Respiratory Tract InfectionsPhase 2NCSNCT06416228
Beetroot Juice NO Cold Study
A Phase 2 study testing Beetroot juice in people with Respiratory Tract Infections and Cold Symptoms, run by Southern Methodist University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Cold Symptoms, Exhaled Nitric Oxide
- What is being tested?
- Beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Apr 2024to 15 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals will be included:
- SMU or Baylor University students
- Ages of 18-30 years old.
Who cannot join
- Active smokers
- Smoking cannabis or vape
- Students with clinically significant asthma
- COPD and emphysema
- Allergic rhinitis
- High levels of exhaled nitric oxide (FENO ≥40ppb)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Southern Methodist University
Dallas, Texas, 75206
Savannah Springfield, BA, 214-768-6441, sspringfield@smu.edu
- Recruiting
Baylor University
Waco, Texas, 76796
Danielle Young, Ph.D., 254-710-2236, Danielle_Young@baylor.edu
About this study
Official title: Beetroot Juice Supplement for Boosting Mucosal Immunity - The NO Cold Study
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.
Read the detailed description
Study Title Beetroot Juice Supplement for Boosting Mucosal Immunity: The NO Cold Study
Objectives Aim 1: Demonstrate that a 7-day trial of daily beetroot juice or nitrate depleted placebo beetroot juice is feasible with acceptable retention and adherence during a period of real-life stress, using adherence monitoring of beetroot juice intake by cell phone recorded video; acceptable burdensomeness for participants and success of team coordination and study logistics should also be demonstrated.
Aim 2: Generate initial estimates of effect size for a) elevations in exhaled nitric oxide (FENO) and b) the correlation between changes in FENO and both infection reduction and cold symptom reduction (biological signature).
Aim 3: a) Examine if 2 daily doses of beetroot juice are more potent than 1 daily dose in elevating FENO, and b) investigate whether each beetroot juice dosage (1 dose and 2 doses) increases FENO more than the placebo.
Exploratory aims: Explore sex as a moderator of all the Aims. Also explore effects of competitors/inhibitors of NO (arginase, asymmetric dimethylarginine) in a) reducing FENO under stress, and b) whether beetroot juice buffers any of these potential adverse effects on FENO; c) investigate whether effects of stress cortisol, which negatively impact NO, cold symptoms, and respiratory infections, are also buffered by beetroot juice.
Design and Outcomes This is a double-blind, placebo controlled clinical trial to test the efficacy of beetroot juice as elevating airway NO, which is associated with reduced cold symptoms and respiratory viral infection rates, in undergraduate students aged 18-30.
Interventions and Duration Participants will be receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice, 2 active daily doses of beetroot juice, or 2 daily doses of nitrate-depleted placebo beetroot.
Cold symptoms will be explored by questionnaire at baseline (in a low stress period during the semester) and subsequently twice during the final exam period, once at an early stage of the finals (days 1-3 of the final exam period), and once at a later stage (days 4-6). A follow-up online questionnaire packet will be administered 3 days after the last final day. FENO, sampling for viral PCR, salivary cortisol, and exhaled breath condensate will be undertaken at baseline, early finals, and late finals (in-person assessments are not feasible at follow-up, because students leave campus after finals).
Sample Size and Population The sample size is 150 students (n=66 at SMU site, n=84 at Baylor site). Female and male students 18-30 years old will be recruited from Baylor and SMU. The investigators will make an extra effort to guarantee equal representation of both genders. Participants can be from any ethnic or cultural background, as long as they can understand and read English adequately. The student population of both universities combined is diverse (28.5-38.5% minorities).
The investigators will stratify by sex and by site, to randomize participants to receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice, 2 active daily doses of beetroot juice, or 2 daily doses of nitrate-depleted placebo beetroot juice (n=50 per group).
- Being tested
- Beetroot juice
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
Also called Beet-it 400
Participants will take on dose in the morning and one in the afternoon, for 7 days during their final academic examinations
| Study group | Role | What they receive |
|---|---|---|
| Two active doses of beetroot juice | Experimental | 2 active (nitrate containing) doses of Beet-it Pro 400 Receives: 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 Receives: Dietary Supplement: Beetroot juice |
| Two placebo doses of beetroot juice | Placebo comparator | 2 placebo (nitrate-depleted) doses of beetroot juice Receives: Dietary Supplement: Beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Nitric Oxide
The Fraction of NO in Exhaled Breath (FENO, in ppb) will be measured with an electrochemical gas analyzer (NIOX vero).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 1-3 days after finishing beetroot shots (after final examinations)
Secondary outcomes (5)
Acute stress
Ad-hoc acute stress rating
Measured: 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
Cortisol, from saliva sampled with passive drool test
Measured: 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
Perceived Stress Scale (PSS)
Measured: Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period)
Mood
Hospital Anxiety and Depression Scale (HADS)
Measured: 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
Measured after at least 10 min of acclimatization to the laboratory
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start2 Apr 2024
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, placebo controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor University
- Responsible party
- Principal investigator, Thomas Ritz, Southern Methodist University
- Investigators
- Thomas Ritz, Ph.D., Principal investigator, Southern Methodist UniversityAnnie Ginty, Ph.D., Study director, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416228
- Sponsor's protocol ID
- 23-108
- Acronym
- NCS
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beetroot Juice Supplement for Boosting Mucosal Immunity - The NO Cold Study
- ClinicalTrials.gov ID
- NCT06416228
- Acronym / sponsor ID
- NCS / 23-108
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Collaborators
- Baylor University
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Title Beetroot Juice Supplement for Boosting Mucosal Immunity: The NO Cold Study
Objectives Aim 1: Demonstrate that a 7-day trial of daily beetroot juice or nitrate depleted placebo beetroot juice is feasible with acceptable retention and adherence during a period of real-life stress, using adherence monitoring of beetroot juice intake by cell phone recorded video; acceptable burdensomeness for participants and success of team coordination and study logistics should also be demonstrated.
Aim 2: Generate initial estimates of effect size for a) elevations in exhaled nitric oxide (FENO) and b) the correlation between changes in FENO and both infection reduction and cold symptom reduction (biological signature).
Aim 3: a) Examine if 2 daily doses of beetroot juice are more potent than 1 daily dose in elevating FENO, and b) investigate whether each beetroot juice dosage (1 dose and 2 doses) increases FENO more than the placebo.
Exploratory aims: Explore sex as a moderator of all the Aims. Also explore effects of competitors/inhibitors of NO (arginase, asymmetric dimethylarginine) in a) reducing FENO under stress, and b) whether beetroot juice buffers any of these potential adverse effects on FENO; c) investigate whether effects of stress cortisol, which negatively impact NO, cold symptoms, and respiratory infections, are also buffered by beetroot juice.
Design and Outcomes This is a double-blind, placebo controlled clinical trial to test the efficacy of beetroot juice as elevating airway NO, which is associated with reduced cold symptoms and respiratory viral infection rates, in undergraduate students aged 18-30.
Interventions and Duration Participants will be receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice, 2 active daily doses of beetroot juice, or 2 daily doses of nitrate-depleted placebo beetroot.
Cold symptoms will be explored by questionnaire at baseline (in a low stress period during the semester) and subsequently twice during the final exam period, once at an early stage of the finals (days 1-3 of the final exam period), and once at a later stage (days 4-6). A follow-up online questionnaire packet will be administered 3 days after the last final day. FENO, sampling for viral PCR, salivary cortisol, and exhaled breath condensate will be undertaken at baseline, early finals, and late finals (in-person assessments are not feasible at follow-up, because students leave campus after finals).
Sample Size and Population The sample size is 150 students (n=66 at SMU site, n=84 at Baylor site). Female and male students 18-30 years old will be recruited from Baylor and SMU. The investigators will make an extra effort to guarantee equal representation of both genders. Participants can be from any ethnic or cultural background, as long as they can understand and read English adequately. The student population of both universities combined is diverse (28.5-38.5% minorities).
The investigators will stratify by sex and by site, to randomize participants to receiving 1 active daily dose of beetroot juice and 1 dose of nitrate-depleted placebo beetroot juice, 2 active daily doses of beetroot juice, or 2 daily doses of nitrate-depleted placebo beetroot juice (n=50 per group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double blinded, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Two active doses of beetroot juice | Experimental | Dietary Supplement: Beetroot juice2 active (nitrate containing) doses of Beet-it Pro 400 |
| One active dose of beetroot juice and one placebo dose of beetroot juice | Active comparator | Dietary Supplement: Beetroot juice1 active (nitrate containing) dose of Beet-it Pro 400 and one placebo (nitrate-depleted) dose of beetroot juice |
| Two placebo doses of beetroot juice | Placebo comparator | Dietary Supplement: Beetroot juice2 placebo (nitrate-depleted) doses of beetroot juice |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- SMU or Baylor University students
- Ages of 18-30 years old.
Key exclusion criteria (12 listed)
- Active smokers
- Smoking cannabis or vape
- Students with clinically significant asthma
- COPD and emphysema
- Allergic rhinitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juiceAlso: Beet-it 400Participants will take on dose in the morning and one in the afternoon, for 7 days during their final academic examinations | Dietary supplement | 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 |
Primary outcome
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).
Viral Polymerase Chain Reaction
Time frame: Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period)
Binary positive/negative test results for a panel of viral and bacterial respiratory pathogens.
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)
Assess symptoms of acute upper respiratory tract infections (common cold symptoms) by questionnaire
Adherence monitoring (feasibility)
Time frame: Every day during active beetroot shots (Days 1-7)
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
Burdensomeness
Time frame: 1-3 days after finishing beetroot shots (after final examinations)
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.
5 secondary outcomes
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), 1-3 days after finishing beetroot shots (after final examinations)
Cortisol
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
Time frame: Baseline (non-stress mid point of semester), 4-6 days into active beetroot shots (during final examination period)
Mood
Time frame: 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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ritz, Ph.D. principal investigator
Southern Methodist University
Annie Ginty, Ph.D. study director
Baylor University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beetroot juice in people with Respiratory Tract Infections and Cold Symptoms, run by Southern Methodist University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Savannah Springfield, BA ((214) 768-6441, sspringfield@mail.smu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.