Beetroot Juice for Boosting Immunity During a Time of Stress.

Healthy Clinical Trial

Official title:

Beetroot Juice for Boosting Immunity During a Time of Stress.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06434181
• Other study ID #: 1866308
• Status: Completed
• Phase: Phase 2
• Start date: April 11, 2022
• Est. completion date: December 13, 2022

Study information

• Verified date: May 2024
• Source: Baylor 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 (i.e., beetroot juice) on nitric oxide levels, immunity, mood, and cardiovascular activity during and following final exam stress in healthy individuals.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Beetroot Juice
Beet-It Sports Shot, 70mL, containing 6.5 mmol nitric oxide (taking two shots per day in active group)
• Placebo Control
Beet-It Placebo Shot, 70mL (taking two shots per day in placebo group)

Locations

Country	Name	City	State
United States	Southern Methodist University	Dallas	Texas
United States	Annie T. Ginty	Waco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor University	Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

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