Beetroot Juice for Boosting Immunity During a Time of Stress.

The purpose of the present study is to explore the effects of a dietary nitrate supplement (i.e., beetroot juice) on nitric oxide levels, immunity, mood, and cardiovascular activity during and following final exam stress in healthy individuals.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Beetroot Juice; Dietary supplement: Placebo Control

Detailed Description

Research has demonstrated that during times of high stress (i.e., during final exam period), there is a decrease in fraction of exhaled nitric oxide (FeNO) in healthy undergraduate students. Additionally, a separate line of research has demonstrated periods of high stress impact immunity and the cardiovascular system. Nitric oxide may have a benefit in improving the physiological and psychological consequences of stress.

The present research aims to explore the impact of a dietary supplement (beetroot juice drink) on immunity, nitric oxide levels, cardiovascular activity, and mood during and following final exam stress. In this study, investigators monitor changes in cold symptoms, IL-8, blood pressure, airway nitric oxide, and mood in students during the time of final exams and a comparable time of low stress during the term. There are three laboratory assessment visits, as well as a brief questionnaire on a separate day. During the final exam period, half of the participants are randomly assigned to the experimental group provided with a dietary supplement (beetroot juice drink) of which they are asked to take two doses every day (one in the morning and one in the evening) for seven days. The other half of the participants are randomly assigned to the placebo control group provided with a placebo supplement (placebo drink) of which they are asked to take two doses every day (one in the morning and one in the evening for seven days). For the final exam period, the first of the two sessions takes place early in the examination period (first half), and the second assessment takes place in the later exam period (second half). The online questionnaire assessing symptoms is measured 3 days after the final examination period.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75205
      • Southern Methodist University
    • Waco, Texas, United States, 76798
      • Annie T. Ginty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Currently enrolled at Baylor University or Southern Methodist University

Exclusion Criteria:

• Current smoker
• Clinically significant asthma, COPD, Emphysema, heart disease, cerebrovascular disease, thyroid dysfunction, out of control diabetes
• Pregnancy, diagnosis of schizophrenia, psychosis, mood disorder, psychosis, drug or alcohol dependance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beetroot Juice; Participants in this group are given 7 daily doses of a dietary nitrate supplement (Beet-it Sport beetroot juice shots, ) and asked to drink two doses daily during the week of their final academic examinations of that term in college.	Dietary supplement: Beetroot Juice; Beet-It Sports Shot, 70mL, containing 6.5 mmol nitric oxide (taking two shots per day in active group)
Placebo Comparator: Placebo Control; Participants in this group are given 7 daily doses of a placebo matched in appearance and taste (Beet-it Sport placebo juice shots) and asked to drink two doses daily during the week of their final academic examinations of that term in college.	Dietary supplement: Placebo Control; Beet-It Placebo Shot, 70mL (taking two shots per day in placebo group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wisconsin Upper Respiratory Symptom Survey (WURSS)	Assesses symptoms of acute upper respiratory tract infections (common cold symptoms) by questionnaire	Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period), 1-3 days after finishing beetroot shots (after final examinations)
Changes in IL-8 levels	Change in IL-8 levels	Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled Nitric Oxide	The Fraction of NO in Exhaled Breath (FENO, in ppb) will be measured with an electrochemical gas analyzer (NIOX vero).	Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
Resting blood pressure	Resting blood pressure (systolic and diastolic)	Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
Acute stress	Perceived Stress Scale	Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
Change in negative affect	PANAS negative affect scale	Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
Adherence monitoring (feasibility )	Participants will upload a cell phone video of their intake for that day to a secure cloud folder, time stamp in comparison to assigned intake windows provides measure of adherence	Every day, twice a day during active beetroot
Change in depressive symptomology	Hospital Anxiety and Depression Scale	Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)

Collaborators and Investigators

• Sponsor: Baylor University
• Collaborators: Southern Methodist University

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1866308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No