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

NCT07406243 | Not Yet Recruiting DMC

• 2 other identifiers: 7559K01HL177339
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Aging; Postmenopause

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from baseline in cerebrovascular reactivity at 3 months

  3 months

• Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular conductance at 3 months

  3 months

• Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular reactivity at 3 months

  3 months

• Change from baseline in internal carotid artery dilation in response to hypercapnia at 3 months

  3 months

• Change from baseline in mitochondrial oxidative stress-mediated suppression of internal carotid artery dilation at 3 months

  3 months

Other Outcomes (3)

• Change from baseline in serum exposure-induced arterial endothelial function at 3 months

  3 months

• Change from baseline in serum exposure-induced arterial stiffness at 3 months

  3 months

• Change from baseline in circulating oxidized low-density lipoprotein at 3 months

  3 months

Study Arms (2)

MitoQ, 20 mg/day

EXPERIMENTAL

Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 3 months.

Dietary Supplement: Mitoquinone (MitoQ)

Placebo

PLACEBO COMPARATOR

Matched placebo capsules.

Dietary Supplement: Placebo

Interventions

Mitoquinone (MitoQ) DIETARY_SUPPLEMENT

MitoQ is a biochemically modified form of ubiquinol Other Names: Mitoquinol

MitoQ, 20 mg/day

Placebo DIETARY_SUPPLEMENT

Each placebo capsule contains inert excipient and is identical in appearance

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Translational Physiology Laboratory within the Food Science Clinical Research Laboratory

Fort Collins, Colorado, 80526, United States

Location

MeSH Terms

Interventions

mitoquinone

Central Study Contacts

Kevin Murray, PhD

CONTACT

(970) 491-3663; fshn_tpl@colostate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We will publish a study protocol paper within the first year of the study to enhance rigor and reproducibility of trial.
• Access Criteria: Those seeking access to the data with a research question and open for collaboration will be considered.

Locations

US (1)