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

Trial Summary

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.

What data supports the effectiveness of the drug MitoQ for blood vessel health?

Research shows that MitoQ, a mitochondrial-targeted antioxidant, improves blood vessel function in older adults by reducing oxidative stress and improving the flexibility of arteries. In studies, MitoQ increased blood flow and reduced arterial stiffness, suggesting it may help with age-related blood vessel issues. ^{1 2 3 4 5}

Is MitoQ safe for human use?

MitoQ, a mitochondria-targeted antioxidant, has been tested in clinical trials with healthy older adults and was well tolerated, showing no significant safety concerns. It has been used in studies to improve vascular function and reduce oxidative stress, suggesting it is generally safe for human use. ^{1 3 4 6 7}

How is the drug MitoQ different from other treatments for blood vessel health?

MitoQ is unique because it specifically targets mitochondria (the energy-producing parts of cells) to reduce oxidative stress, which is a key factor in age-related blood vessel problems. Unlike other antioxidants, MitoQ is designed to improve blood vessel function by directly reducing harmful substances in the mitochondria, potentially offering a more effective approach for older adults. ^{1 2 6 8 9}

What is the purpose of this trial?

Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide, and the non-Hispanic Black (NHB) population is disproportionately affected. Our research has previously demonstrated that oxidative stress may contribute to reduced vascular function in otherwise healthy NHB adults, potentially predisposing them to the development of hypertension and CVD. This study is designed to examine whether the mitochondria are an important source of oxidative stress-induced vascular dysfunction in healthy NHB adults.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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(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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Mitochondrial-targeted antioxidant supplementation for improving age-related vascular dysfunction in humans: A study protocol. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Mitochondrial targeted coenzyme Q, superoxide, and fuel selectivity in endothelial cells. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Chronic Supplementation With a Mitochondrial Antioxidant (MitoQ) Improves Vascular Function in Healthy Older Adults. [2022]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Effect of MitoQ on Aging-Related Biomarkers: A Systematic Review and Meta-Analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Quantitation and metabolism of mitoquinone, a mitochondria-targeted antioxidant, in rat by liquid chromatography/tandem mass spectrometry. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Mitochondria-targeted antioxidant MitoQ10 improves endothelial function and attenuates cardiac hypertrophy. [2021]

8. Netherlands 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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