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MitoQ + Exercise for Menopause-Related Vascular Health (MITO-STEP Trial)

Phase < 1
Recruiting
Led By Kerrie L Moreau, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 10 weeks
Awards & highlights

MITO-STEP Trial Summary

This trial will investigate if moderate intensity exercise combined with MitoQ can improve vascular function and reduce CVD risk in postmenopausal women not using estrogen-based hormone therapy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the trial description does not specify side effects, potential ones may include typical reactions to supplements such as digestive discomfort. Exercise might cause muscle soreness or fatigue.

MITO-STEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline Endothelial function at 10 weeks
Other outcome measures
Change from baseline Serum exposure-induced endothelial cell nitric oxide production from at 10 weeks
Change from baseline in Change in Suppression of endothelial function by mitochondrial oxidative stress at 10 weeks
Change from baseline in Serum exposure-induced endothelial cell reactive oxygen species production at 10 weeks

MITO-STEP Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: No Exercise plus MitoQExperimental Treatment1 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 MitoQExperimental Treatment2 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 PlaceboPlacebo Group2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MitoQ
2006
Completed Phase 2
~230
Aerobic exercise
2000
Completed Phase 2
~1130

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,833 Total Patients Enrolled
19 Trials studying Aging
4,300 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,017,013 Total Patients Enrolled
160 Trials studying Aging
75,957 Patients Enrolled for Aging
Kerrie L Moreau, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
2 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Aging
155 Patients Enrolled for Aging

Media Library

Aerobic exercise Clinical Trial Eligibility Overview. Trial Name: NCT05686967 — Phase < 1
Aging Research Study Groups: Aerobic Exercise plus MitoQ, Aerobic Exercise plus Placebo, No Exercise plus MitoQ
Aging Clinical Trial 2023: Aerobic exercise Highlights & Side Effects. Trial Name: NCT05686967 — Phase < 1
Aerobic exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05686967 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age criteria for this research exclude individuals below 70 years?

"In keeping with the enrollment requirements for this medical trial, participants must be between 50 and 120 years old."

Answered by AI

How can I become a participant in this research endeavor?

"The eligibility criteria for this medical trial requires that participants are menopausal and between the ages of 50-120. The research team is looking to recruit a total of fifty people."

Answered by AI

Are there currently any vacant slots available for participants in this trial?

"This clinical trial is not presently recruiting. The original posting was on the 16th of January 2023, and it has been inactive since the 13th of that same month. However, 258 other studies are currently seeking candidates for their research projects."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
MitoQ and Exercise Effects on Vascular Health
2023. "MitoQ and Exercise Effects on Vascular Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05686967.
All > Menopause
~17 spots leftby Dec 2024
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