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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05872139
• Other study ID #: MitoQ
• Status: Completed
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: Ball State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 1, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Arterial Stiffness
• Cardiovascular Function
• Endothelial Dysfunction

Intervention

Dietary Supplement:
• Placebo
Gelatin capsules
• Mitoquinone Mesylate
MitoQ was given once (single dose, 80 mg)

Locations

Country	Name	City	State
United States	Ball State University	Muncie	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Ball State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vascular endothelial function	Brachial artery flow-mediated dilation (% [relative] and mm [absolute])	Baseline and Post 1 hour
Secondary	Change in cardiovascular function	Subendocardial viability ratio (%)	Baseline and Post 1 hour
Secondary	Change in Aortic Stiffness	Carotid-femoral pulse wave velocity (meters/second)	Baseline and Post 1 hour
Secondary	Change in carotid artery stiffness - beta-stiffness index	Carotid artery Beta stiffness index (AU)	Baseline and Post 1 hour
Secondary	Change in carotid artery compliance	Carotid artery compliance (mmHg/mm^2)	Baseline and Post 1 hour
Secondary	Change in carotid artery distensibility	Carotid artery distensibility (10^-3/kilopascals)	Baseline and Post 1 hour
Secondary	Change in carotid artery Young's elastic modulus	Carotid artery Young's elastic modulus (kilopascals, kPa)	Baseline and Post 1 hour