The Influence of Beetroot Juice on Racial Disparities in Vascular Health

NCT05132556 | Completed

• 1 other identifier: H22040
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Blood Pressure; Racial Disparities; Cardiovascular Risk Factor

Keywords

blood pressure; arterial stiffness; cardiovascular health; nitric oxide

Outcome Measures

Primary Outcomes (5)

• Changes in nitric oxide (NO) metabolites

  The investigators will use chemiluminescence detection to measure salivary and circulating NO metabolites (nitrate and nitrate).

  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).

  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.

  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.

  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.

  Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)

Secondary Outcomes (6)

• Objective sleep duration

  Baseline (pre-intervention)

• Subjective sleep quality

  Baseline (pre-intervention)

• Physical activity

  Baseline (pre-intervention)

• Habitual dietary intake

  Baseline (pre-intervention)

• Social determinants of health

  Baseline (pre-intervention)

Study Arms (2)

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).

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.

Other: Acute Beetroot Juice

Interventions

Acute Beetroot Juice OTHER

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

Beetroot juice with nitrate removed; Nitrate-rich beetroot juice (~12.8 mmol)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia Southern University: lead

Study Sites (1)

Biodynamics and Human Performance Center

Savannah, Georgia, 31401, United States

Location

Study Officials

• Gregory Grosicki, PhD

  Georgia Southern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The experimenter will be blinded to what condition the participant is in, and all data analysis will be conducted blinded to the condition as well.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 24, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: October 4, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: One year after completion of trial, indefinitely
• 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.

Locations

US (1)