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

NCT07406243 — Not applicable, Not yet recruiting, 86 participants, Colorado State University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07406243
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	86 (Estimated)
Sponsor	Colorado State University (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Aging, Postmenopause
Interventions	Mitoquinone (MitoQ), Placebo (Dietary supplement)
Dates	start 2026-04-01 (estimated), primary completion 2030-01-01 (estimated), completion 2030-07-01 (estimated), first posted 2026-02-12, last updated 2026-02-12
Locations	1 site in United States

-Summary

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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
MitoQ, 20 mg/day	Experimental	Dietary Supplement: Mitoquinone (MitoQ)	Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 3 months.
Placebo	Placebo comparator	Dietary Supplement: Placebo	Matched placebo capsules.

Mitoquinone (MitoQ) (Dietary supplement): MitoQ is a biochemically modified form of ubiquinol Other Names: Mitoquinol
Placebo (Dietary supplement): Each placebo capsule contains inert excipient and is identical in appearance

+Outcome measures

Primary outcomes

Change from baseline in cerebrovascular conductance at 3 months [3 months]: Middle cerebral artery blood velocity in response to hypercapnia normalized for changes in end-tidal carbon dioxide and blood pressure

Secondary outcomes

Change from baseline in cerebrovascular reactivity at 3 months [3 months]: Middle cerebral artery blood velocity in response to hypercapnia normalized to changes in end-tidal carbon dioxide
Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular conductance at 3 months [3 months]: Cerebrovascular conductance to hypercapnia following administration of a supratherapeutic dose of MitoQ (160 mg) known to scavenge mitochondrial reactive oxygen species
Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular reactivity at 3 months [3 months]: Cerebrovascular reactviity to hypercapnia following administration of a supratherapeutic dose of MitoQ (160 mg) known to scavenge mitochondrial reactive oxygen species
Change from baseline in internal carotid artery dilation in response to hypercapnia at 3 months [3 months]: Cerebrovascular endothelium-dependent dilation
Change from baseline in mitochondrial oxidative stress-mediated suppression of internal carotid artery dilation at 3 months [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
Change from baseline in total cerebral blood flow at 3 months [3 months]: The amount of blood flow feeding the brain at rest
Change from baseline in cerebrovascular stiffness at 3 months [3 months]: Resting middle cerebral artery pulsatility index
Change from baseline in carotid artery compliance at 3 months [3 months]: Change in diameter of carotid artery for a given change in pressure
Change from baseline in mitochondrial oxidative stress-mediated suppression of carotid artery compliance at 3 months [3 months]: Carotid artery compliance following administration of a supratherapeutic dose of MitoQ (160 mg) known to scavenge mitochondrial reactive oxygen specie

Other outcomes

Change from baseline in serum exposure-induced arterial endothelial function at 3 months [3 months]: Donor mouse arterial endothelium-dependent dilation after treatment with serum from subjects
Change from baseline in serum exposure-induced arterial stiffness at 3 months [3 months]: Donor mouse arterial elastic modulus after treatment with serum from subjects
Change from baseline in circulating oxidized low-density lipoprotein at 3 months [3 months]: Blood marker of oxidative stress

+Eligibility

Sex: Female, ages: 60 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Translational Physiology Laboratory within the Food Science Clinical Research Laboratory	Fort Collins, Colorado	United States

+Funding

NIH grants: K01HL177339