State
United States	Southern Methodist University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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);
Secondary	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);
Secondary	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);
Secondary	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);
Secondary	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);