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

NCT ID: NCT05872139

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-23

Study Completion Date

2023-05-01

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.

Detailed Description

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Conditions

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Aging Endothelial Dysfunction Cardiovascular Function Arterial Stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double-blind, placebo-controlled

Study Groups

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Placebo

Gelatin capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Gelatin capsules

MitoQ

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

Group Type EXPERIMENTAL

Mitoquinone Mesylate

Intervention Type DIETARY_SUPPLEMENT

MitoQ was given once (single dose, 80 mg)

Interventions

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Placebo

Gelatin capsules

Intervention Type DIETARY_SUPPLEMENT

Mitoquinone Mesylate

MitoQ was given once (single dose, 80 mg)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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MitoQ

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ball State University

OTHER

Sponsor Role lead

Responsible Party

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Brad Fleenor

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brad Fleenor, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Ball State University

Muncie, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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MitoQ

Identifier Type: -

Identifier Source: org_study_id

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