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

N/ANot Yet RecruitingNCT07406243

Colorado State University86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Aging Postmenopause

Eligibility

Sex: FEMALEMin age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 3 months

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

Cerebrovascular endothelium-dependent dilation

Time frame: 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

Time frame: 3 months

Change from baseline in total cerebral blood flow at 3 months

The amount of blood flow feeding the brain at rest

Time frame: 3 months

Change from baseline in cerebrovascular stiffness at 3 months

Resting middle cerebral artery pulsatility index

Time frame: 3 months

Change from baseline in carotid artery compliance at 3 months

Change in diameter of carotid artery for a given change in pressure

Time frame: 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

Time frame: 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts