Antioxidant Supplementation for Aging-Related Vascular Dysfunction

Overseen By Matthew J Rossman, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Boulder

Disqualifiers: Uncontrolled thyroid disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 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 improve blood vessel health in older adults. It aims to reduce oxidative stress (damage caused by free radicals) in the blood vessels, potentially lowering the risk of heart-related issues. Participants will take either MitoQ or a placebo for three months to assess improvements in blood vessel function and stiffness. Individuals aged 60 or older, with stable weight, and who do not engage in vigorous exercise might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

A previous study found MitoQ to be safe and well-tolerated in older adults, with participants experiencing no serious side effects. Research has shown that MitoQ improves blood vessel function by targeting mitochondria, the energy centers in cells. This is crucial because, with age, mitochondria can produce harmful substances called reactive oxygen species (ROS), potentially leading to heart problems. In a small pilot study, older adults taking MitoQ demonstrated better heart and artery health without major negative effects. These findings suggest that MitoQ is a promising and safe option for enhancing blood vessel health in older adults. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike other treatments for aging-related vascular dysfunction, which often focus on managing symptoms or improving lifestyle, MitoQ targets the root cause at a cellular level. MitoQ is a powerful antioxidant that directly targets mitochondria, the energy factories of our cells, to reduce oxidative stress, a key factor in vascular aging. Researchers are excited about MitoQ because it offers a novel approach by not just alleviating symptoms but potentially slowing down or reversing cellular aging processes, paving the way for improved vascular health in the elderly.

What evidence suggests that MitoQ might be an effective treatment for aging-related vascular dysfunction?

Research has shown that MitoQ, a special antioxidant targeting the energy centers of cells, holds promise for improving blood vessel health in older adults. In studies with older mice, MitoQ fully restored blood vessel function and reduced stiffness in major arteries. A small study involving 20 older adults found that MitoQ improved blood vessel health and reduced damage from free radicals, harmful molecules. Participants also experienced less stiff arteries, a common issue with aging. In this trial, participants will receive either MitoQ or a placebo to evaluate its potential to lower the risk of heart and blood vessel problems related to aging by reducing harmful stress in cells. ^{1 2 4 6 7}

Who Is on the Research Team?

Douglas R Seals, PhD

Principal Investigator

University of Colorado, Boulder

Are You a Good Fit for This Trial?

This trial is for men and women aged 60 or older who are mentally fit (with a mini-mental exam score of at least 21), not alcohol dependent, have had stable weight recently, and aren't heavily involved in vigorous aerobic activities. Those with uncontrolled thyroid disease or recent blood donations are excluded.

Inclusion Criteria

Willing to accept random assignment to condition

Body mass index <40 kg/m2

Ability to provide informed consent

Exclusion Criteria

Blood donation within 8 weeks prior to enrolling in the study

My thyroid condition is not under control.

Regular vigorous aerobic (>6 bouts/week, >60 min/bout at a workload >6 METS)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral MitoQ (20 mg/day) or placebo for 3 months to improve endothelial function and assess effects on aortic stiffness

12 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MitoQ
• Placebo

Trial Overview The study tests if MitoQ, an antioxidant targeting mitochondria, can improve vascular function by reducing oxidative stress in the elderly when taken orally for three months compared to a placebo. The effects on endothelial function and aortic stiffness will be measured.

How Is the Trial Designed?

Group I: MitoQ, 20 mg/day Experimental Treatment 1 Intervention

Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 3 months.

Group II: Placebo Placebo Group 1 Intervention

Matched placebo capsules.

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

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]

Vascular dysfunction, which includes issues like endothelial dysfunction and stiffening of arteries, is a significant risk factor for cardiovascular disease (CVD), making it a key target for prevention and management strategies.

Mitochondrial function plays a crucial role in maintaining vascular health, and impairments in this function can lead to increased CVD risk; both lifestyle changes and pharmaceutical interventions targeting mitochondrial health may help improve vascular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitochondrial contributions to vascular endothelial dysfunction, arterial stiffness, and cardiovascular diseases. Kirkman, DL., Robinson, AT., Rossman, MJ., et al.[2022]

Acute high-dose MitoQ supplementation (100-160 mg) in 32 healthy adults showed no significant changes in urinary biomarkers associated with kidney injury, suggesting it is not nephrotoxic.

The study's results support the safety of MitoQ for further research on its effects related to mitochondrial oxidative stress, as it did not affect kidney function or injury markers in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute High Dose MitoQ Does not Increase Urinary Kidney Injury Markers in Healthy Adults. Linder, BA., Stute, NL., Hutchison, ZJ., et al.[2023]

An oral antioxidant cocktail consisting of vitamins C, E, and alpha-lipoic acid significantly reduced circulating free radicals by approximately 98% at rest and 85% during exercise in a study of 25 healthy young males.

Despite the reduction in free radicals, the antioxidant cocktail led to decreased vasodilation during exercise compared to a placebo, suggesting that free radicals may play a beneficial role in normal vascular function during physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-induced brachial artery vasodilation: role of free radicals. Richardson, RS., Donato, AJ., Uberoi, A., et al.[2020]

In a study involving 1162 healthy participants over an average of 7.2 years, daily low-dose antioxidant supplementation was associated with a higher percentage of carotid plaques compared to a placebo group (35.2% vs. 29.5%).

The study found no significant benefits of antioxidant supplementation on common carotid intima-media thickness or arterial stiffness, suggesting that long-term use may not improve vascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of long-term daily low-dose supplementation with antioxidant vitamins and minerals on structure and function of large arteries. Zureik, M., Galan, P., Bertrais, S., et al.[2016]

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 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]

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 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]

Aging leads to significant molecular and cellular changes in blood vessels, which are linked to increased oxidative stress and inflammation, contributing to vascular diseases in elderly patients.

Practical interventions such as anti-inflammatory treatments, regular exercise, dietary changes, and caloric restriction mimetics may help prevent or improve age-related vascular dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of vascular aging: new perspectives. Ungvari, Z., Kaley, G., de Cabo, R., et al.[2022]

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. 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 ...

3. mitoq.com mitoq.com/pages/research?srsltid=AfmBOooiJRzNKCB_cBJ1w_YOw3T9CzksmH1LBT-_iXDonoywqfNAgMCq

mitoquinol mesylate research studies & clinical trials MitoQ decreases free radical production by mitochondria, and significantly supports arterial function in older adults and therefore the health of the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02597023

NCT02597023 | The Efficacy of Oral Mitoquinone (MitoQ) ... Chronic Supplementation With a Mitochondrial Antioxidant (MitoQ) Improves Vascular Function in Healthy Older Adults. Hypertension. 2018 Jun;71(6):1056-1063 ...

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

Pharmacological significance of MitoQ in ameliorating ... In another similar study, Rossman et al. conducted a human trial to assess the effect of MitoQ on age-related vascular dysfunction. The study involved 20 ...

6. mitoq.com mitoq.com/pages/research?srsltid=AfmBOopekrBnBa8mSoFe24ND1kbipVApZF_zE3Uhing_qwjqgg8nK9xY

mitoquinol mesylate research studies & clinical trials MitoQ decreases free radical production by mitochondria, and significantly supports arterial function in older adults and therefore the health of the ...

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

Overview of MitoQ on prevention and management ... The data extraction process was particularly focused on outcomes pertinent to metabolic health (mitochondrial function, oxidative stress ...