MitoQ + Exercise for Menopause-Related Vascular Health

(MITO-STEP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Kerrie L Moreau, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Colorado, Denver

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.

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.

Treatment Details

Interventions

• Aerobic exercise (Behavioral)
• MitoQ (Mitochondrial-targeted antioxidant)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Colorado Anschutz Medical Center, Clinical Translational Research Center and Exercise Research Laboratory Aurora, CO

Who Is Running the Clinical Trial?

University of Colorado, Denver Lead Sponsor

National Institute on Aging (NIA) Collaborator

References