## Protocol Section
### Identification Module
**NCT ID:** NCT06434181

**Brief Title:** Beetroot Juice for Boosting Immunity During a Time of Stress.

**Official Title:** Beetroot Juice for Boosting Immunity During a Time of Stress.

#### Organization Study ID Info
**ID:** 1866308
#### Organization
**Class:** OTHER
**Full Name:** Baylor University
### Status Module
#### Completion Date
**Date:** 2022-12-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-12-13

**Type:** ACTUAL

#### Start Date
**Date:** 2022-04-11

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Southern Methodist University

#### Lead Sponsor

**Class:** OTHER

**Name:** Baylor University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** The lead researcher, data collectors, and participants were blinded to the conditions. The distribution of the supplements for each condition was performed by a member of the staff that was not involved with the study.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 114

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Dietary Supplement: Beetroot Juice

**Label:** Beetroot Juice

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Dietary Supplement: Placebo Control

**Label:** Placebo Control

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Beetroot Juice

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

**Name:** Beetroot Juice

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo Control

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

**Name:** Placebo Control

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

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

**Measure:** 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)

**Description:** Change in IL-8 levels

**Measure:** 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)

#### Secondary Outcomes

**Description:** Resting blood pressure (systolic and diastolic)

**Measure:** 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)

**Description:** Perceived Stress Scale

**Measure:** 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)

**Description:** PANAS negative affect scale

**Measure:** 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)

**Description:** 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

**Measure:** Adherence monitoring (feasibility )

**Time Frame:** Every day, twice a day during active beetroot

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

**Measure:** 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)

**Description:** Hospital Anxiety and Depression Scale

**Measure:** 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)

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Dallas

**Country:** United States

**Facility:** Southern Methodist University

**State:** Texas

**Zip:** 75205

**Location 2:**

**City:** Waco

**Country:** United States

**Facility:** Annie T. Ginty

**State:** Texas

**Zip:** 76798

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: VaDiAg

- Name: Vasodilator Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12507

- Name: Nitric Oxide

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
