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CompletedNCT05872139Updated May 24, 2023

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

An interventional study of Placebo and Mitoquinone Mesylate in Aging, Endothelial Dysfunction and Cardiovascular Function, sponsored by Ball State University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Ball State University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2022, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Aging
  • Endothelial Dysfunction
  • Cardiovascular Function
  • Arterial Stiffness
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In context

Lead sponsor

Ball State University is the lead sponsor of 13 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • cardiovascular/metabolic medications
  • known clinical disease
  • absolute contraindications to exercise testing
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Gelatin capsules

    Dietary Supplement: Placebo

  • Experimental
    MitoQ

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

    Dietary Supplement: Mitoquinone Mesylate

Interventions

  • Dietary supplementPlacebo

    Gelatin capsules

  • Dietary supplementMitoquinone Mesylate

    MitoQ was given once (single dose, 80 mg)

    Also known as: MitoQ

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What researchers measure

Primary outcomes

  1. Change in vascular endothelial function

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

    Time frame: Baseline and Post 1 hour

Secondary outcomes

  1. Change in cardiovascular function

    Subendocardial viability ratio (%)

    Time frame: Baseline and Post 1 hour

  2. Change in Aortic Stiffness

    Carotid-femoral pulse wave velocity (meters/second)

    Time frame: Baseline and Post 1 hour

  3. Change in carotid artery stiffness - beta-stiffness index

    Carotid artery Beta stiffness index (AU)

    Time frame: Baseline and Post 1 hour

  4. Change in carotid artery compliance

    Carotid artery compliance (mmHg/mm\^2)

    Time frame: Baseline and Post 1 hour

  5. Change in carotid artery distensibility

    Carotid artery distensibility (10\^-3/kilopascals)

    Time frame: Baseline and Post 1 hour

  6. Change in carotid artery Young's elastic modulus

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

    Time frame: Baseline and Post 1 hour

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Study locations

1 site
  • Ball State University
    Muncie, Indiana 47306, United States
08

References and documents

Publications

  • Carlini NA, Harber MP, Fleenor BS. Acute effects of MitoQ on vascular endothelial function are influenced by cardiorespiratory fitness and baseline FMD in middle-aged and older adults. J Physiol. 2024 May;602(9):1923-1937. doi: 10.1113/JP285636. Epub 2024 Apr 3. PubMed 38568933 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05872139
Lead sponsor
Ball State University
Responsible party
Brad Fleenor (Associate Professor, Ball State University) — Principal investigator
First posted
May 24, 2023
Start date
Sep 23, 2022
Primary completion
Apr 17, 2023
Completion
May 1, 2023
Last update
May 24, 2023

Study contacts

Brad Fleenor, PhD
principal investigator · Associate Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Mitoquinone

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