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

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: Not yet recruiting
• Conditions: Aging; Postmenopause
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Mitoquinone (MitoQ)

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin Murray, PhD; Phone Number: (970) 491-3663; Email: fshn_tpl@colostate.edu

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80526
      • Translational Physiology Laboratory within the Food Science Clinical Research Laboratory
      • Contact: Kevin Murray, PhD; Phone Number: (970) 491-3663; Email: fshn_tpl@colostate.edu
      • Principal Investigator: Kevin Murray, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change from baseline in cerebrovascular conductance at 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

Outcome Measure	Measure Description	Time Frame
Change from baseline in cerebrovascular reactivity at 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	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	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	Cerebrovascular endothelium-dependent dilation	3 months
Change from baseline in mitochondrial oxidative stress-mediated suppression of internal carotid artery dilation at 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	The amount of blood flow feeding the brain at rest	3 months
Change from baseline in cerebrovascular stiffness at 3 months	Resting middle cerebral artery pulsatility index	3 months
Change from baseline in carotid artery compliance at 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	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

Outcome Measure	Measure Description	Time Frame
Change from baseline in serum exposure-induced arterial endothelial function at 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	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	Blood marker of oxidative stress	3 months

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: mitoquinone
• Other Study ID 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