AgingEarly Phase 1MITO-STEPNCT05686967
MitoQ and Exercise Effects on Vascular Health
A Early Phase 1 study testing MitoQ and Aerobic exercise in people with Aging and Menopause, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 120 years, women onlyHealthy volunteers can take part
- What is being tested?
- MitoQ and Aerobic exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2023to 30 Nov 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 120 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- resting blood pressure <140/90 mmHg;
- fasted glucose <126 mg/dL;
- sedentary/recreationally active (<2 days/wk vigorous exercise);
- healthy, as determined by medical history, physical examination, standard blood chemistries (chemistry panel, CBC and circulating thyroid levels) and ECG at rest and during exercise;
- nonsmokers;
- no use of medications that might influence cardiovascular function (i.e., antihypertensive, lipid lowering medications, blood thinners);
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- no use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior to enrollment and for the duration of the study;
- no use of HT for at least 6 months;
- body mass index <40kg/m2.
Who cannot join
- Volunteers will be excluded from the study if they have contraindications to MitoQ or AE.
- acute liver disease, history of venous thromboembolic events, preexisting or active cardiac, renal or hepatic disease, history of stomach ulcer or bleeding or epilepsy or other seizure disorder;
- diabetes, active infection, disease that affects the nervous system,
- an abnormal resting ECG, angina and/or ECG evidence of acute myocardial ischemia during the exercise test (development of ST-segment depression of more than 0.3 mV that is either horizontal, down-sloping, or slowly upsloping -less than 1 mvolt/sec and lasts more than 0.08 sec; ST elevation; chest pain or discomfort), bundle branch blocks, A-V block greater than first degree, arrhythmias;
- chronic infections;
- thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
- orthopedic or other problems that would interfere with participation in the exercise program
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory
Aurora, Colorado, 80045
About this study
Official title: MitoQ Supplementation for Restoring Aerobic Exercise Training Effects on Endothelial Function in Postmenopausal Women
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.
- Being tested
- MitoQ, Placebo, Aerobic exercise
- Keywords
- vascular health, exercise, oxidative stress
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQDietary supplement
Also called Mitoquinol
MitoQ is a biochemically modified form of ubiquinol
PlaceboDietary supplement
Each placebo capsule contains inert excipient and is identical in appearance
Aerobic exerciseBehavioural
Moderate intensity aerobic exercise on the treadmill
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise plus MitoQ | Experimental | 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. Receives: Dietary Supplement: MitoQ; Behavioral: Aerobic exercise |
| Aerobic Exercise plus Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo; Behavioral: Aerobic exercise |
| No Exercise plus MitoQ | Experimental | 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. Receives: Dietary Supplement: MitoQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Endothelial function at 10 weeks
Brachial artery flow-mediated dilation
Measured: Baseline and after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start16 Jan 2023
- Primary completion30 Sep 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kerrie L Moreau, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686967
- Sponsor's protocol ID
- 22-1521
- Other IDs
- R56AG072094
- Acronym
- MITO-STEP
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitoQ Supplementation for Restoring Aerobic Exercise Training Effects on Endothelial Function in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05686967
- Acronym / sponsor ID
- MITO-STEP / 22-1521
- Keywords
- vascular health, exercise, oxidative stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise plus MitoQ | Experimental | Dietary Supplement: MitoQ, Behavioral: Aerobic exerciseModerate 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. |
| Aerobic Exercise plus Placebo | Placebo comparator | Dietary Supplement: Placebo, Behavioral: Aerobic exerciseModerate 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. |
| No Exercise plus MitoQ | Experimental | Dietary Supplement: MitoQNo exercise plus experimental MitoQ, 20mg/d. Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 10 weeks. |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- resting blood pressure <140/90 mmHg;
- fasted glucose <126 mg/dL;
- sedentary/recreationally active (<2 days/wk vigorous exercise);
- healthy, as determined by medical history, physical examination, standard blood chemistries (chemistry panel, CBC and circulating thyroid levels) and ECG at rest and during exercise;
- nonsmokers;
Key exclusion criteria (8 listed)
- Volunteers will be excluded from the study if they have contraindications to MitoQ or AE.
- acute liver disease, history of venous thromboembolic events, preexisting or active cardiac, renal or hepatic disease, history of stomach ulcer or bleeding or epilepsy or other seizure disorder;
- diabetes, active infection, disease that affects the nervous system,
- an abnormal resting ECG, angina and/or ECG evidence of acute myocardial ischemia during the exercise test (development of ST-segment depression of more than 0.3 mV that is either horizontal, down-sloping, or slowly upsloping -less than 1 mvolt/sec and lasts more than 0.08 sec; ST elevation; chest pain or discomfort), bundle branch blocks, A-V block greater than first degree, arrhythmias;
- chronic infections;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitoQAlso: MitoquinolMitoQ is a biochemically modified form of ubiquinol | Dietary supplement | Aerobic Exercise plus MitoQ, No Exercise plus MitoQ |
| PlaceboEach placebo capsule contains inert excipient and is identical in appearance | Dietary supplement | Aerobic Exercise plus Placebo |
| Aerobic exerciseModerate intensity aerobic exercise on the treadmill | Behavioural | Aerobic Exercise plus MitoQ, Aerobic Exercise plus Placebo |
Primary outcome
Change from baseline Endothelial function at 10 weeks
Time frame: Baseline and after 10 weeks
Brachial artery flow-mediated dilation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerrie L Moreau, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MitoQ and Aerobic exercise in people with Aging and Menopause, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Endothelial function at 10 weeks (time frame: Baseline and after 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.