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

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188079
• Other study ID #: STUDY00001163
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: January 2022
• Source: University of Texas at Austin
• Contact: jasdeep kaur, PhD
• Phone: 5124718595
• Email: jasdeep.kaur[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 31, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• Beetroot juice
high nitrate supplement
• Placebo drink
placebo

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm blood flow	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.	through study completion, an average of 2 year
Secondary	Flow mediated vasodilation	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	through study completion, an average of 2 year