- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05132556
The Influence of Beetroot Juice on Racial Disparities in Vascular Health
October 4, 2023 updated by: Gregory Grosicki, Georgia Southern University
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Savannah, Georgia, United States, 31401
- Biodynamics and Human Performance Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Smoking or tobacco use
- Current pregnancy
- Nursing mothers
- Communication barriers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nitrate-rich beetroot juice (~12.8 mmol)
Participants will have blood pressure, arterial stiffness, and blood samples (from venipuncture) assessed before and after the nitrate-rich beetroot juice (~12.8 mmol).
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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
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Placebo Comparator: Beetroot juice with nitrate removed
Participants will have blood pressure, arterial stiffness, and blood samples (from venipuncture) assessed before and after the beetroot juice with nitrate removed.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
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Changes in blood pressure
Time Frame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
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The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA), which will provide brachial and aortic blood pressures (mmHg).
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Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
|
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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.
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Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
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Changes in blood pressure responses to stress
Time Frame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
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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.
|
Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
|
|
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.
|
Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective sleep duration
Time Frame: Baseline (pre-intervention)
|
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.
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Baseline (pre-intervention)
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Subjective sleep quality
Time Frame: Baseline (pre-intervention)
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The investigators will use the Pittsburgh Sleep Quality Index (0-21, higher value indicating worse sleep) to assess subjective indices of sleep health.
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Baseline (pre-intervention)
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Physical activity
Time Frame: Baseline (pre-intervention)
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Participants will wear an ActiGraph GT9X accelerometer for seven days to objectively quantify time spent in moderate-vigorous physical activity.
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Baseline (pre-intervention)
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Habitual dietary intake
Time Frame: Baseline (pre-intervention)
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The investigators will instruct participants to complete a diet log for three days which will be characterized with Nutrition Data System for Research (NSDR).
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Baseline (pre-intervention)
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Social determinants of health
Time Frame: Baseline (pre-intervention)
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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.
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Baseline (pre-intervention)
|
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Economic determinants of health
Time Frame: Baseline (pre-intervention)
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The investigators will use the Socioeconomic Status (0-32, lower score indicating lower socioeconomic status) questionnaire to quantify economic determinants of health.
|
Baseline (pre-intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gregory Grosicki, PhD, Georgia Southern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Actual)
May 1, 2023
Study Completion (Actual)
October 4, 2023
Study Registration Dates
First Submitted
November 5, 2021
First Submitted That Met QC Criteria
November 12, 2021
First Posted (Actual)
November 24, 2021
Study Record Updates
Last Update Posted (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
October 4, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- H22040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals
IPD Sharing Time Frame
One year after completion of trial, indefinitely
IPD Sharing Access Criteria
A formal plan identifying the intended use of the data and proper completion of a DMDA and MTA (if needed) with Georgia Southern University and the study PI.
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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