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Clinical Trials/NCT05872139
NCT05872139CompletedNot Applicable

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

Ball State University1 site in 1 country23 target enrollmentStarted: September 23, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
1
Primary Endpoint
Change in vascular endothelial function

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Double-blind, placebo-controlled

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Placebo

Placebo Comparator

Gelatin capsules

Intervention: Placebo (Dietary Supplement)

MitoQ

Experimental

Capsules containing mitoquinone mesylate (MitoQ, 5 mg/capsule) totaling 80 mg were taken once.

Intervention: Mitoquinone Mesylate (Dietary Supplement)

Outcomes

Primary Outcomes

Change in vascular endothelial function

Time Frame: Baseline and Post 1 hour

Brachial artery flow-mediated dilation (% \[relative\] and mm \[absolute\])

Secondary Outcomes

  • Change in carotid artery Young's elastic modulus(Baseline and Post 1 hour)
  • Change in carotid artery compliance(Baseline and Post 1 hour)
  • Change in carotid artery stiffness - beta-stiffness index(Baseline and Post 1 hour)
  • Change in cardiovascular function(Baseline and Post 1 hour)
  • Change in Aortic Stiffness(Baseline and Post 1 hour)
  • Change in carotid artery distensibility(Baseline and Post 1 hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brad Fleenor

Associate Professor

Ball State University

Study Sites (1)

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