Oral Antioxidant Therapy Targeted to the Mitochondria for Improving Brain Artery Health in Postmenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mitoquinone (MitoQ), Placebo.
- Who it may be relevant to
- Registry conditions: Aging, Postmenopause. Basic parameters: from 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mitochondrial-Targeted Antioxidant Supplementation for Improving Cerebrovascular Function in Postmenopausal Women
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
Interventions
- Dietary supplement Mitoquinone (MitoQ)
MitoQ is a biochemically modified form of ubiquinol Other Names: Mitoquinol - Dietary supplement Placebo
Each placebo capsule contains inert excipient and is identical in appearance
Primary outcome measures
- Change from baseline in cerebrovascular conductance at 3 months [Time frame: 3 months]
Secondary outcome measures (9)
- Change from baseline in cerebrovascular reactivity at 3 months [Time frame: 3 months]
- Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular conductance at 3 months [Time frame: 3 months]
- Change from baseline in mitochondrial oxidative stress-mediated suppression of cerebrovascular reactivity at 3 months [Time frame: 3 months]
- Change from baseline in internal carotid artery dilation in response to hypercapnia at 3 months [Time frame: 3 months]
- Change from baseline in mitochondrial oxidative stress-mediated suppression of internal carotid artery dilation at 3 months [Time frame: 3 months]
- Change from baseline in total cerebral blood flow at 3 months [Time frame: 3 months]
- Change from baseline in cerebrovascular stiffness at 3 months [Time frame: 3 months]
- Change from baseline in carotid artery compliance at 3 months [Time frame: 3 months]
- Change from baseline in mitochondrial oxidative stress-mediated suppression of carotid artery compliance at 3 months [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Translational Physiology Laboratory within the Food Science Clinical Research Laboratory — Fort Collins
Identifiers
NCT: NCT07406243 · 7559 · K01HL177339