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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL177339 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitoQ, 20 mg/day | Experimental | Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 3 months. |
|
| Placebo | Placebo Comparator | Matched placebo capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoquinone (MitoQ) | Dietary Supplement | MitoQ is a biochemically modified form of ubiquinol Other Names: Mitoquinol |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Murray, PhD | Contact | (970) 491-3663 | fshn_tpl@colostate.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Physiology Laboratory within the Food Science Clinical Research Laboratory | Fort Collins | Colorado | 80526 | United States |
The IPD will not be on a publicly available repository, however, any or all data may be made available upon reasonable request and collaboration.
We will publish a study protocol paper within the first year of the study to enhance rigor and reproducibility of trial.
Those seeking access to the data with a research question and open for collaboration will be considered.
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| ID | Term |
|---|---|
| C429014 | mitoquinone |
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| Placebo | Dietary Supplement | Each placebo capsule contains inert excipient and is identical in appearance |
|
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 |
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 |