Recruiting

Observational Study

Sponsor:

Auburn University

Code:

NCT04334135

Conditions

Racial Disparities

Blood Pressure

Cardiovascular Risk Factor

Renal Function

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Interventions

MitoQ

Study Details

Brief summary:

Black individuals are at increased cardiovascular disease risk. The central goal of the study is to determine if mitochondrial reactive oxygen species influence blood vessel function and nervous system regulation of blood pressure differentially in black, compared to white individuals. These findings may help to explain a potential mechanism that contributes to racial disparities in blood pressure and cardiovascular disease risk. A secondary goal is to determine if mitochondrial reactive oxygen species improves blood pressure and vascular function in individuals with elevated blood pressure and stage 1 hypertension.

Conditions

Racial Disparities

Blood Pressure

Cardiovascular Risk Factor

Renal Function

Study ID

NCT04334135

Start date

Oct 2, 2020

Status verified date

May, 2024

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Are between the ages of 19-75.
  • Have blood pressure no higher than 150/90 mmHg.
  • Have a BMI below 35 Kg/m2 (otherwise healthy)
  • Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD \& cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
  • Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners).
  • Are not currently smoking, using smokeless tobacco, nor smoked within the past 12 months.

Exclusion Criteria:

  • Known allergy to MitoQ
  • High blood pressure - greater the 150/90 mmHg
  • Low blood pressure - less than 90/50 mmHg
  • History of cardiovascular disease
  • History of cancer
  • History of diabetes
  • History of kidney disease
  • Obesity (BMI > 30 kg/m2)
  • Smoking or tobacco use
  • Current pregnancy
  • Nursing mothers
  • Communication barriers

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: MitoQ

Participants will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed before and after acute MitoQ supplementation (80 - 160mg).

placebo comparator: Placebo

Participants will have sympathetic nerve activity, vascular function, blood pressure and blood samples (from intravenous catheters) assessed before and after a placebo matched in appearance to the MitoQ.

Interventions

MitoQ

Four to eight 20mg capsules (depending on body mass)

Primary outcome measure

  • Changes in flow-mediated dilation (FMD) [ Time Frame: Before and one hour after supplementation or placebo ]
  • Changes in indices of arterial stiffness [ Time Frame: Before and one hour after supplementation or placebo ]
  • Changes in muscle sympathetic nerve activity (MSNA) and sympathetic transduction [ Time Frame: Before and one hour after supplementation or placebo ]
  • Changes in blood pressure reactivity [ Time Frame: Before and one hour after supplementation or placebo ]
  • Changes in circulating reactive oxygen species [ Time Frame: Before and one hour after supplementation or placebo ]
  • Changes in blood biomarkers of nitric oxide bioavailability [ Time Frame: Before and one hour after supplementation or placebo ]

Central Contacts and Locations

Central contacts

Austin T Robinson, PhD

334 844 1619atr0026@auburn.edu

Zachary J Hutchison, MS

zzh0026@auburn.edu

Locations

Kinesiology Building

Recruiting

Auburn, Alabama, United States, 36849

Contacts

Mary Rudisill, PhD

334-844-1458rudisme@auburn.edu

Jared Russell, PhD

(334) 844-1429russej3@auburn.edu

Principal Investigator:

Austin Robinson, PhD

More Information

Sponsor

Auburn University

Last update posted

May 29, 2024

Last verified

May, 2024

Keywords

  • blood pressure
  • hypertension
  • cardiovascular health
  • renal function
  • health disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Auburn University on 2024-05-29.