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

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether combining moderate aerobic exercise with the antioxidant MitoQ can improve blood vessel function in postmenopausal women who lack estrogen. MitoQ aims to reduce oxidative stress and enhance blood flow by improving mitochondrial function. The study will compare the effects of exercise with MitoQ, exercise alone, and MitoQ alone. MitoQ is a mitochondria-targeted antioxidant that has been studied for its potential to enhance exercise-induced muscle adaptations and improve peak power in untrained middle-aged men.

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.

What data supports the effectiveness of the treatment MitoQ + Exercise for menopause-related vascular health?

Research shows that regular exercise can improve cardiovascular health in postmenopausal women, and treatments like estradiol can enhance these benefits. While MitoQ specifically isn't mentioned, similar treatments have shown positive effects on heart health. ^{1 2 3 4 5}

Is MitoQ and exercise safe for menopause-related vascular health?

The research does not provide specific safety data for MitoQ, but aerobic exercise is generally considered safe and can reduce oxidative stress (damage caused by free radicals) in postmenopausal women, whether or not they use hormone replacement therapy. ^{3 6 7 8 9}

How does the MitoQ + Exercise treatment for menopause-related vascular health differ from other treatments?

The MitoQ + Exercise treatment is unique because it combines aerobic exercise with MitoQ, a supplement that targets mitochondria (the energy-producing parts of cells) to potentially improve vascular health. This approach is different from other treatments like hormone replacement therapy or dietary supplements, as it specifically focuses on enhancing cellular energy and reducing oxidative stress, which may help improve blood vessel function in postmenopausal women. ^{1 2 6 8 10}

Research Team

Kerrie L Moreau, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of resveratrol or estradiol on postexercise endothelial function in estrogen-deficient postmenopausal women. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Moderate intensity walking exercises reduce the body mass index and vascular inflammatory factors in postmenopausal women with obesity: a randomized controlled trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Oral estrogen therapy may mitigate the effects of aerobic training on cardiorespiratory fitness in postmenopausal women: a double-blind, randomized clinical pilot study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Resistance training decreases plasma levels of adipokines in postmenopausal women. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

Combined effect of physical exercise and hormone replacement therapy on cardiovascular and metabolic health in postmenopausal women: A systematic review and meta-analysis. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Beetroot supplementation in women enjoying exercise together (BEE SWEET): Rationale, design and methods. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Oxidative stress levels are reduced in postmenopausal women with exercise training regardless of hormone replacement therapy status. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Moderate and heavy oxygen uptake kinetics in postmenopausal women. [2016]

9. England pubmed.ncbi.nlm.nih.gov

The superior beneficial effects of exercise training versus hormone replacement therapy on skeletal muscle of ovariectomized rats. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of menopause and exercise training on plasma apolipoprotein M and sphingosine-1-phosphate. [2020]