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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05872139
Other study ID # MitoQ
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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