MitoQ for Cardiovascular Disease

(MOVHS Trial)

Overseen By Zach J Hutchison, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Disqualifiers: Cardiovascular disease, Cancer, Diabetes, others

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the supplement MitoQ can reduce oxidative stress and improve blood vessel function, particularly in Black adults at higher risk of heart disease. Researchers will compare MitoQ to a placebo (a pill with no active ingredients) over eight weeks to determine its effect on lowering blood pressure and addressing racial differences in heart health. Participants will also provide information about lifestyle factors such as diet and exercise. The trial is suitable for adults aged 45-75 with controlled blood pressure and no history of major diseases like diabetes or heart disease. As an unphased trial, it offers participants the chance to contribute to important research that could lead to better heart health solutions for diverse populations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should be free from certain medical conditions and not have allergies to MitoQ.

Is there any evidence suggesting that MitoQ is likely to be safe for humans?

Research has shown that MitoQ, an antioxidant that works in cells, is generally safe for use. One study found that MitoQ improved artery health, a positive sign for heart health. Another study showed that using MitoQ for six weeks was safe, with no major side effects. Additionally, MitoQ improved heart health markers without causing harm. Overall, these findings suggest that MitoQ is safe for short-term use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MitoQ for cardiovascular disease because it introduces a unique approach to managing the condition. Unlike standard treatments such as beta-blockers, ACE inhibitors, and statins, which primarily focus on controlling symptoms and risk factors, MitoQ targets oxidative stress at the cellular level. This supplement contains a powerful antioxidant designed to specifically penetrate mitochondria, potentially leading to improved heart health by addressing a root cause of cardiovascular damage. This innovative mechanism offers hope for more effective management of cardiovascular disease with potentially fewer side effects.

What evidence suggests that MitoQ might be an effective treatment for cardiovascular disease?

Research has shown that MitoQ might support heart and blood vessel health. Studies have found that MitoQ can enhance heart function by reducing heart muscle thickening. Early evidence also suggests that MitoQ improves blood vessel function and reduces arterial stiffness, which can help maintain healthy blood pressure. Additionally, reports indicate that MitoQ protects against blood vessel problems, especially in conditions like high blood pressure and diabetes. These findings suggest that MitoQ may help manage heart health risks, particularly in those more affected by these conditions. Participants in this trial will receive either MitoQ supplementation or a placebo to further evaluate these potential benefits. ^{1 3 6 7 8}

Who Is on the Research Team?

Austin T Robinson, PhD

Principal Investigator

Kinesiology Building

Are You a Good Fit for This Trial?

This trial is for middle-aged and older adults (45-75 years old) who are generally healthy but at risk of cardiovascular disease, particularly Black Americans. Participants must not have medical conditions that prevent exercise, giving blood, or allergies to MitoQ ingredients. They should have a BMI under 40 Kg/m2 and blood pressure below 150/90 mmHg without a history of serious diseases like cancer, diabetes, or heart issues.

Inclusion Criteria

Have blood pressure no higher than 150/90 mmHg

I am between 45 and 75 years old.

I don't have health problems that stop me from exercising, giving blood, or taking MitoQ.

Exclusion Criteria

Known allergy to MitoQ

I have a history of kidney disease.

My BMI is over 40.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including blood draws, vascular testing, and questionnaires on sleep, mood, and social determinants of health

2 weeks

1-2 visits (in-person)

Treatment

Participants receive 8-week supplementation of MitoQ or placebo, with blood pressure and vascular function assessments

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-treatment blood draws and vascular testing

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MitoQ

Trial Overview The study tests if the antioxidant MitoQ can reduce oxidative stress and improve vascular health over an 8-week period in individuals at risk for cardiovascular disease. It involves daily consumption of MitoQ compared to a placebo while also considering social factors and health behaviors.

How Is the Trial Designed?

Group I: MitoQ Experimental Treatment 1 Intervention

8-week MitoQ supplementation (20 mg daily capsule).

Group II: Placebo Placebo Group 1 Intervention

8-week placebo matched in appearance to MitoQ supplementation (20 mg daily capsule).

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Published Research Related to This Trial

CoQ10 supplementation has shown promise in improving various cardiovascular conditions, including congestive heart failure and ischemic heart disease, based on a review of 34 controlled trials and additional long-term studies.

Achieving higher blood levels of CoQ10 (over 3.5 micrograms/ml) through increased dosages is associated with greater clinical improvements, suggesting that CoQ10 may play a significant role in cardiovascular health and disease prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the use of CoQ10 in cardiovascular disease. Langsjoen, PH., Langsjoen, AM.[2019]

Coenzyme Q10 (CoQ10) supplementation has been shown to reduce mortality and improve exercise capacity in patients with heart failure, highlighting its potential as an effective treatment for cardiovascular diseases.

CoQ10 can also lower blood pressure in hypertensive patients and protect heart function during chemotherapy, suggesting it may have multiple beneficial effects in cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of coenzyme Q10 in supportive therapy of the cardiovascular diseases and in the prevention of cardiotoxicity caused by chemotherapy. Miedziaszczyk, M., Cieślewicz, A., Jabłecka, A.[2022]

Co-enzyme Q10 is a naturally occurring substance that may help prevent cellular damage during heart-related issues like myocardial ischemia and reperfusion, suggesting its potential protective role in cardiovascular health.

It has been used orally to treat various cardiovascular disorders, including angina, hypertension, and congestive heart failure, and its clinical significance is being validated through ongoing clinical trials globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-enzyme Q10: a new drug for cardiovascular disease. Greenberg, S., Frishman, WH.[2019]

Coenzyme Q10 (CoQ10) supplementation may help improve health outcomes in patients with cardiovascular diseases by reducing inflammatory and oxidative stress markers, as shown in several randomized clinical trials.

Despite promising results, further research with larger patient groups is needed to confirm the efficacy of CoQ10 as a therapeutic approach for conditions like heart failure and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coenzyme Q10: Clinical Applications in Cardiovascular Diseases. Martelli, A., Testai, L., Colletti, A., et al.[2020]

In a study of 424 patients with various cardiovascular diseases over eight years, coenzyme Q10 (CoQ10) was found to be a safe and effective adjunct treatment, with 58% of patients showing improvement in their heart function by at least one class on the New York Heart Association scale.

CoQ10 treatment led to a significant reduction in the need for other cardiac medications, with 43% of patients stopping one to three drugs, indicating its potential to simplify treatment regimens without notable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of coenzyme Q10 in clinical cardiology: a long-term study. Langsjoen, H., Langsjoen, P., Langsjoen, P., et al.[2019]

Coenzyme Q10 (ubiquinone) is essential for ATP synthesis in mitochondria and acts as an antioxidant, with deficiencies linked to various cardiovascular diseases such as heart failure and coronary artery disease.

Clinical trials suggest that Q10 supplementation can provide significant benefits in the prevention and treatment of cardiovascular conditions, making it a recommended adjunct therapy alongside standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Physiological aspects of ubiquinone supplementation in cardiovascular pathology]. Kuchmenko, OB.[2006]

CoQ10 supplementation may be beneficial as an adjunctive therapy for patients with congestive heart failure, particularly for those who cannot tolerate standard medical treatments, based on evidence from seven systematic reviews.

The reviews indicated improvements in key cardiovascular measures such as cardiac output and functional classification, suggesting that CoQ10 could play a role in managing cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 in the treatment of heart failure: A systematic review of systematic reviews. Jafari, M., Mousavi, SM., Asgharzadeh, A., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11934253

Overview of MitoQ on prevention and management of ... The studies reviewed in this scoping analysis collectively highlighted the effect of MitoQ on prevention and management of CMD and underlying ...

2. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.109.130351

Mitochondria-Targeted Antioxidant MitoQ 10 Improves ... Cardiac hypertrophy was significantly reduced by MitoQ10 treatment compared with untreated control and decylTPP treatment (MitoQ10: 4.01±0.05 mg/g; control: ...

3. heart.bmj.com heart.bmj.com/content/111/Suppl_3/A284

C Therapeutic potential of the mitochondrial antioxidant ... Four months of mitoquinone administration led to a significant improvement in rest PCr/ATP (1.58[1.41,1.74] to 1.78[1.65,1.91];P=0.028), and stress PCr/ATP ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9520456/

Mitochondrial-targeted antioxidant supplementation for ... We obtained initial evidence of efficacy of MitoQ for improving endothelial function and reducing arterial stiffness in a pilot clinical trial in older ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772976125001886

MitoQ Protects Against Oxidative Stress-Induced ... Mitoquinone mesylate (MitoQ), a mitochondrial-targeted antioxidant has been reported to be protective against vascular dysfunction in hypertension, diabetic ...

6. mitoq.com mitoq.com/pages/research?srsltid=AfmBOopI9LyHhwU2E_J80gHinkJCDZ7RJobm4R5NXwm4j-xIBmL0tMgA

mitoquinol mesylate research studies & clinical trials In this clinical trial it was confirmed that: MitoQ greatly improved the ability of arteries to dilate (by 42%). MitoQ significantly supports the health of ...

7. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.117.10787

Chronic Supplementation With a Mitochondrial Antioxidant ... We show that chronic administration of MitoQ increased plasma MitoQ levels and was safe and well tolerated over the treatment duration (6 weeks) ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667137922000091

Pharmacological significance of MitoQ in ameliorating ... They demonstrated that MitoQ improved fine motor function and learning impairment caused by rmTBI, possibly by reducing astrocytosis, microgliosis, dendritic ...