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

Not Applicable

Completed

• Conditions: Aging; Arterial Stiffness; Endothelial Dysfunction; Cardiovascular Function
• Interventions: Dietary Supplement: Mitoquinone Mesylate; Dietary Supplement: Placebo

• Registration Number: NCT05872139
• Lead Sponsor: Ball State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-23
• Primary Completion: 2023-04-17
• Status Verified: 2023-05
• Study Completion: 2023-05-01
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MitoQ	Mitoquinone Mesylate	Capsules containing mitoquinone mesylate (MitoQ, 5 mg/capsule) totaling 80 mg were taken once.
Placebo	Placebo	Gelatin capsules

Primary Outcome Measures

Name	Time	Method
Change in vascular endothelial function	Baseline and Post 1 hour	Brachial artery flow-mediated dilation (% \[relative\] and mm \[absolute\])

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ball State University; 🇺🇸 Muncie, Indiana, United States