Skip to main content
OpenTrials
Completed

NCT Number: NCT05872139

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ball State University

Muncie, Indiana, 47306, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Gelatin capsules

Mitoquinone Mesylate

Dietary Supplement

MitoQ was given once (single dose, 80 mg)

Other names: MitoQ

Primary outcomes

  1. Change in vascular endothelial function

    Time frame: Baseline and Post 1 hour

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

Secondary outcomes

  1. Change in cardiovascular function

    Time frame: Baseline and Post 1 hour

    Subendocardial viability ratio (%)

  2. Change in Aortic Stiffness

    Time frame: Baseline and Post 1 hour

    Carotid-femoral pulse wave velocity (meters/second)

  3. Change in carotid artery stiffness - beta-stiffness index

    Time frame: Baseline and Post 1 hour

    Carotid artery Beta stiffness index (AU)

  4. Change in carotid artery compliance

    Time frame: Baseline and Post 1 hour

    Carotid artery compliance (mmHg/mm^2)

  5. Change in carotid artery distensibility

    Time frame: Baseline and Post 1 hour

    Carotid artery distensibility (10^-3/kilopascals)

  6. Change in carotid artery Young's elastic modulus

    Time frame: Baseline and Post 1 hour

    Carotid artery Young's elastic modulus (kilopascals, kPa)

Sponsors and collaborators

Lead sponsor

Ball State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.