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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-intervention)

Awards & highlights

MAVHS Trial 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.Check my eligibility

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.See study design

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.

MAVHS Trial 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.

MAVHS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in blood biomarkers of nitric oxide bioavailability

Changes in blood pressure reactivity

Changes in circulating reactive oxygen species

+3 more

Secondary outcome measures

Cardiorespiratory fitness

Habitual dietary intake

Mental health - depression

+4 more

MAVHS 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

~230

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Auburn UniversityLead Sponsor

72 Previous Clinical Trials

14,345 Total Patients Enrolled

Media Library

MitoQ Clinical Trial Eligibility Overview. Trial Name: NCT04334135 — N/A

High Blood Pressure Research Study Groups: MitoQ, Placebo

High Blood Pressure Clinical Trial 2023: MitoQ Highlights & Side Effects. Trial Name: NCT04334135 — N/A

MitoQ 2023 Treatment Timeline for Medical Study. Trial Name: NCT04334135 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this research?

"Affirmative. The details provided on clinicaltrials.gov demonstrate that the trial has been recruiting since October 2nd 2020 and is still doing so today, having last been updated on August 31st 2022. 60 participants are desired from a single location."

Answered by AI

Are there any opportunities currently available for participants in this trial?

"Indeed, the information on clinicaltrials.gov confirms that this trial is currently accepting participants. The initial post was made on October 2nd 2020 and the latest update was recorded on August 31st 2022; 60 individuals are being sought from a single site for enrollment."

Answered by AI

What are the main aims of this investigation?

"The principal outcome of this investigation will be changes in flow-mediated dilation (FMD) measured over a pre and post supplementation/placebo time frame. Secondary outcomes include mental health - social anxiety, assessed using the Liebowitz Social Anxiety Scale which ranges from 0 to 3; mental health - depression, evaluated with the Beck's Depression Inventory ranging also 0 to 3; as well as habitual dietary intake by completing a 6 day diet log utilizing Nutrition Data System for Research (NDSR)."

Answered by AI

What are the eligibility criteria for participating in this investigation?

"This trial is recruiting 60 individuals and targeting racial equity. The participants must be between 19-75 years old, with a healthy BMI of less than 35kg/m2, free from metabolic diseases or pulmonary disorders like COPD and cystic fibrosis, not current smokers nor having smoked within the past year, without any medical issue that would impede exercise or giving blood (e.g., blood thinners)."

Answered by AI