The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of supplementation with the mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults.

Detailed Description
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Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.

Official Title
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The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults

Conditions
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Aging

Intervention / Treatment
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* Drug: MitoQ
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for >1 year. Ability to provide informed consent Baseline brachial flow-mediated dilation (FMD) < 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function. Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs) Willing to accept random assignment to condition Exclusion Criteria: Current smoking Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders Body mass index (BMI) >40 kg/m2 (FMD measurements can be inaccurate in severely obese patients) Chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive functions [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain diseases of aging]), except hypertension and hyperlipidemia Regular vigorous aerobic/endurance exercise (>3 vigorous bouts/week). Not weight stable in the prior 3 months (>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function. Current treatment or recent cessation (< 3 mo) of hormone replacement therapy Moderate or severe peripheral artery disease (ankle-brachial index <0.7). A graded exercise test will be performed by all subjects, if there is physician concern or an adverse event, the subject will not participate in a maximal oxygen consumption (VO2max) test (this will be determined in accordance with stated contraindications for exercise testing provided by the American Heart Association). Thyroid disease that is not controlled by medications or <3 month's use of a particular medication and/or dosage (uncontrolled thyroid diseases are associated with alterations in vascular function).

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MitoQ<br>MitoQ, 20 mg per day for six weeks | Drug: MitoQ<br>* Mitoquinone pill, 20 mg/day<br>* Other names: mitoquinone;Drug: Placebo<br>* Placebo pill with inert excipient, 1 time/day<br>* Other names: placebo pill;|
| Placebo Comparator: Placebo<br>Placebo, inert excipient, one time per day for six weeks | Drug: MitoQ<br>* Mitoquinone pill, 20 mg/day<br>* Other names: mitoquinone;Drug: Placebo<br>* Placebo pill with inert excipient, 1 time/day<br>* Other names: placebo pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelium-dependent dilation | Flow-mediated dilation | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic markers of oxidative stress | Oxidized LDL levels in blood. | 6 weeks | 
| Motor function | NIH Toolbox motor test battery | 6 weeks | 
| Cognitive function | NIH Toolbox cognition test battery | 6 weeks | 
| Arterial Stiffness | Aortic pulse wave velocity | 6 weeks | 
| Endothelial cell markers of oxidative stress | Nitrotyrosine levels in biopsied endothelial cells. | 6 weeks |