Aging Clinical Trial
Official title:
Influence of Exercise/Cardiorespiratory Fitness on Enhanced Endothelial Function With Aging: Role of Mitochondrial-derived Oxidative Stress
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 |
Verified date | May 2023 |
Source | Ball State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Ball State University | Muncie | Indiana |
Lead Sponsor | Collaborator |
---|---|
Ball State University |
United States,
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 |
Status | Clinical Trial | Phase | |
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