NCT05188079

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Oct 2021Jan 2028

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

5.8 years

First QC Date

December 8, 2021

Last Update Submit

January 13, 2025

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Flow mediated vasodilation

    through study completion, an average of 2 year

Study Arms (2)

Beetroot Juice

ACTIVE COMPARATOR

140 ml of beetroot juice (high nitrate dietary supplement)

Dietary Supplement: Beetroot juice

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo drink

Interventions

Beetroot juiceDIETARY_SUPPLEMENT

high nitrate supplement

Beetroot Juice
Placebo drinkDIETARY_SUPPLEMENT

placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

Central Study Contacts

jasdeep kaur, PhD

CONTACT

5124718595jasdeep.kaur@austin.utexas.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
it will be double blinded
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: randomized, cross-over, placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

January 12, 2022

Study Start

October 1, 2021

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

January 16, 2025

Record last verified: 2025-01

Locations

US(1)