Clinical trial NCT05132556: The Influence of Beetroot Juice on Racial Disparities in Vascular Health
Official title: The Influence of Beetroot Juice on Racial Disparities in Vascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Racial Disparities
Cardiovascular Risk Factor
Keywords: blood pressure
arterial stiffness
cardiovascular health
nitric oxide
Lead sponsor: Georgia Southern University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in nitric oxide (NO) metabolites
timeFrame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
measure: Changes in blood pressure
timeFrame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
measure: Changes in arterial stiffness
timeFrame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
measure: Changes in blood pressure responses to stress
timeFrame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
measure: Changes in arterial stiffness responses to stress
timeFrame: Baseline and two hours after beetroot juice ingestion, both conditions (experimental and control)
Secondary outcomes:
measure: Objective sleep duration
timeFrame: Baseline (pre-intervention)
measure: Subjective sleep quality
timeFrame: Baseline (pre-intervention)
measure: Physical activity
timeFrame: Baseline (pre-intervention)
measure: Habitual dietary intake
timeFrame: Baseline (pre-intervention)
measure: Social determinants of health
timeFrame: Baseline (pre-intervention)
measure: Economic determinants of health
timeFrame: Baseline (pre-intervention)
Other outcomes:
Locations:
city: Savannah
country: United States
facility: Biodynamics and Human Performance Center
state: Georgia
Study officials:
affiliation: Georgia Southern University
name: Gregory Grosicki, PhD
role: PRINCIPAL_INVESTIGATOR
References: