NCT03159273 - Nitrate Supplementation During Final Examination Stress | Crick

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

76

Conditions

Airway Disease

Interventions

Beetroot Juice GroupDIETARY_SUPPLEMENT

Beetroot juice drink- 7 daily doses (70 ml, containing 0.4-0.5 mg nitrate) taken over a week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Southern Methodist University

Dallas, Texas, United States

Outcomes

Primary Outcomes

Change in Cold Symptoms

Changes in participant-reported 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

Secondary Outcomes

Change in Fraction of Exhaled Nitric Oxide (FeNO)

Changes in participant's measured level of nitric oxide in exhaled air

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);

Change in Blood Pressure

Change in participant's measured systolic and diastolic blood pressure

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);

Change in Forced Expiratory Volume in 1 second (FEV1)

Change in participant's measured FEV1 using a handheld spirometer

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);

Change in Peak Expiratory Flow (PEF)

Change in participant's measured PEF using a handheld spirometer

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);