Coronary Artery DiseaseNCT04920799
Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function
A study testing Nitrate rich beetroot juice and Nitrate depleted beetroot juice in people with Coronary Artery Disease, run by University of Florida at 1 site in United States.
Trial summary
Older adults with coronary artery disease (CAD) have impaired vascular and inspiratory muscle function. The overarching goal of this double-blind, randomized, crossover, placebo-controlled pilot trial was to inform the development of a fully powered trial to evaluate the effects of dietary nitrate supplementation in… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Nitrate rich beetroot juice and Nitrate depleted beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2021to 28 Aug 2025
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with coronary artery disease (CAD) based on an angiogram >50% stenosis in any major epicardial vessel or history of myocardial infarction or history of coronary revascularization.
- Considered to have stable CAD on optimal medical therapy
- 60 to 85 years of age
- Males and females (females must be postmenopausal either natural or surgical)
- Able to give consent
Who cannot join
- Unstable angina, recent myocardial infarction or heart failure within 6 months
- Coronary revascularization, including percutaneous coronary intervention and coronary artery bypass graft or thoracic surgery within 6 months.
- Stroke, obstructive pulmonary disease, hepatitis B, C, HIV, seizures, or other relevant ongoing or recurrent illness
- Individuals who have participated in respiratory training within the last 12 months or cardiac rehabilitation within the last 6 months
- Uncontrolled hypertension
- Use of tobacco products including smoking traditional or e-cigarettes
Show all 9Show fewer
- Use of hormone replacement therapy in women or men (e.g., estrogen, progesterone or testosterone)
- Unwilling to stop using mouthwash at least 1 week before the start of the study and during study participation
- Unwilling to remain weight stable during study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Cardiovascular Physiology Laboratory, University of Florida
Gainesville, Florida, 32611
About this study
Older adults with coronary artery disease (CAD) have impaired vascular and inspiratory muscle function. The overarching goal of this double-blind, randomized, crossover, placebo-controlled pilot trial was to inform the development of a fully powered trial to evaluate the effects of dietary nitrate supplementation in older adults with CAD. We aimed to address the following objectives: (a) assess the feasibility, tolerability, and safety of the study protocol; (b) gather preliminary evidence on the effects of nitrate-rich beetroot juice compared with nitrate-depleted beetroot juice (placebo), and estimate the effect sizes; and (c) determine if a full-scale definitive trial is justified.
- Conditions
- Coronary Artery Disease
- Being tested
- Nitrate rich beetroot juice, Nitrate depleted beetroot juice
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrate rich beetroot juiceDietary supplement
Participants will drink nitrate rich beetroot juice (2.4 floz ; Beet It Sport Nitrate 400 concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks.
Nitrate depleted beetroot juiceDietary supplement
Participants will drink nitrate depleted beetroot juice (2.4 floz ; Beet It placebo concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nitrate rich beetroot juice | Active comparator | Not described Receives: Dietary Supplement: Nitrate rich beetroot juice |
| Nitrate depleted beetroot juice | Placebo comparator | Not described Receives: Dietary Supplement: Nitrate depleted beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function
Endothelial function will be determined using brachial artery flow-mediated dilation via high resolution duplex ultrasonography. Reactive hyperemia will be produced by inflating a forearm cuff to ~250 mmHg for 5 minutes followed by rapid deflation.
Measured: Baseline up to following 2 weeks of experimental condition
Change in inspiratory muscle function
Inspiratory muscle function including strength, power and endurance will be assessed using the POWERbreathe KH2 device
Measured: Baseline up to following 2 weeks of experimental condition
Secondary outcomes (4)
Change in microvascular function
Microvascular function will be assessed using the forearm blood flow response to submaximal handgrip exercise. Brachial artery blood flow and diameter will be assessed using ultrasound.
Measured: Baseline up to following 2 weeks of experimental condition
Change in central arterial stiffness
The SphygmoCor XCEL device will be used to measure carotid to femoral pulse wave velocity.
Measured: Baseline up to following 2 weeks of experimental condition
Change in central arterial hemodynamics
The SphygmoCor XCEL device will be used to obtain central pulse wave analysis.
Measured: Baseline up to following 2 weeks of experimental condition
Change in functional capacity
Using the Duke Activity Status Index we will assess participants' ability to perform daily activities.
Measured: Baseline up to following 2 weeks of experimental condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start12 Nov 2021
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920799
- Sponsor's protocol ID
- IRB202100040
- Status last verified
- May 2026
- First submitted
- 27 May 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function
- ClinicalTrials.gov ID
- NCT04920799
- Acronym / sponsor ID
- IRB202100040
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 10 Jun 2021 (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.
Older adults with coronary artery disease (CAD) have impaired vascular and inspiratory muscle function. The overarching goal of this double-blind, randomized, crossover, placebo-controlled pilot trial was to inform the development of a fully powered trial to evaluate the effects of dietary nitrate supplementation in older adults with CAD. We aimed to address the following objectives: (a) assess the feasibility, tolerability, and safety of the study protocol; (b) gather preliminary evidence on the effects of nitrate-rich beetroot juice compared with nitrate-depleted beetroot juice (placebo), and estimate the effect sizes; and (c) determine if a full-scale definitive trial is justified.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate rich beetroot juice | Active comparator | Dietary Supplement: Nitrate rich beetroot juice |
| Nitrate depleted beetroot juice | Placebo comparator | Dietary Supplement: Nitrate depleted beetroot juice |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults with coronary artery disease (CAD) based on an angiogram >50% stenosis in any major epicardial vessel or history of myocardial infarction or history of coronary revascularization.
- Considered to have stable CAD on optimal medical therapy
- 60 to 85 years of age
- Males and females (females must be postmenopausal either natural or surgical)
- Able to give consent
Key exclusion criteria (9 listed)
- Unstable angina, recent myocardial infarction or heart failure within 6 months
- Coronary revascularization, including percutaneous coronary intervention and coronary artery bypass graft or thoracic surgery within 6 months.
- Stroke, obstructive pulmonary disease, hepatitis B, C, HIV, seizures, or other relevant ongoing or recurrent illness
- Individuals who have participated in respiratory training within the last 12 months or cardiac rehabilitation within the last 6 months
- Uncontrolled hypertension
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 |
|---|---|---|
| Nitrate rich beetroot juiceParticipants will drink nitrate rich beetroot juice (2.4 floz ; Beet It Sport Nitrate 400 concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks. | Dietary supplement | Nitrate rich beetroot juice |
| Nitrate depleted beetroot juiceParticipants will drink nitrate depleted beetroot juice (2.4 floz ; Beet It placebo concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks. | Dietary supplement | Nitrate depleted beetroot juice |
Primary outcome
Change in endothelial function
Time frame: Baseline up to following 2 weeks of experimental condition
Endothelial function will be determined using brachial artery flow-mediated dilation via high resolution duplex ultrasonography. Reactive hyperemia will be produced by inflating a forearm cuff to ~250 mmHg for 5 minutes followed by rapid deflation.
Change in inspiratory muscle function
Time frame: Baseline up to following 2 weeks of experimental condition
Inspiratory muscle function including strength, power and endurance will be assessed using the POWERbreathe KH2 device
4 secondary outcomes
Change in microvascular function
Time frame: Baseline up to following 2 weeks of experimental condition
Change in central arterial stiffness
Time frame: Baseline up to following 2 weeks of experimental condition
Change in central arterial hemodynamics
Time frame: Baseline up to following 2 weeks of experimental condition
Change in functional capacity
Time frame: Baseline up to following 2 weeks of experimental condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrate rich beetroot juice and Nitrate depleted beetroot juice in people with Coronary Artery Disease, run by University of Florida at 1 site 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelial function (time frame: Baseline up to following 2 weeks of experimental condition). The study lists 2 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 14 May 2026.