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MitoQ for High Blood Pressure (MAVHS Trial)

N/A

Recruiting

Research Sponsored by Auburn University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a BMI below 35 Kg/m2 (otherwise healthy)

Are between the ages of 19-75

Must not have

History of cardiovascular disease

History of kidney disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-intervention)

Summary

This trial will help explain why black individuals are at increased cardiovascular disease risk and if mitochondrial reactive oxygen species play a role in this.

Who is the study for?

This trial is for black and white individuals aged 19-75 with blood pressure no higher than 150/90 mmHg, a BMI below 35, not currently smoking or having smoked in the past year. They should be free from diabetes, kidney disease, pulmonary disorders, cardiovascular diseases, and must not be on blood thinners or have any issues that prevent exercise.

What is being tested?

The study tests if MitoQ affects blood vessel function and nervous system regulation of blood pressure differently across races. It aims to understand racial disparities in hypertension and cardiovascular risk by observing changes in those with elevated blood pressure or stage 1 hypertension.

What are the potential side effects?

Potential side effects are not explicitly listed but may include allergic reactions to MitoQ. Participants will be monitored for any adverse effects related to mitochondrial reactive oxygen species' influence on neurovascular function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is under 35.

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I am between 19 and 75 years old.

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I have not smoked or used tobacco in the last year.

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I do not have diabetes, kidney disease, lung problems, or heart and blood vessel diseases.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart disease.

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I have a history of kidney disease.

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I have a history of diabetes.

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I have had cancer in the past.

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My BMI is over 30.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and one hour after supplementation or placebo

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and one hour after supplementation or placebo

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and one hour after supplementation or placebo for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in blood biomarkers of nitric oxide bioavailability

Changes in blood pressure reactivity

Changes in circulating reactive oxygen species

+3 more

Secondary study objectives

Cardiorespiratory fitness

Habitual dietary intake

Mental health - depression

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MitoQExperimental Treatment1 Intervention

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).

Group II: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MitoQ

2006

Completed Phase 2

~250

0 / 9Eligibility criteria met