Blood PressureNCT05132556
The Influence of Beetroot Juice on Racial Disparities in Vascular Health
A study testing Acute Beetroot Juice in people with Blood Pressure and Racial Disparities, run by Georgia Southern University at 1 site in United States.
Trial summary
Black adults are 30% more likely to die from cardiovascular disease (CVD) compared to White adults, and more than half of this racial disparity in cardiovascular mortality may be attributed to the substantially greater prevalence of high blood pressure and vascular dysfunction in Black adults. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Racial Disparities, Cardiovascular Risk Factor
- What is being tested?
- Acute Beetroot Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 4 Oct 2023
- 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 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-39 years of age
- Body mass index (BMI) below 30 kg/m^2
- Free from signs or symptoms of neurologic, cardiovascular (e.g., heart attack, stroke, heart failure, arrhythmia), metabolic, and/or renal disease
- Have a blood pressure no lower than 90/50 mmHg
- Are not currently smoking, using smokeless tobacco, nor smoked within the past 12 months
Who cannot join
- Low blood pressure - less than 90/50 mmHg
- History of cardiovascular disease
- History of cancer
- History of diabetes
- History of kidney disease
- Obesity (BMI > 30 kg/m^2)
Show all 10Show fewer
- Smoking or tobacco use
- Current pregnancy
- Nursing mothers
- Communication barriers
Trial locations and contacts
1 site in 1 country.
United States1 site
Biodynamics and Human Performance Center
Savannah, Georgia, 31401
About this study
Black adults are 30% more likely to die from cardiovascular disease (CVD) compared to White adults, and more than half of this racial disparity in cardiovascular mortality may be attributed to the substantially greater prevalence of high blood pressure and vascular dysfunction in Black adults. Nitric oxide (NO) is a potent signaling molecule and key regular of vascular function that is suspected to be reduced in black individuals, but can be enriched by dietary nitrate (e.g., arugula, spinach, beets). The purpose of this study is to test the hypothesis that increasing NO bioavailability via nitrate-rich beetroot juice (BRJ) will lower blood pressure and improve vascular health in Black adults.
Read the detailed description
The investigators long-term research goal is to investigate mechanisms accounting for the higher prevalence of CVD and high blood pressure in Black individuals, and identify effective preventive strategies. Nitric oxide (NO) is a gaseous molecule that plays an essential role in the regulation of vascular tone and blood pressure regulation. Some, but not all, studies have observed reduced NO bioavailability in Black individuals, which may contribute to racial disparities in vascular health. Dietary nitrate supplementation using beetroot juice (BRJ) is demonstrated to increase circulating NO, lower blood pressure and arterial stiffness, and improve blood pressure regulation in clinical populations and health individuals. The central hypothesis is that increasing NO bioavailability by nitrate-rich BRJ supplementation will lower blood pressure and improve vascular health in Black adults. The investigators acknowledge that racial differences are not entirely driven by ancestry, and thus will assess and account for sociocultural factors and health behaviors (i.e., sleep, physical activity, and nutrition) that may contribute to racial health disparities.
- Being tested
- Acute Beetroot Juice
- Keywords
- blood pressure, arterial stiffness, cardiovascular health, nitric oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Beetroot JuiceOther
Participants will ingest a beetroot juice supplement with and without inorganic nitrate to determine the effects of acute dietary nitrate ingestion on blood pressure and arterial stiffness
| Study group | Role | What they receive |
|---|---|---|
| Nitrate-rich beetroot juice (~12.8 mmol) | Experimental | Participants will have blood pressure, arterial stiffness, and blood samples (from venipuncture) assessed before and after the nitrate-rich beetroot juice (~12.8 mmol). Receives: Other: Acute Beetroot Juice |
| Beetroot juice with nitrate removed | Placebo comparator | Participants will have blood pressure, arterial stiffness, and blood samples (from venipuncture) assessed before and after the beetroot juice with nitrate removed. Receives: Other: Acute Beetroot Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in nitric oxide (NO) metabolites
The investigators will use chemiluminescence detection to measure salivary and circulating NO metabolites (nitrate and nitrate).
Measured: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
Changes in blood pressure
The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA), which will provide brachial and aortic blood pressures (mmHg).
Measured: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
Changes in arterial stiffness
The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV). A high-fidelity strain-gauge transducer is used to obtain the pressure waveform at the carotid pulse. Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded. PWV will be expressed as m/s.
Measured: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
Changes in blood pressure responses to stress
The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) at rest and during handgrip exercise and after exercise during cuff occlusion.
Measured: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
Changes in arterial stiffness responses to stress
The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV) at rest and during handgrip exercise and after exercise during cuff occlusion.
Measured: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
Secondary outcomes (6)
Objective sleep duration
ActiGraph GT9X accelerometers will be used to quantify sleep duration. Participants will wear the watch unit for 7 days. The investigators will assess qualitative sleep scores and cross-check actigraphy wear times with a sleep diary.
Measured: Baseline (pre-intervention)
Subjective sleep quality
The investigators will use the Pittsburgh Sleep Quality Index (0-21, higher value indicating worse sleep) to assess subjective indices of sleep health.
Measured: Baseline (pre-intervention)
Physical activity
Participants will wear an ActiGraph GT9X accelerometer for seven days to objectively quantify time spent in moderate-vigorous physical activity.
Measured: Baseline (pre-intervention)
Habitual dietary intake
The investigators will instruct participants to complete a diet log for three days which will be characterized with Nutrition Data System for Research (NSDR).
Measured: Baseline (pre-intervention)
Social determinants of health
The investigators will use the Perceived Ethic Discrimination Questionnaire (22-154, higher value indicating more experiences of ethnic discrimination/racism) to quantify social determinants of health.
Measured: Baseline (pre-intervention)
Economic determinants of health
The investigators will use the Socioeconomic Status (0-32, lower score indicating lower socioeconomic status) questionnaire to quantify economic determinants of health.
Measured: Baseline (pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Nov 2021
- Primary completion1 May 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention is to provide participants with either nitrate-rich (\~12.8 mmol nitrate; 140 mL) beetroot juice or an indistinguishable equal volume placebo with nitrate removed, the order of which will be randomized.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Southern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Grosicki, Georgia Southern University
- Investigators
- Gregory Grosicki, PhD, Principal investigator, Georgia Southern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132556
- Sponsor's protocol ID
- H22040
- Status last verified
- Oct 2023
- First submitted
- 5 Nov 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Beetroot Juice on Racial Disparities in Vascular Health
- ClinicalTrials.gov ID
- NCT05132556
- Acronym / sponsor ID
- H22040
- Keywords
- blood pressure, arterial stiffness, cardiovascular health, nitric oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Georgia Southern UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 24 Nov 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.
Black adults are 30% more likely to die from cardiovascular disease (CVD) compared to White adults, and more than half of this racial disparity in cardiovascular mortality may be attributed to the substantially greater prevalence of high blood pressure and vascular dysfunction in Black adults. Nitric oxide (NO) is a potent signaling molecule and key regular of vascular function that is suspected to be reduced in black individuals, but can be enriched by dietary nitrate (e.g., arugula, spinach, beets). The purpose of this study is to test the hypothesis that increasing NO bioavailability via nitrate-rich beetroot juice (BRJ) will lower blood pressure and improve vascular health in Black adults.
Detailed description
The investigators long-term research goal is to investigate mechanisms accounting for the higher prevalence of CVD and high blood pressure in Black individuals, and identify effective preventive strategies. Nitric oxide (NO) is a gaseous molecule that plays an essential role in the regulation of vascular tone and blood pressure regulation. Some, but not all, studies have observed reduced NO bioavailability in Black individuals, which may contribute to racial disparities in vascular health. Dietary nitrate supplementation using beetroot juice (BRJ) is demonstrated to increase circulating NO, lower blood pressure and arterial stiffness, and improve blood pressure regulation in clinical populations and health individuals. The central hypothesis is that increasing NO bioavailability by nitrate-rich BRJ supplementation will lower blood pressure and improve vascular health in Black adults. The investigators acknowledge that racial differences are not entirely driven by ancestry, and thus will assess and account for sociocultural factors and health behaviors (i.e., sleep, physical activity, and nutrition) that may contribute to racial health disparities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The intervention is to provide participants with either nitrate-rich (~12.8 mmol nitrate; 140 mL) beetroot juice or an indistinguishable equal volume placebo with nitrate removed, the order of which will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Nitrate-rich beetroot juice (~12.8 mmol) | Experimental | Other: Acute Beetroot JuiceParticipants will have blood pressure, arterial stiffness, and blood samples (from venipuncture) assessed before and after the nitrate-rich beetroot juice (~12.8 mmol). |
| Beetroot juice with nitrate removed | Placebo comparator | Other: Acute Beetroot JuiceParticipants will have blood pressure, arterial stiffness, and blood samples (from venipuncture) assessed before and after the beetroot juice with nitrate removed. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 18-39 years of age
- Body mass index (BMI) below 30 kg/m^2
- Free from signs or symptoms of neurologic, cardiovascular (e.g., heart attack, stroke, heart failure, arrhythmia), metabolic, and/or renal disease
- Have a blood pressure no lower than 90/50 mmHg
- Are not currently smoking, using smokeless tobacco, nor smoked within the past 12 months
Key exclusion criteria (10 listed)
- Low blood pressure - less than 90/50 mmHg
- History of cardiovascular disease
- History of cancer
- History of diabetes
- History of kidney disease
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 |
|---|---|---|
| Acute Beetroot JuiceParticipants will ingest a beetroot juice supplement with and without inorganic nitrate to determine the effects of acute dietary nitrate ingestion on blood pressure and arterial stiffness | Other | Beetroot juice with nitrate removed, Nitrate-rich beetroot juice (~12.8 mmol) |
Primary outcome
Changes in nitric oxide (NO) metabolites
Time frame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
The investigators will use chemiluminescence detection to measure salivary and circulating NO metabolites (nitrate and nitrate).
Changes in blood pressure
Time frame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA), which will provide brachial and aortic blood pressures (mmHg).
Changes in arterial stiffness
Time frame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV). A high-fidelity strain-gauge transducer is used to obtain the pressure waveform at the carotid pulse. Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded. PWV will be expressed as m/s.
Changes in blood pressure responses to stress
Time frame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) at rest and during handgrip exercise and after exercise during cuff occlusion.
Changes in arterial stiffness responses to stress
Time frame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV) at rest and during handgrip exercise and after exercise during cuff occlusion.
6 secondary outcomes
Objective sleep duration
Time frame: Baseline (pre-intervention)
Subjective sleep quality
Time frame: Baseline (pre-intervention)
Physical activity
Time frame: Baseline (pre-intervention)
Habitual dietary intake
Time frame: Baseline (pre-intervention)
Social determinants of health
Time frame: Baseline (pre-intervention)
Economic determinants of health
Time frame: Baseline (pre-intervention)
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 5 Oct 2023.
- Individual participant dataSharing planned: Yes. Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals
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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.
Gregory Grosicki, PhD principal investigator
Georgia Southern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Beetroot Juice in people with Blood Pressure and Racial Disparities, run by Georgia Southern University 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 10 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 5 Oct 2023. 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?
Changes in nitric oxide (NO) metabolites (time frame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)). 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 5 Oct 2023.