Beetroot Juice NO Cold Study

NCT06416228 | Recruiting Phase 2 DMC

• 1 other identifier: 23-108
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Currently, there is a lack of evidence-based prevention strategies for respiratory infection and management of these conditions can be costly to the public. Airway nitric oxide provides a first line of defense against pathogens, and beetroot juice, a source of dietary nitrate, has been shown to elevate nitric oxide. The main objective of this project is to demonstrate that one week of supplementation with beetroot juice elevates airway nitric oxide during stressful periods in young adults and thereby can protect against respiratory viral infections.

Conditions

Respiratory Tract Infections; Cold Symptoms; Exhaled Nitric Oxide

Outcome Measures

Primary Outcomes (5)

• 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)

• Viral Polymerase Chain Reaction

  Binary positive/negative test results for a panel of viral and bacterial respiratory pathogens.

  Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period)

• Wisconsin Upper Respiratory Symptom Survey (WURSS)

  Assess 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)

• 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 during active beetroot shots (Days 1-7)

• Burdensomeness

  Follow-up questionnaire will be administered with the online follow-up survey. It explores experience with the best mode of reminder receipt (email or text message), whether the participants guessed their condition, and how burdensome 8 aspects of the study (including daily intake, video recording, upload, questionnaires, physiological assessment) were.

  1-3 days after finishing beetroot shots (after final examinations)

Secondary Outcomes (5)

• Acute stress

  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)

• Cortisol

  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

  Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period)

• Mood

  Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period)

• Blood pressure (systolic and diastolic blood pressure) and heart rate

  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)

Other Outcomes (3)

• One-day Food Record

  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)

• Arginase

  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)

• Asymmetric dimethylarginine

  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)

Study Arms (3)

Two active doses of beetroot juice

EXPERIMENTAL

2 active (nitrate containing) doses of Beet-it Pro 400

Dietary Supplement: Beetroot juice

One active dose of beetroot juice and one placebo dose of beetroot juice

ACTIVE COMPARATOR

1 active (nitrate containing) dose of Beet-it Pro 400 and one placebo (nitrate-depleted) dose of beetroot juice

Dietary Supplement: Beetroot juice

Two placebo doses of beetroot juice

PLACEBO COMPARATOR

2 placebo (nitrate-depleted) doses of beetroot juice

Dietary Supplement: Beetroot juice

Interventions

Beetroot juice DIETARY_SUPPLEMENT

Participants will take on dose in the morning and one in the afternoon, for 7 days during their final academic examinations

Also known as: Beet-it 400

One active dose of beetroot juice and one placebo dose of beetroot juice; Two active doses of beetroot juice; Two placebo doses of beetroot juice

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals will be included:
• SMU or Baylor University students
• Ages of 18-30 years old.

You may not qualify if:

• Active smokers
• Smoking cannabis or vape
• Students with clinically significant asthma
• COPD and emphysema
• Allergic rhinitis
• High levels of exhaled nitric oxide (FENO ≥40ppb)
• Developing kidney stone
• Clinically significant heart disease
• Cerebrovascular disease
• Thyroid dysfunction
• Out-of-control diabetes
• Significant current problems with schizophrenia, psychosis, mood disorders, suicidality, and drug or alcohol dependence or abuse

Sponsors & Collaborators

• Southern Methodist University: lead
• Baylor University: collaborator

Study Sites (2)

Southern Methodist University

Dallas, Texas, 75206, United States

RECRUITING

Baylor University

Waco, Texas, 76796, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Thomas Ritz, Ph.D.

  Southern Methodist University

  PRINCIPAL INVESTIGATOR

• Annie Ginty, Ph.D.

  Baylor University

  STUDY DIRECTOR

Central Study Contacts

Savannah Springfield, BA

CONTACT

(214) 768-6441; sspringfield@mail.smu.edu

Danielle Young, Ph.D.

CONTACT

(254) 710-2236; Danielle_Young@baylor.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participating students and assessors will be blinded to the participants' group assignment. Since students and research staff will not know whether their beetroot juice is depleted or not, treatment conditions are double-blinded (juice "shots" will be pre-labeled by study statistician with a participant number based on the pre-study randomization, so neither the staff nor the participant know the contents). Students will also be assured of full blinding of course instructors, including the PIs and Co-Is, to names of study participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Double blinded, placebo controlled study

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 16, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (2)