An Early Phase 1 interventional study of MitoQ and Placebo in Aging and Menopause, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in United States. Open to female participants aged 50 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by University of Colorado, Denver · Early Phase 1, Interventional, and Basic science
An impairment in vascular function can lead to the development of age-associated cardiovascular disease (CVD), the leading cause of death in postmenopausal women. Regular aerobic exercise (AE) benefits vascular function in older men by reducing oxidative stress, however, similar AE training improvements are diminished or absent in postmenopausal women. not using estrogen-based hormone therapy. Vascular function and oxidative stress are improved with AE training in postmenopausal women treated with E2, suggesting an essential role of E2 in vascular adaptations to AE in women. Clinical use of E2 is contraindicated for this purpose, thus establishing alternative pharmacological approaches that could be administered as a substitute for E2 to improve AE signaling for vascular benefits and reducing CVD risk in E2-deficient postmenopausal women is biomedically important. The mitochondrial-targeted antioxidant MitoQ may be an alternative to E2 for restoring AE benefits in E2-deficient postmenopausal women given its recently established effectiveness for reducing oxidative stress and improving vascular function in that population. Accordingly, the overall aim of this application is to assess the efficacy of a 12-week randomized controlled trial of moderate intensity AE training combined with oral MitoQ (20 mg/d) compared to AE+oral placebo (PL) or No AE+MitoQ on vascular vasodilatory function (brachial artery flow-mediated dilation; FMD) in healthy E2-deficient postmenopausal women. Insight into the causes for the improvement related to molecules (e.g., nitric oxide) that promote vasodilation, mitochondrial function, oxidative stress, and the influence of "circulating factors" will also be obtained. We hypothesize that AE+MitoQ will improve both FMD > AE+PL and > No AE+MitoQ, and that No AE+MitoQ will improve FMD > AE+PL. The greater improvements in endothelial function with AE+MitoQ vs. both AE+PL and No AE+MitoQ, and with No AE+MitoQ vs. AE+PL will be mediated by greater improvements in nitric oxide production, mitochondrial function, and mitochondrial and oxidative stress linked, at least in part, to changes in "circulating factors". The expected results from this study will establish the efficacy of MitoQ for restoring AE-vascular signaling in E2-deficient postmenopausal women and will provide the foundation for development of evidence-based guidelines for sex-specific AE programs for improving vascular health and preventing CVD in postmenopausal women.
University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The volunteers who choose to participate will do so with the understanding that they will be randomly assigned to study groups that involve either AE+PL (33% chance), No AE+MitoQ (33% chance) or AE+MitoQ (33% chance).
Moderate intensity aerobic exercise, 50 minutes of treadmill exercise, 65-75% of maximal heart rate, 3 d/week for 10 weeks plus experimental MitoQ, 20mg/d. Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 10 weeks.
Dietary Supplement: MitoQ · Behavioral: Aerobic exercise
Moderate intensity aerobic exercise, 50 minutes of treadmill exercise, 65-75% of maximal heart rate, 3 d/week for 10 weeks plus matching placebo capsule/d for 10 weeks. Matched placebo capsules.
Dietary Supplement: Placebo · Behavioral: Aerobic exercise
No exercise plus experimental MitoQ, 20mg/d. Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 10 weeks.
Dietary Supplement: MitoQ
MitoQ is a biochemically modified form of ubiquinol
Also known as: Mitoquinol
Each placebo capsule contains inert excipient and is identical in appearance
Moderate intensity aerobic exercise on the treadmill
Change from baseline Endothelial function at 10 weeks
Brachial artery flow-mediated dilation
Time frame: Baseline and after 10 weeks
Change from baseline in Change in Suppression of endothelial function by mitochondrial oxidative stress at 10 weeks
Change in brachial artery flow-mediated dilation with acute supratherapeutic MitoQ dosed at 160mg
Time frame: Baseline and 10 weeks
Change from baseline in Serum exposure-induced endothelial cell reactive oxygen species production at 10 weeks
Endothelial cell whole-cell (CellROX) and mitochondria-specific (MitoSOX) reactive oxygen species levels after treatment with serum from subjects
Time frame: Baseline and 10 weeks
Change from baseline Serum exposure-induced endothelial cell nitric oxide production from at 10 weeks
Endothelial cell DAF-FM before and after addition of 200 µM Ach will quantify the capacity of HUVECs to generate nitric oxide after treatment with serum from subjects
Time frame: Baseline and 10 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver