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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05872139
Enrollment
23
Registered
2023-05-24
Start date
2022-09-23
Completion date
2023-05-01
Last updated
2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Arterial Stiffness, Cardiovascular Function, Endothelial Dysfunction

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

Gelatin capsules

DIETARY_SUPPLEMENTMitoquinone Mesylate

MitoQ was given once (single dose, 80 mg)

Sponsors

Ball State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double-blind, placebo-controlled

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in vascular endothelial functionBaseline and Post 1 hourBrachial artery flow-mediated dilation (% \[relative\] and mm \[absolute\])

Secondary

MeasureTime frameDescription
Change in carotid artery stiffness - beta-stiffness indexBaseline and Post 1 hourCarotid artery Beta stiffness index (AU)
Change in cardiovascular functionBaseline and Post 1 hourSubendocardial viability ratio (%)
Change in Aortic StiffnessBaseline and Post 1 hourCarotid-femoral pulse wave velocity (meters/second)
Change in carotid artery distensibilityBaseline and Post 1 hourCarotid artery distensibility (10\^-3/kilopascals)
Change in carotid artery Young's elastic modulusBaseline and Post 1 hourCarotid artery Young's elastic modulus (kilopascals, kPa)
Change in carotid artery complianceBaseline and Post 1 hourCarotid artery compliance (mmHg/mm\^2)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026