## Protocol Section
### Identification Module
**NCT ID:** NCT05188079

**Brief Title:** Effect of Acute Nitrate Supplementation on Vascular Function in Hispanic, Black and White Population

**Official Title:** Effect of Acute Nitrate Supplementation on Vascular Function in Hispanic, Black and White Population

#### Organization Study ID Info
**ID:** STUDY00001163
#### Organization
**Class:** OTHER
**Full Name:** University of Texas at Austin
### Status Module
#### Completion Date
**Date:** 2026-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-01-12

**Type:** ACTUAL

**Last Update Submit Date:** 2022-01-07

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-10-01

**Type:** ACTUAL

**Status Verified Date:** 2022-01

#### Study First Post Date
**Date:** 2022-01-12
**Type:** ACTUAL
**Study First Submit Date:** 2021-12-08
**Study First Submit QC Date:** 2022-01-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Texas at Austin

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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).

### Conditions Module

**Conditions:**

- Healthy Adults

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** randomized, cross-over, placebo-controlled trial

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** it will be double blinded

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 140 ml of beetroot juice (high nitrate dietary supplement)

**Intervention Names:**

- Dietary Supplement: Beetroot juice

**Label:** Beetroot Juice

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Dietary Supplement: Placebo drink

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Beetroot Juice

**Description:** high nitrate supplement

**Name:** Beetroot juice

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** placebo

**Name:** Placebo drink

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Forearm blood flow

**Time Frame:** through study completion, an average of 2 year

#### Secondary Outcomes

**Description:** 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

**Measure:** Flow mediated vasodilation

**Time Frame:** through study completion, an average of 2 year

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jasdeep.kaur@austin.utexas.edu

**Name:** jasdeep kaur, PhD

**Phone:** 5124718595

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Austin

**Contacts:**

***Contact 1:***

- **Email:** jasdeep.kaur@austin.utexas.edu

- **Name:** Jasdeep Kaur, PhD

- **Phone:** 512-471-8595

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Texas at Austin

**State:** Texas

**Status:** RECRUITING

**Zip:** 78712

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
