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NCT05686967 · ClinicalTrials.gov registry record · Early Phase 1
MitoQ and Exercise Effects on Vascular Health
A Early Phase 1 study of Aging and Menopause, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05686967: Active Early Phase 1 study of Aging and Menopause, sponsored by University of Colorado, Denver.
NCT05686967 is a Early Phase 1 study of Aging and Menopause that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 22 participants, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05686967, a Early Phase 1 study of Aging and Menopause, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
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 greate
Primary Outcome
Brachial artery flow-mediated dilation
Interventions
- DIETARY_SUPPLEMENT Placebo
- BEHAVIORAL Aerobic exercise
- DIETARY_SUPPLEMENT MitoQ
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-01-16 |
| Est. Completion | 2025-11-30 |
| Phase | Early Phase 1 |
What the registry record for NCT05686967 still lists
NCT05686967 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Aging appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05686967 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05686967 about?
NCT05686967 is a clinical study titled "MitoQ and Exercise Effects on Vascular Health". 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 improvem...
What is the current status of trial NCT05686967?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2023-01-16. Estimated completion is 2025-11-30.
What conditions does trial NCT05686967 study?
This clinical trial studies the following conditions: Aging, Menopause.
What interventions are being tested in trial NCT05686967?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Aerobic exercise (BEHAVIORAL), MitoQ (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05686967?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05686967 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05686967's enrollment target sits among peer trials
22 226th of 262 higher than 33 of 262 other Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aging trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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