Mitochondrial-targeted Antioxidant Supplementation for Improving Age-related Vascular Dysfunction in Humans
NCT ID: NCT04851288
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
112 participants
INTERVENTIONAL
2021-04-02
2026-12-31
Brief Summary
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MitoQ is a mitochondria-targeted antioxidant that accumulates at the inner mitochondrial membrane where it is optimally positioned to reduce mtROS. Preclinical findings showed that 4 weeks of oral MitoQ supplementation completely restored EDD in old mice, ameliorated mtROS-associated suppression of EDD, and was associated with reduced arterial mtROS, oxidative stress, and improved mitochondrial health. MitoQ therapy also reduced aortic stiffness in old mice. A recent small pilot study of older adults (n=20) found that supplementation with MitoQ was well-tolerated, improved endothelial function, and reduced plasma levels of oxidized low-density lipoprotein, a circulating biomarker of oxidative stress. Consistent with the preclinical findings, preliminary mechanistic assessments in subsets of subjects from the pilot study suggested that improved endothelial function with MitoQ was mediated by reduced endothelial cell mtROS production, associated reductions in tonic mtROS-related suppression of EDD, and improved mitochondrial health, linked in part to changes in circulating factors in the serum induced by chronic MitoQ supplementation. Lastly, MitoQ reduced aortic stiffness in older adults who exhibited age-related aortic stiffening at baseline.
The investigators are conducting a randomized, placebo-controlled, double-blind clinical trial to establish oral MitoQ (20 mg/day; MitoQ, Ltd.) for 3 months vs. placebo (n=56/group) for improving endothelial function in older men and women (≥60 years), and determine the mechanisms by which MitoQ improves endothelial function. The investigators will also assess the effect of MitoQ on aortic stiffness.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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MitoQ, 20 mg/day
Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 3 months.
MitoQ
MitoQ is a biochemically modified form of ubiquinol
Placebo
Matched placebo capsules.
Placebo
Each placebo capsule contains inert excipient and is identical in appearance
Interventions
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MitoQ
MitoQ is a biochemically modified form of ubiquinol
Placebo
Each placebo capsule contains inert excipient and is identical in appearance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent
* Willing to accept random assignment to condition
* Body mass index \<40 kg/m2
* Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study
* Free from alcohol dependence or abuse,
* Mini-mental stage examination score ≥21
Exclusion Criteria
* Regular vigorous aerobic (\>6 bouts/week, \>60 min/bout at a workload \>6 METS)
* Blood donation within 8 weeks prior to enrolling in the study
60 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of Colorado, Boulder
OTHER
Responsible Party
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Douglas Seals
PI
Principal Investigators
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Douglas R Seals
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder
Locations
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University of Colorado Boulder
Boulder, Colorado, United States
Countries
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References
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Murray KO, Berryman-Maciel M, Darvish S, Coppock ME, You Z, Chonchol M, Seals DR, Rossman MJ. Mitochondrial-targeted antioxidant supplementation for improving age-related vascular dysfunction in humans: A study protocol. Front Physiol. 2022 Sep 15;13:980783. doi: 10.3389/fphys.2022.980783. eCollection 2022.
Other Identifiers
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20-0502
Identifier Type: -
Identifier Source: org_study_id