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

NCT05872139 | Completed

• 1 other identifier: MitoQ
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Endothelial Dysfunction; Cardiovascular Function; Arterial Stiffness

Outcome Measures

Primary Outcomes (1)

• Change in vascular endothelial function

  Brachial artery flow-mediated dilation (% \[relative\] and mm \[absolute\])

  Baseline and Post 1 hour

Secondary Outcomes (6)

• Change in cardiovascular function

  Baseline and Post 1 hour

• Change in Aortic Stiffness

  Baseline and Post 1 hour

• Change in carotid artery stiffness - beta-stiffness index

  Baseline and Post 1 hour

• Change in carotid artery compliance

  Baseline and Post 1 hour

• Change in carotid artery distensibility

  Baseline and Post 1 hour

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Gelatin capsules

Dietary Supplement: Placebo

MitoQ

EXPERIMENTAL

Capsules containing mitoquinone mesylate (MitoQ, 5 mg/capsule) totaling 80 mg were taken once.

Dietary Supplement: Mitoquinone Mesylate

Interventions

Placebo DIETARY_SUPPLEMENT

Gelatin capsules

Placebo

Mitoquinone Mesylate DIETARY_SUPPLEMENT

MitoQ was given once (single dose, 80 mg)

Also known as: MitoQ

MitoQ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• cardiovascular/metabolic medications
• known clinical disease
• absolute contraindications to exercise testing

Sponsors & Collaborators

• Ball State University: lead

Study Sites (1)

Ball State University

Muncie, Indiana, 47306, United States

Location

MeSH Terms

Interventions

mitoquinone

Study Officials

• Brad Fleenor, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 24, 2023
• Study Start: September 23, 2022
• Primary Completion: April 17, 2023
• Study Completion: May 1, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)