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Nitrate Supplementation During Final Examination Stress

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Southern Methodist University

Status

Completed

Conditions

Airway Disease

Treatments

Dietary Supplement: Beetroot Juice Group

Study type

Interventional

Funder types

Other

Identifiers

NCT03159273
2014_012_RITT

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

76 participants in 2 patient groups

Beetroot Juice Group
Experimental group
Description:
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.
Treatment:
Dietary Supplement: Beetroot Juice Group
Control
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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