60 Participants Needed

MitoQ for Peripheral Arterial Disease

HD
Overseen ByHolly DeSpiegelaere, BSN RN CCRC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your blood pressure, lipid, and diabetes treatments remain stable for 6 weeks before joining.

Is MitoQ safe for human use?

Research indicates that MitoQ, a mitochondrial-targeted antioxidant, is generally safe in humans. Studies have shown that even at high doses, MitoQ does not increase markers of kidney injury in healthy adults, suggesting it is well-tolerated.12345

How does the drug MitoQ differ from other treatments for peripheral arterial disease?

MitoQ is unique because it is a mitochondrial-targeted antioxidant that improves vascular function by enhancing the health of mitochondria in blood vessels, which can lead to better walking capacity and reduced leg pain in patients with peripheral arterial disease.16789

What is the purpose of this trial?

In our research, we are delving into whether taking MitoQ for six months can improve the symptoms and function of people diagnosed with peripheral artery disease, especially those who suffer from leg pain while walking, known as intermittent claudication. We will be checking if MitoQ helps people with claudication walk better, be more active every day, feel better about their lives, and if it enhances the health of their leg muscles.

Research Team

IP

Iraklis Pipinos, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for individuals with peripheral artery disease (PAD) or peripheral vascular disease (PVD), who experience leg pain while walking. Participants should be willing to undergo various assessments, including muscle oxygen tests, walking evaluations, quality of life surveys, ankle pressure measurements, and a needle biopsy.

Inclusion Criteria

I have a history of leg pain when walking.
I have been diagnosed with blocked arteries in my legs.
Exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon
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Exclusion Criteria

I have severe leg pain or tissue loss because of poor blood flow.
My ability to walk is mainly limited by non-claudication issues like joint, nerve, or systemic diseases.
I recently had a blockage in the blood flow to my legs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 24-week regimen of oral dosing with MitoQ or placebo

24 weeks
Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • MitoQ
Trial Overview The study investigates whether MitoQ supplementation over six months can improve walking ability and daily activity levels in PAD patients with intermittent claudication. It also examines the impact on muscle health and overall quality of life.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: MitoQActive Control6 Interventions
Participants will be placed on a 24-week regimen of oral dosing with MitoQ. The patients will take two 20 mg caps of MitoQ on empty stomach, each morning
Group II: PlaceboPlacebo Group6 Interventions
The patients will take two identical caps of matched placebo on empty stomach, each morning

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

Findings from Research

Acute intake of the mitochondrial-targeted antioxidant MitoQ significantly improved vascular endothelial function and increased superoxide dismutase levels in patients with peripheral artery disease (PAD), based on a study involving 11 participants.
MitoQ also enhanced walking capacity and delayed the onset of claudication, suggesting it may effectively restore mitochondrial function and improve overall leg performance in PAD patients.
Acute mitochondrial antioxidant intake improves endothelial function, antioxidant enzyme activity, and exercise tolerance in patients with peripheral artery disease.Park, SY., Pekas, EJ., Headid, RJ., et al.[2021]
In a study involving 50 male Wistar rats, the mitochondrial-targeted antioxidant MitoQ significantly improved survival rates (80%) and reduced tumor incidence (by 60% and 40% in different treatment groups) compared to those treated with diethyl nitrosamine (DEN) alone, indicating its potential as a protective agent against liver cancer.
MitoQ treatment also enhanced liver function and mitochondrial enzyme activities while reversing oxidative damage, suggesting that it effectively modulates mitochondrial antioxidant defenses and may serve as a promising chemotherapeutic agent in the context of DEN-induced hepatocellular carcinoma.
Mitoquinol mesylate (MITOQ) attenuates diethyl nitrosamine-induced hepatocellular carcinoma through modulation of mitochondrial antioxidant defense systems.Adisa, RA., Sulaimon, LA., Okeke, EG., et al.[2023]
Acute high-dose MitoQ supplementation (100-160 mg) in 32 healthy adults showed no significant changes in urinary biomarkers associated with kidney injury, suggesting it is not nephrotoxic.
The study's results support the safety of MitoQ for further research on its effects related to mitochondrial oxidative stress, as it did not affect kidney function or injury markers in the short term.
Acute High Dose MitoQ Does not Increase Urinary Kidney Injury Markers in Healthy Adults.Linder, BA., Stute, NL., Hutchison, ZJ., et al.[2023]

References

Acute mitochondrial antioxidant intake improves endothelial function, antioxidant enzyme activity, and exercise tolerance in patients with peripheral artery disease. [2021]
Mitoquinol mesylate (MITOQ) attenuates diethyl nitrosamine-induced hepatocellular carcinoma through modulation of mitochondrial antioxidant defense systems. [2023]
Acute High Dose MitoQ Does not Increase Urinary Kidney Injury Markers in Healthy Adults. [2023]
Transport and metabolism of MitoQ10, a mitochondria-targeted antioxidant, in Caco-2 cell monolayers. [2018]
Association of Anticoagulation and Major Adverse Limb Events After Index Peripheral Endovascular Intervention. [2023]
The peripheral artery questionnaire: a new disease-specific health status measure for patients with peripheral arterial disease. [2022]
Assessment of Minimum Important Difference and Substantial Clinical Benefit with the Vascular Quality of Life Questionnaire-6 when Evaluating Revascularisation Procedures in Peripheral Arterial Disease. [2022]
Short-Term, High-Dose Fish Oil Supplementation Increases the Production of Omega-3 Fatty Acid-Derived Mediators in Patients With Peripheral Artery Disease (the OMEGA-PAD I Trial). [2018]
Self-reported health status and disease-specific quality of life one year after treatment for peripheral arterial disease in clinical practice. [2020]
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