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Completed

NCT Number: NCT06434181

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southern Methodist University, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beetroot juice

Dietary Supplement

Beet-It Sports Shot, 70mL, containing 6.5 mmol nitric oxide (taking two shots per day in active group)

Placebo Control

Dietary Supplement

Beet-It Placebo Shot, 70mL (taking two shots per day in placebo group)

Primary outcomes

  1. Wisconsin Upper Respiratory Symptom Survey (WURSS)

    Time frame: 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)

    Assesses symptoms of acute upper respiratory tract infections (common cold symptoms) by questionnaire

  2. Changes in IL-8 levels

    Time frame: 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 IL-8 levels

Secondary outcomes

  1. Resting blood pressure

    Time frame: 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 (systolic and diastolic)

  2. Acute stress

    Time frame: 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)

    Perceived Stress Scale

  3. Change in negative affect

    Time frame: 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)

    PANAS negative affect scale

  4. Adherence monitoring (feasibility )

    Time frame: Every day, twice a day during active beetroot

    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

  5. Exhaled Nitric Oxide

    Time frame: 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)

    The Fraction of NO in Exhaled Breath (FENO, in ppb) will be measured with an electrochemical gas analyzer (NIOX vero).

  6. Change in depressive symptomology

    Time frame: 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)

    Hospital Anxiety and Depression Scale

Sponsors and collaborators

Lead sponsor

Baylor University

Other

Collaborators

  • Southern Methodist University

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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