Role of Mitochondrial-derived Oxidative Stress to Promote Vascular Endothelial Dysfunction in Non-exercisers With Aging

Study Overview
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Brief Summary
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The primary goal of this intervention is to determine the efficacy of acute mitochondrial-specific antioxidants to improve vascular endothelial function in middle-aged and older (≥45 y) adults who do no perform regular aerobic exercise. In a double-blind, randomized, placebo-controlled crossover design participants with receive both MitoQ and placebo arm of the study. Primary endpoints will include vascular endothelial function assessed by brachial artery flow-mediated dilation and cardiac function assessed via pulse wave analysis. Secondary endpoints will include measures of aortic stiffness assessed by carotid-femoral pulse wave velocity and carotid artery stiffness (e.g. β-stiffness) and elasticity (carotid compliance, distensibility, and Youngs elastic modulus) from ultrasonography.

Official Title
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Influence of Exercise/Cardiorespiratory Fitness on Enhanced Endothelial Function With Aging: Role of Mitochondrial-derived Oxidative Stress

Conditions
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Aging, Endothelial Dysfunction, Cardiovascular Function, Arterial Stiffness

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Mitoquinone Mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resting brachial blood pressure <160 mmHg (systolic)/<100 mmHg (diastolic) Body mass index ≤ 35 kg/m2 Nonsmoker Women must be postmenopausal defined as cessation of menses ≥ 1 year. Exclusion Criteria: cardiovascular/metabolic medications known clinical disease absolute contraindications to exercise testing

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Gelatin capsules | Dietary Supplement: Placebo<br>* Gelatin capsules<br>|
| Experimental: MitoQ<br>Capsules containing mitoquinone mesylate (MitoQ, 5 mg/capsule) totaling 80 mg were taken once. | Dietary Supplement: Mitoquinone Mesylate<br>* MitoQ was given once (single dose, 80 mg)<br>* Other names: MitoQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vascular endothelial function | Brachial artery flow-mediated dilation (% [relative] and mm [absolute]) | Baseline and Post 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiovascular function | Subendocardial viability ratio (%) | Baseline and Post 1 hour | 
| Change in Aortic Stiffness | Carotid-femoral pulse wave velocity (meters/second) | Baseline and Post 1 hour | 
| Change in carotid artery stiffness - beta-stiffness index | Carotid artery Beta stiffness index (AU) | Baseline and Post 1 hour | 
| Change in carotid artery compliance | Carotid artery compliance (mmHg/mm^2) | Baseline and Post 1 hour | 
| Change in carotid artery distensibility | Carotid artery distensibility (10^-3/kilopascals) | Baseline and Post 1 hour | 
| Change in carotid artery Young's elastic modulus | Carotid artery Young's elastic modulus (kilopascals, kPa) | Baseline and Post 1 hour |