NCT03159273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

November 11, 2015

Last Update Submit

May 22, 2018

Conditions

Airway Disease

Keywords

Dietary nitrate supplementationCold symptomsStressImmunityExhaled nitric oxideLung functionCardiovascular activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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 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)

    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 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);

Study Arms (2)

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.

Dietary Supplement: Beetroot Juice Group

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.

Interventions

Beetroot Juice GroupDIETARY_SUPPLEMENT

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

Also known as: Beet-It Sport Beet Juice Shot
Beetroot Juice Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Lung healthy or physician diagnosis of asthma
  • Undergraduate student with at least 3 final examinations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75206, United States

Location

Related Publications (1)

  • 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.

    PMID: 30682333DERIVED

Study Officials

  • Thomas Ritz, Ph.D.

    Southern Methodist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 11, 2015

First Posted

May 18, 2017

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations

US(1)