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Recruiting NCT05188079

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

No phase Interventional Healthy Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Beetroot juice, Placebo drink.
Who it may be relevant to
Registry conditions: Healthy Adults. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

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

Primary outcome measures

  • Forearm blood flow [Time frame: through study completion, an average of 2 year]
Secondary outcome measures (1)
  • Flow mediated vasodilation [Time frame: through study completion, an average of 2 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Texas at Austin — Austin

Identifiers

NCT: NCT05188079 · STUDY00001163

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗