What is the mechanism of action of this treatment?

Common treatments for aging, such as MitoQ, work by targeting oxidative stress and improving vascular function. MitoQ, a mitochondrial-targeted antioxidant, reduces oxidative stress within the mitochondria, which is a significant contributor to cellular aging and vascular dysfunction. By enhancing mitochondrial function and reducing oxidative damage, these treatments help maintain vascular health, which is crucial for aging patients. Improved vascular function can lead to better cardiovascular health, reduced risk of age-related diseases, and overall improved quality of life for older adults.

What side effects are associated with this type of intervention?

Common treatments for aging that target mitochondrial function and oxidative stress, such as MitoQ, generally aim to improve vascular health and reduce cardiovascular disease risk. Known side effects of these treatments can include mild gastrointestinal disturbances, headaches, and dizziness. In some cases, there may be more specific side effects related to the antioxidant properties, such as changes in liver enzyme levels or interactions with other medications. Overall, these treatments are typically well-tolerated, but long-term safety data are still being evaluated.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically targeting aging itself. However, several treatments focus on related conditions such as cardiovascular health and oxidative stress. Antioxidants like Coenzyme Q10 and drugs improving mitochondrial function have been explored, but none have received FDA approval specifically for aging. MitoQ, a mitochondrial-targeted antioxidant, is currently under study for its potential benefits in reducing oxidative stress and improving vascular function, particularly in postmenopausal women.

What other types of research exist?

Promising alternatives to MitoQ for reducing oxidative stress and improving vascular function in aging patients include: 1) Antioxidant compounds like Coenzyme Q10 (CoQ10) and Alpha-Lipoic Acid (ALA), which have shown potential in reducing oxidative stress. 2) Polyphenols such as Resveratrol, found in red wine, which have been studied for their vascular benefits. 3) NAD+ precursors like Nicotinamide Riboside (NR) and Nicotinamide Mononucleotide (NMN), which support mitochondrial function and have shown promise in preclinical and early clinical studies. 4) Angiotensin II receptor blockers (ARBs) and ACE inhibitors, which have vascular protective effects beyond their role in blood pressure management.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 10 weeks

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for aging, such as MitoQ, work by targeting oxidative stress and improving vascular function. MitoQ, a mitochondrial-targeted antioxidant, reduces oxidative stress within the mitochondria, which is a significant contributor to cellular aging and vascular dysfunction. By enhancing mitochondrial function and reducing oxidative damage, these treatments help maintain vascular health, which is crucial for aging patients. Improved vascular function can lead to better cardiovascular health, reduced risk of age-related diseases, and overall improved quality of life for older adults.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,752 Previous Clinical Trials

2,165,549 Total Patients Enrolled

20 Trials studying Aging

4,700 Patients Enrolled for Aging

National Institute on Aging (NIA)NIH

1,693 Previous Clinical Trials

28,027,185 Total Patients Enrolled

162 Trials studying Aging

80,025 Patients Enrolled for Aging

Kerrie L Moreau, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

3 Previous Clinical Trials

305 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

~13 spots leftby Dec 2024

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