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

Sponsor
Ball State University (Other)
Overall Status
Completed
CT.gov ID
NCT05872139
Collaborator
(none)
23
Enrollment
1
Location
2
Arms
7.2
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo
  • Dietary Supplement: Mitoquinone Mesylate
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double-blind, placebo-controlled
Primary Purpose:
Other
Official Title:
Influence of Exercise/Cardiorespiratory Fitness on Enhanced Endothelial Function With Aging: Role of Mitochondrial-derived Oxidative Stress
Actual Study Start Date :
Sep 23, 2022
Actual Primary Completion Date :
Apr 17, 2023
Actual Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Gelatin capsules

Dietary Supplement: Placebo
Gelatin capsules
Experimental: MitoQ

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

Dietary Supplement: Mitoquinone Mesylate
MitoQ was given once (single dose, 80 mg)
Other Names:
  • MitoQ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in vascular endothelial function [Baseline and Post 1 hour]

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

    Secondary Outcome Measures

    1. Change in cardiovascular function [Baseline and Post 1 hour]

      Subendocardial viability ratio (%)

    2. Change in Aortic Stiffness [Baseline and Post 1 hour]

      Carotid-femoral pulse wave velocity (meters/second)

    3. Change in carotid artery stiffness - beta-stiffness index [Baseline and Post 1 hour]

      Carotid artery Beta stiffness index (AU)

    4. Change in carotid artery compliance [Baseline and Post 1 hour]

      Carotid artery compliance (mmHg/mm^2)

    5. Change in carotid artery distensibility [Baseline and Post 1 hour]

      Carotid artery distensibility (10^-3/kilopascals)

    6. Change in carotid artery Young's elastic modulus [Baseline and Post 1 hour]

      Carotid artery Young's elastic modulus (kilopascals, kPa)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ball State University Muncie Indiana United States 47306

    Sponsors and Collaborators

    • Ball State University

    Investigators

    • Principal Investigator: Brad Fleenor, PhD, Associate Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brad Fleenor, Associate Professor, Ball State University
    ClinicalTrials.gov Identifier:
    NCT05872139
    Other Study ID Numbers:
    • MitoQ
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 24, 2023