Effect of Acute Nitrate Supplementation on Vascular Function in Hispanic, Black and White Population

Not Applicable

Recruiting

• Conditions: Healthy Adults
• Interventions: Dietary Supplement: Beetroot juice; Dietary Supplement: Placebo drink

• Registration Number: NCT05188079
• Lead Sponsor: University of Texas at Austin

Brief Summary

The purpose of the study is to assess vascular function in African Americans, Hispanic and Caucasian Americans to better understand racial differences in cardiovascular health. The investigators will further investigate the affect of Beetroot juice on the vascular function of all participants.

Detailed Description

African Americans and Hispanic individuals have the highest incidence of type 2 diabetes, which increases their risk of all cardiovascular diseases. One of the hallmarks of type 2 diabetes is vascular dysfunction, caused by a lack of nitric oxide bioavailability. Vascular function and blood flow responses to exercise have been shown to improve after nitrate supplementation (beetroot juice), However, whether nitrate supplementation will improve vascular function in African American and Hispanic individuals remains unknown. The investigators will perform a randomized, placebo-controlled study in healthy African American, Hispanic and Caucasian subjects. They will be studied before and 90 minutes after consuming Beetroot juice (high nitrate supplement) or Placebo, with at least 1-week washout period between the two visits (Kenjale AA et al., J Appl Physiol 2011).

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-16
• Primary Completion: 2027-08-01
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Healthy men and women who are either Caucasian American, Hispanic, or non-Hispanic African American

Exclusion Criteria

• Blood pressure higher than or equal to 140/90 mmHg
• BMI > 35kg/m2
• Have a history of cardiovascular, neurological or vascular diseases
• Take prescription medications
• Are smokers
• Are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Beetroot Juice	Beetroot juice	140 ml of beetroot juice (high nitrate dietary supplement)
Placebo	Placebo drink	Placebo drink looks and tastes like the beetroot juice but has the nitrate removed from the juice.

Primary Outcome Measures

Name	Time	Method
Forearm blood flow	through study completion, an average of 2 year	Blood flow of the brachial artery will be measured continuously at rest, during 3 min of handgrip exercise and for up to 1 min after the cessation of handgrip exercise.

Secondary Outcome Measures

Name	Time	Method
Flow mediated vasodilation	through study completion, an average of 2 year	The subjects will lay supine with arm extended on a side table. Resting brachial artery diameter and velocity will be measured at rest for 2 min. Following this, a pneumatic cuff will be inflated on the forearm to supersystolic pressure (220-240 Torr) for 5 min and once the cuff is released, brachial artery diameter and velocity will be measured for up to 3 minutes after cuff deflation. FMD% will be calculated as (highest diameter after cuff deflation - baseline brachial artery diameter)/ baseline diameter \* 100

Trial Locations

Locations (1)

University of Texas at Austin; 🇺🇸 Austin, Texas, United States