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

Sponsor

University of Texas at Austin (Other)

Overall Status

Recruiting

CT.gov ID

NCT05188079

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Dietary Supplement: Beetroot juice Dietary Supplement: Placebo drink	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

randomized, cross-over, placebo-controlled trialrandomized, cross-over, placebo-controlled trial

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

it will be double blinded

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Jan 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Beetroot Juice 140 ml of beetroot juice (high nitrate dietary supplement)	Dietary Supplement: Beetroot juice high nitrate supplement
Placebo Comparator: Placebo Placebo drink looks and tastes like the beetroot juice but has the nitrate removed from the juice.	Dietary Supplement: Placebo drink placebo

Arm

Intervention/Treatment

Active Comparator: Beetroot Juice

140 ml of beetroot juice (high nitrate dietary supplement)

Dietary Supplement: Beetroot juice

high nitrate supplement

Placebo Comparator: Placebo

Placebo drink looks and tastes like the beetroot juice but has the nitrate removed from the juice.

Dietary Supplement: Placebo drink

placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas at Austin	Austin	Texas	United States	78712

Sponsors and Collaborators

University of Texas at Austin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT05188079

Other Study ID Numbers:

STUDY00001163

First Posted:

Jan 12, 2022

Last Update Posted:

Jan 12, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 12, 2022