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

31 Participants Needed

Trial Summary

What is the purpose of this trial?

In this pilot study, the investigators will determine whether supplementation with a mitochondrial-targeted antioxidant (Mitoquinone (MitoQ)) improves mitochondrial function, left ventricular diastolic and vascular function.

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.

What data supports the effectiveness of the drug Mitoquinone (MitoQ) for cardiovascular health?

Research on Coenzyme Q10 (CoQ10), a component similar to MitoQ, shows it can improve heart function and reduce the need for other heart medications in patients with various heart conditions. CoQ10 has been found to enhance heart health by improving heart muscle function and reducing oxidative stress, which may suggest potential benefits for MitoQ as well. ^{1 2 3 4 5}

Is MitoQ safe for human use?

MitoQ, also known as CoQ10, has been studied in various cardiovascular conditions and is generally considered safe, with few reported side effects such as transient nausea. Long-term studies have shown it to be a safe supplement when used as part of treatment for heart diseases. ^{1 2 6 7 8}

How does the drug MitoQ differ from other treatments for cardiovascular health?

MitoQ is unique because it is a mitochondria-targeted antioxidant, meaning it specifically accumulates in the mitochondria to reduce oxidative stress, which is a key factor in cardiovascular diseases. This targeted approach allows MitoQ to achieve higher concentrations in the mitochondria compared to other antioxidants, potentially making it more effective in reducing oxidative damage and improving heart function. ^{9 10 11 12 13}

Research Team

Shauna Runchey, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Usefulness of coenzyme Q10 in clinical cardiology: a long-term study. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Overview of the use of CoQ10 in cardiovascular disease. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 in the treatment of heart failure: A systematic review of systematic reviews. [2019]

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

Lack of effect of coenzyme Q on left ventricular function in patients with congestive heart failure. [2019]

5. Ukraine pubmed.ncbi.nlm.nih.gov

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

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

Multi-Criteria Decision Analysis Model for Assessing the Risk from Multi-Ingredient Dietary Supplements (MIDS). [2021]

7. England pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. [2021]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Coenzyme q10 in complex therapy of patients with ischemic heart disease]. [2017]

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

Animal and human studies with the mitochondria-targeted antioxidant MitoQ. [2022]

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

Effects of a mitochondrial-targeted ubiquinol on vascular function and exercise capacity in chronic kidney disease: a randomized controlled pilot study. [2023]

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

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

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Mitochondrially targeted antioxidants for the treatment of cardiovascular diseases. [2019]

13. Singapore pubmed.ncbi.nlm.nih.gov

Endurance training and MitoQ supplementation improve spatial memory, VEGF expression, and neurogenic factors in hippocampal tissue of rats. [2023]