MitoQ Supplementation for Cardiovascular Health

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Antioxidants, Corticosteroids, Anti-inflammatories, others

Disqualifiers: Cancer, Cardiovascular disease, Menses, others

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

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 a supplement called MitoQ can enhance heart and blood vessel health by improving mitochondrial function. Participants will take either MitoQ or a placebo (a harmless pill with no active ingredients) and then switch after a break. The trial suits healthy non-smokers who exercise vigorously no more than two days a week and are not taking certain medications or supplements. Those with a history of cancer or heart disease should not participate. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially improve heart health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, including antioxidant vitamins, corticosteroids, anti-inflammatory medications, sex hormone therapy, and any other medications that might interact with MitoQ or affect cardiovascular function.

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

Research has shown that MitoQ is generally safe for use. Studies have found it can be taken safely for up to one year, even at doses as high as 80 mg per day. Participants in these studies handled MitoQ well, with no major side effects reported. This is reassuring, especially since the current trial uses a lower dose of 20 mg. Overall, evidence suggests that most people tolerate MitoQ well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mitoquinone (MitoQ) because it offers a unique approach to supporting cardiovascular health by directly targeting and reducing oxidative stress in mitochondria. Unlike traditional treatments that primarily focus on controlling symptoms or managing risk factors like high blood pressure or cholesterol, MitoQ works at a cellular level, potentially preventing damage before it occurs. This targeted antioxidant action could lead to improved heart health outcomes, making it a promising option for individuals seeking novel ways to support their cardiovascular system.

What evidence suggests that Mitoquinone (MitoQ) might be an effective treatment for cardiovascular health?

Research has shown that MitoQ, a special antioxidant targeting the mitochondria, can greatly improve heart and artery health. One study found that MitoQ increased the ability of arteries to widen by 42%, which is important for good blood flow. Another study demonstrated that MitoQ helps protect blood vessels in people with high blood pressure and diabetes. Additionally, when combined with moderate exercise, MitoQ improved heart function and lowered blood pressure. This trial will evaluate MitoQ's effectiveness in improving heart and blood vessel health, with participants receiving either MitoQ followed by a placebo or a placebo followed by MitoQ. ^{2 3 6 7 8}

Who Is on the Research Team?

Shauna Runchey, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 50-75 who are not very active, don't smoke, and aren't taking antioxidants, steroids or anti-inflammatory meds. They shouldn't have had cancer, cardiovascular disease or be on hormone therapy.

Inclusion Criteria

sedentary-to-recreationally active (<3 days of vigorous exercise)

healthy, as determined by medical history, physical examination, standard blood chemistries

I am between 50 and 75 years old.

Exclusion Criteria

I have had cancer in the past.

I have a history of heart disease.

I am willing and able to take MitoQ supplement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mitoquinol Mesylate or placebo for 4 weeks, followed by a washout period, then crossover to the alternate treatment for another 4 weeks

8 weeks

4 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

• Mitoquinone (MitoQ)

Trial Overview The study tests if MitoQ (a targeted antioxidant) can improve heart's mitochondrial function and blood vessel health in participants. They'll take MitoQ first then a placebo, or vice versa to compare effects.

How Is the Trial Designed?

Group I: B: Placebo then 'MITOQUINOL MESYLATE' Experimental Treatment 1 Intervention

Placebo capsule administered twice daily for 4 weeks followed by a washout period, then 'MITOQUINOL MESYLATE' administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'

Group II: A: 'MITOQUINOL MESYLATE then placebo Experimental Treatment 1 Intervention

'MITOQUINOL MESYLATE' administered twice daily for 4 weeks followed by a washout, then placebo capsule administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

University of Colorado Nutrition Obesity Research Center (NORC)

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

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]

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]

A study analyzing 110 reports of adverse reactions to herbal dietary supplements in Italy found that 23 serious reactions occurred, with 21 requiring hospitalization, highlighting significant safety concerns regarding these products.

Dermatological and cardiovascular issues were the most common reactions, and 9 out of 10 serious hepatic reactions were reported, indicating that the quality and supervision of these supplements are critical for consumer safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. Ippoliti, I., Menniti-Ippolito, F., Mazzanti, G., et al.[2021]

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]

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]

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]

Citations

1. mitoq.com mitoq.com/pages/research?srsltid=AfmBOooBGryjWxFyvFoEhXFBUsRNXgfuYAqCKUXjCaeTPVDzpVakbwTx

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 ...

2. 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 ...

3. 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 ...

4. mitoq.com mitoq.com/blogs/journal/heart-health-and-how-mitoq-helps?srsltid=AfmBOoq35gxu02pkN_GWP751PnRn7HmDY8QBAqAJgQgTbjrRkqA8W1gZ

Heart health and how MitoQ helps In fact, a recent clinical trial concluded that the MitoQ molecule supports arterial health by greatly improving arterial dilation by 42%.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9617024/

Moderate Endurance Training and MitoQ Improve ... The main results of the present study were that the combination of MitoQ and ET significantly decreased SBP and improved cardiac function indices, including LV ...

6. mitoq.com mitoq.com/blogs/journal/is-mitoq-safe?srsltid=AfmBOopg_x2xVm58sAsYxepId9mW7huHRxOvUz6JkA9xksC84gA-BezY

Is MitoQ safe? Research, certifications and ingredients While MitoQ's recommended daily dose is 10mg per day, clinical trials and studies have shown MitoQ to be safe well beyond the recommended dose.

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

C Therapeutic potential of the mitochondrial antioxidant ... MitoQ administration was also associated with a significant increase in PEDSR, a marker of diastolic function, and was well tolerated by all participants with ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05886816

NCT05886816 | Mitoquinone/mitoquinol Mesylate As Oral ... The secondary objective is to determine the safety of mito-MES for 14 days as post-exposure prophylaxis against SARS-CoV-2 in healthy adults. Official Title.