Oral Antioxidant Therapy Targeted to the Mitochondria for Improving Brain Artery Health in Postmenopausal Women

February 6, 2026 updated by: Colorado State University

Mitochondrial-Targeted Antioxidant Supplementation for Improving Cerebrovascular Function in Postmenopausal Women

The goal of this clinical trial is to learn if 3 months of taking the dietary supplement MitoQ [a mitochondria-targeted antioxidant that targets to reduce mitochondrial reactive oxygen species (mitoROS)] works to treat age- and menopause-related reductions in brain artery (cerebrovascular) function in postmenopausal women 60 years of age or older free of clinical disease. The main questions it aims to answer are:

Does MitoQ improve cerebrovascular function in postmenopausal women?

If so, does MitoQ improve cerebrovascular function by lowering mitoROS in these arteries?

Researchers will compare MitoQ to a placebo (a look-alike substance that contains no drug) to see if MitoQ can improve cerebrovascular function by lowering mitoROS in arteries involved in brain health and function.

Participants will:

Take MitoQ (20 mg/day) or a placebo every day for 3 months

Visit the research laboratory at baseline and then after 3 months for cerebrovascular testing; there is also a check-in visit at 6 weeks, which is the halfway point

Keep track of symptoms and events during their treatment period to report to the study team

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80526
        • Translational Physiology Laboratory within the Food Science Clinical Research Laboratory
        • Contact:
        • Principal Investigator:
          • Kevin Murray, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 60 years or older;
  • Postmenopausal women defined as at least 1 year without menses as self-reported;
  • Estrogen-deficient; no hormone therapies (e.g., estrogen, progesterone, testosterone, DHEA, oral contraceptives, etc.) within the previous 6 months;
  • Ability to provide informed consent;
  • Willing to accept random assignment to condition;
  • Body mass index (BMI) ≤35 kg/m2;
  • Mini-mental state examination score ≥21;
  • Weight stable in the prior 3 months;
  • Abstinence from antioxidant or CoQ10 therapy for 3 months; and
  • Absence of clinical disease as determined by the physician of record following a medical history and blood chemistries

Exclusion Criteria:

  • History of uncontrolled hypertension;
  • Currently meeting aerobic exercise guidelines of ≥75 mins/week of vigorous or ≥150 mins/week of moderate intensity exercise as assessed by Modified Activity Questionnaire;
  • Current smoker;
  • Alcohol dependence or abuse;
  • Other chronic medical conditions; and
  • Subject report of blood donation within 8 weeks prior to enrolling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Matched placebo capsules.
Dietary supplement: Placebo
Each placebo capsule contains inert excipient and is identical in appearance
Experimental: MitoQ, 20 mg/day
Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 3 months.
Dietary supplement: Mitoquinone (MitoQ)

MitoQ is a biochemically modified form of ubiquinol

Other Names:

Mitoquinol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in cerebrovascular conductance at 3 months
Time Frame: 3 months
Middle cerebral artery blood velocity in response to hypercapnia normalized for changes in end-tidal carbon dioxide and blood pressure
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in cerebrovascular reactivity at 3 months
Time Frame: 3 months
Middle cerebral artery blood velocity in response to hypercapnia normalized to changes in end-tidal carbon dioxide
3 months
Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular conductance at 3 months
Time Frame: 3 months
Cerebrovascular conductance to hypercapnia following administration of a supratherapeutic dose of MitoQ (160 mg) known to scavenge mitochondrial reactive oxygen species
3 months
Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular reactivity at 3 months
Time Frame: 3 months
Cerebrovascular reactviity to hypercapnia following administration of a supratherapeutic dose of MitoQ (160 mg) known to scavenge mitochondrial reactive oxygen species
3 months
Change from baseline in internal carotid artery dilation in response to hypercapnia at 3 months
Time Frame: 3 months
Cerebrovascular endothelium-dependent dilation
3 months
Change from baseline in mitochondrial oxidative stress-mediated suppression of internal carotid artery dilation at 3 months
Time Frame: 3 months
Internal carotid artery dilation to hypercapnia following administration of a supratherapeutic dose of MitoQ (160 mg) known to scavenge mitochondrial reactive oxygen species
3 months
Change from baseline in total cerebral blood flow at 3 months
Time Frame: 3 months
The amount of blood flow feeding the brain at rest
3 months
Change from baseline in cerebrovascular stiffness at 3 months
Time Frame: 3 months
Resting middle cerebral artery pulsatility index
3 months
Change from baseline in carotid artery compliance at 3 months
Time Frame: 3 months
Change in diameter of carotid artery for a given change in pressure
3 months
Change from baseline in mitochondrial oxidative stress-mediated suppression of carotid artery compliance at 3 months
Time Frame: 3 months
Carotid artery compliance following administration of a supratherapeutic dose of MitoQ (160 mg) known to scavenge mitochondrial reactive oxygen specie
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in serum exposure-induced arterial endothelial function at 3 months
Time Frame: 3 months
Donor mouse arterial endothelium-dependent dilation after treatment with serum from subjects
3 months
Change from baseline in serum exposure-induced arterial stiffness at 3 months
Time Frame: 3 months
Donor mouse arterial elastic modulus after treatment with serum from subjects
3 months
Change from baseline in circulating oxidized low-density lipoprotein at 3 months
Time Frame: 3 months
Blood marker of oxidative stress
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Colorado State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7559
  • K01HL177339 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will not be on a publicly available repository, however, any or all data may be made available upon reasonable request and collaboration.

IPD Sharing Time Frame

We will publish a study protocol paper within the first year of the study to enhance rigor and reproducibility of trial.

IPD Sharing Access Criteria

Those seeking access to the data with a research question and open for collaboration will be considered.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings