Antioxidant Supplement for Blood Vessel Health

Overseen By Melissa Gorejena

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: S. Tony Wolf

Must not be taking: Steroids, Barbiturates, Anticonvulsants, others

Disqualifiers: Skin disorders, Smoking, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether MitoQ, an antioxidant supplement, can improve blood vessel health by reducing oxidative stress in healthy non-Hispanic Black adults. Oxidative stress may damage blood vessels, potentially leading to heart issues like hypertension. Participants will receive both MitoQ and a placebo in different sequences to compare their effects. Ideal candidates are healthy non-Hispanic Black individuals without high blood pressure or diabetes and not taking medications that affect heart health. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important health discoveries.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants who are taking medications that could affect cardiovascular responses or specific drugs like chloramphenicol, cholestyramine, and others listed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MitoQ, the treatment being tested, has generally been well-tolerated. In one study, participants taking MitoQ did not report significant side effects compared to those on a placebo. Another study found that MitoQ was safe when taken daily in smaller doses for a few weeks. These results suggest that MitoQ may be safe for short-term use. However, individual reactions can differ with any treatment. Discussing potential risks with a healthcare provider before joining a clinical trial is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cardiovascular disease?

MitoQ is unique because it targets the mitochondria, the energy powerhouses of cells, to deliver antioxidants directly where they are needed most. Unlike traditional antioxidant supplements that work more generally in the body, MitoQ's targeted action could mean more effective protection of blood vessels from oxidative stress. Researchers are excited about MitoQ because it has the potential to improve blood vessel health more efficiently than existing treatments, which typically focus on broad antioxidant effects.

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

Research has shown that MitoQ, a special antioxidant targeting the mitochondria, can greatly improve blood vessel health. One study found that MitoQ increased the ability of arteries to widen by 42%, indicating better blood flow and lower blood pressure. Other studies have demonstrated that MitoQ helps reduce oxidative stress, which is damage caused by harmful molecules in the body linked to heart problems. In animal studies, MitoQ protected against high blood pressure and improved heart and blood vessel function. Early findings also suggest that MitoQ can support heart health and lower the risk of heart disease. This trial will evaluate MitoQ's effects on blood vessel health, with participants receiving either MitoQ followed by a placebo or a placebo followed by MitoQ. MitoQ appears to be a promising option for improving blood vessel health in people. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy non-Hispanic Black or White adults, aged 18-60, with normal blood pressure and cholesterol levels. Participants should not have diabetes (HbA1C <6.0%). It's designed to study blood vessel health in those who are not currently diagnosed with hypertension or cardiovascular disease.

Inclusion Criteria

I identify as either non-Hispanic Black or non-Hispanic White.

My LDL cholesterol is below 150mg/dl.

My blood pressure is below 130/85 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of 80mg MitoQ or placebo, followed by a crossover to the other treatment after a minimum of 14 days

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MitoQ

Trial Overview The study tests if antioxidants like MitoTempo, Tempol, MitoQ can improve vascular function by reducing oxidative stress. Some participants will receive a placebo instead of the active supplements. The effects on blood vessels will be compared across different groups.

How Is the Trial Designed?

Group I: Placebo, then MitoQ Experimental Treatment 6 Interventions

Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days

Group II: MitoQ, then Placebo Experimental Treatment 6 Interventions

Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days

Who Is Running the Clinical Trial?

S. Tony Wolf

Lead Sponsor

Trials

1

Recruited

60+

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

Published Research Related to This Trial

In a study involving 20 healthy older adults, 6 weeks of oral supplementation with the mitochondrial-targeted antioxidant MitoQ significantly improved endothelial function, as indicated by a 42% increase in brachial artery flow-mediated dilation compared to placebo.

MitoQ was well tolerated and also reduced aortic stiffness and plasma oxidized LDL levels, suggesting its potential as a therapeutic strategy for age-related vascular dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Supplementation With a Mitochondrial Antioxidant (MitoQ) Improves Vascular Function in Healthy Older Adults. Rossman, MJ., Santos-Parker, JR., Steward, CAC., et al.[2022]

A study involving 20 healthy young nonsmoking subjects showed that acute supplementation with CoQ10 phytosome significantly improved endothelial reactivity compared to baseline and placebo, indicating its potential cardiovascular benefits.

Chronic supplementation with CoQ10 phytosome also led to significant improvements in mean arterial pressure and total antioxidant capacity, suggesting enhanced vascular health and antioxidant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive instrumental evaluation of coenzyme Q10 phytosome on endothelial reactivity in healthy nonsmoking young volunteers: A double-blind, randomized, placebo-controlled crossover clinical trial. Cicero, AFG., Fogacci, F., Di Micoli, A., et al.[2022]

MitoQ, a mitochondria-targeted antioxidant, significantly reduced nitrotyrosine concentration, indicating its potential to alleviate oxidative stress associated with aging, based on a meta-analysis of 27 studies involving 190 animals.

The intervention also improved mitochondrial membrane potential, suggesting that MitoQ may support healthier mitochondrial function as we age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of MitoQ on Aging-Related Biomarkers: A Systematic Review and Meta-Analysis. Braakhuis, AJ., Nagulan, R., Somerville, V.[2023]

Chronic supplementation with the mitochondria-targeted antioxidant MitoQ significantly improves endothelial function in older adults by enhancing nitric oxide production and reducing mitochondrial oxidative stress, as shown in a clinical trial with 19 participants.

MitoQ treatment leads to lower levels of oxidized low-density lipoprotein (oxLDL) in the plasma, which is crucial for the observed improvements in endothelial function, indicating that changes in the circulating environment play a key role in its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic mitochondria antioxidant treatment in older adults alters the circulating milieu to improve endothelial cell function and mitochondrial oxidative stress. Murray, KO., Ludwig, KR., Darvish, S., et al.[2023]

In a study involving 10 older men, supplementation with ubiquinol significantly increased plasma levels of CoQ10, suggesting it is more effective than ubiquinone for enhancing CoQ10 status.

Neither ubiquinol nor ubiquinone supplementation affected biomarkers of oxidative stress, indicating that while ubiquinol improves CoQ10 levels, it does not influence oxidative stress markers in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ubiquinol is superior to ubiquinone to enhance Coenzyme Q10 status in older men. [2019]

The ongoing phase IIa clinical trial is investigating the efficacy of MitoQ, a mitochondrial-targeted antioxidant, in improving vascular function in 90 healthy older adults aged 60 and above, with a focus on nitric oxide-mediated dilation as the primary outcome.

Initial evidence from a previous pilot study suggested that MitoQ may enhance vascular function by reducing mitochondrial reactive oxygen species, which are linked to age-related vascular dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitochondrial-targeted antioxidant supplementation for improving age-related vascular dysfunction in humans: A study protocol. Murray, KO., Berryman-Maciel, M., Darvish, S., et al.[2022]

A sensitive and accurate liquid chromatography/tandem mass spectrometry (LC/MS/MS) assay was developed to measure mitoquinone levels and its metabolites in rat plasma, demonstrating a linear calibration curve and a low limit of quantitation (0.5 ng/mL).

The pharmacokinetic study identified four metabolites of MitoQ10 in rat plasma, suggesting that MitoQ10 is effectively processed in the body, which is important for understanding its potential therapeutic effects in neurodegenerative diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitation and metabolism of mitoquinone, a mitochondria-targeted antioxidant, in rat by liquid chromatography/tandem mass spectrometry. Li, Y., Zhang, H., Fawcett, JP., et al.[2018]

MitoQ, a mitochondrial-targeted antioxidant, was found to increase respiration in cells using complex I substrates and enhance glucose oxidation while reducing fat oxidation, indicating its role in altering fuel selectivity in intact cells.

The study demonstrated that MitoQ interacts with complex I in a way that increases reactive oxygen species (ROS) production, suggesting that its effects are more complex than previously thought and depend on the type of substrate used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitochondrial targeted coenzyme Q, superoxide, and fuel selectivity in endothelial cells. Fink, BD., O'Malley, Y., Dake, BL., et al.[2021]

MitoQ(10), a mitochondria-targeted antioxidant, significantly reduced systolic blood pressure by approximately 25 mm Hg and improved endothelial function in stroke-prone spontaneously hypertensive rats over an 8-week treatment period.

MitoQ(10) also decreased cardiac hypertrophy compared to untreated controls and another compound, suggesting its potential as a novel therapeutic intervention for preventing hypertension and related cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitochondria-targeted antioxidant MitoQ10 improves endothelial function and attenuates cardiac hypertrophy. Graham, D., Huynh, NN., Hamilton, CA., et al.[2021]

Citations

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

Mitochondrial-targeted antioxidant supplementation for ... This study is designed to establish the efficacy of chronic supplementation with the mitochondrial-targeted antioxidant MitoQ for improving vascular ...

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

Mitochondria-Targeted Antioxidant MitoQ 10 Improves ... MitoQ 10 protects against the development of hypertension, improves endothelial function, and reduces cardiac hypertrophy in young stroke-prone spontaneously ...

3. mitoq.com mitoq.com/pages/research?srsltid=AfmBOooGutnt7i8oNjLWr9yI_cD5LmTNWXS5djieqacYXbIKV5Dfpr3O

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5945293/

Chronic supplementation with a mitochondrial antioxidant ... MitoQ supplementation improved vascular endothelial function in healthy late middle-aged and older adults by reducing the tonic suppressive effects of excessive ...

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1506460/full

Overview of MitoQ on prevention and management ... in vivo studies showed that MitoQ had demonstrated multiple positive effects on cardiovascular health (33, 34), anti-oxidative stress (34, 35) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05886816

Mitoquinone/mitoquinol Mesylate As Oral and Safe ... The overall goal of the study is to determine the efficacy of the treatment with mito-MES 20 mg daily versus placebo for 14 days to prevent confirmed SARS-CoV- ...

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

Chronic Supplementation With a Mitochondrial Antioxidant ... MitoQ was well tolerated, and plasma MitoQ was higher after the treatment versus placebo period (P<0.05). Brachial artery flow–mediated dilation ...

8. mitoq.com mitoq.com/blogs/journal/how-does-mitoq-work-the-mitoq-mechanism-of-action?srsltid=AfmBOoqbvG-UXwcmc7dJFgJbpp5xtU0WvxrBO-NGGJacHLfXV9uUkqd0

How does MitoQ work – the mechanism of action By rejuvenating cell health, MitoQ has been shown to help improve sport and exercise performance, cardiovascular health, and promote healthier ageing. ... and ...