MitoQ + Exercise for Menopause-Related Vascular Health

(MITO-STEP Trial)

Overseen By Claire Cox, BA

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Colorado, Denver

Must not be taking: Antihypertensives, Lipid-lowering, Blood thinners

Disqualifiers: Diabetes, Cardiac disease, Renal, others

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a combination of aerobic exercise and MitoQ, an antioxidant supplement, might enhance heart and blood vessel health in postmenopausal women who cannot use estrogen. Researchers aim to determine if this combination can improve blood flow and reduce heart disease risks. Participants will be divided into groups to test different combinations: exercise with MitoQ, exercise with a placebo, or MitoQ without exercise. Ideal candidates are healthy, postmenopausal women who do not currently engage in vigorous exercise and are not using certain medications or supplements. As an Early Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants a chance to contribute to groundbreaking health advancements.

Will I have to stop taking my current medications?

You will need to stop taking any vitamin supplements or anti-inflammatory medications one month before joining the study and for its duration. Additionally, you cannot be on medications that might affect cardiovascular function, such as blood pressure or cholesterol-lowering drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MitoQ, a special antioxidant targeting the mitochondria in cells, is safe and well tolerated by adults. One study found that people taking MitoQ did not experience any serious side effects, suggesting it is generally safe for humans.

Aerobic exercise is also very safe. Studies indicate it can improve heart health and reduce stress. For postmenopausal women, exercise benefits heart and blood vessel health without causing harm.

In this trial, participants will use MitoQ, exercise, or a combination of both. Both treatments have a strong safety record and are expected to be well tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MitoQ for menopause-related vascular health because it offers a novel approach by targeting mitochondrial function. Unlike traditional treatments that may focus on hormone replacement or cardiovascular drugs, MitoQ uses mitoquinol mesylate to directly enhance mitochondrial efficiency, potentially improving energy production and reducing oxidative stress. This mechanism could lead to better vascular health outcomes with fewer systemic side effects. Additionally, when combined with aerobic exercise, MitoQ might amplify the positive effects on cardiovascular health, offering a complementary strategy to traditional exercise alone.

What evidence suggests that this trial's treatments could be effective for menopause-related vascular health?

Research has shown that MitoQ, a special antioxidant targeting the mitochondria, can improve blood vessel health by reducing harmful oxidative stress. Studies have found that MitoQ enhances blood vessel health in older adults by minimizing oxidative stress damage. Aerobic exercise, such as walking or cycling, has also improved blood vessel health in postmenopausal women by increasing oxygen use and enhancing blood flow. This trial will test the effects of MitoQ and aerobic exercise in separate treatment arms. One arm will combine MitoQ with aerobic exercise, while another will use aerobic exercise with a placebo. A third arm will test MitoQ without exercise. These findings suggest that using MitoQ along with aerobic exercise might further boost blood vessel health in postmenopausal women not on estrogen therapy. This combination could offer an alternative to traditional hormone treatments, potentially lowering the risk of heart disease. ^{1 3 4 5 6}

Who Is on the Research Team?

Kerrie L Moreau, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for healthy, sedentary or recreationally active postmenopausal women without hormone therapy for at least 6 months. Participants should have normal blood pressure and glucose levels, not be taking cardiovascular or certain other medications, and be non-smokers with a BMI under 40.

Inclusion Criteria

Fasted glucose <126 mg/dL

Sedentary/recreationally active (<2 days/wk vigorous exercise)

Nonsmokers

Exclusion Criteria

I do not have any physical issues that would stop me from joining an exercise program.

My thyroid is not functioning properly, but I might be eligible if it's treated.

I do not have any known allergies or adverse reactions to MitoQ or AE.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo moderate intensity aerobic exercise combined with oral MitoQ or placebo for 10 weeks

10 weeks

3 visits per week for exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic exercise
• MitoQ

Trial Overview The study tests if MitoQ (a type of antioxidant) combined with aerobic exercise improves vascular health in postmenopausal women better than exercise with a placebo or MitoQ alone. It's a 12-week test to see how well their arteries function after treatment.

How Is the Trial Designed?

Group I: No Exercise plus MitoQ Experimental Treatment 1 Intervention

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.

Group II: Aerobic Exercise plus MitoQ Experimental Treatment 2 Interventions

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.

Group III: Aerobic Exercise plus Placebo Placebo Group 2 Interventions

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.

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9261406/

Aerobic High-Intensity Exercise Training Improves ... The current study demonstrates that, in older post-menopausal women, a period of aerobic high intensity training effectively increases maximal oxygen uptake and ...

2. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03243-4

The impact of physical activity and exercise interventions on ... This overview assesses effectiveness of physical activity and exercise interventions targeting women experiencing menopause symptoms.

3. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/full/10.1113/EP092170

Vascular health and exercise in females throughout the lifespan Therefore, higher levels of physical activity in postmenopausal females appear to attenuate the vascular dysfunction that accompanies menopause.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378512214000255

To exercise, or, not to exercise, during menopause and ... Exercise has been assessed as an alternative treatment option for alleviating menopausal symptoms, including, psychological, vasomotor, somatic and sexual ...

5. frontiersin.org frontiersin.org/journals/reproductive-health/articles/10.3389/frph.2025.1542746/full

Impact of menopause hormone therapy, exercise, and their ... This review highlights that combining MHT and structured exercise is most effective for enhancing BMD in menopausal women.

6. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000912

Menopause Transition and Cardiovascular Disease Risk Data on physical activity, diet, and alcohol consumption and their associations with vasomotor symptoms occurrence are not consistent. Sleep Disturbance.