MitoQ for Frail Older Adults

(Mito-Frail Trial)

Overseen By Oh Sung Kwon, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: UConn Health

Must not be taking: Blood thinners, Corticosteroids

Disqualifiers: Immunodeficiency, Autoimmune disease, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the effects of MitoQ supplementation in older adults and frail older adults with physical dysfunction and/or cognitive dysfunction. The main question\[s\] it aims to answer are: * To compare vascular function, oxidative stress levels, and physical and cognitive function among older adults and frail older adults with physical and cognitive dysfunction * To determine whether MitoQ supplementation has the potential to improve vascular function in central and cerebral vessels * To determine whether MitoQ supplementation can enhance physical and cognitive capabilities.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking blood pressure, blood thinner, or certain immune-altering medications. It's best to discuss your specific medications with the trial team.

How is the drug MitoQ different from other treatments for frail older adults?

MitoQ is unique because it is a mitochondria-targeted antioxidant that may help reduce oxidative stress and support healthy aging by decreasing reactive oxygen species, which are linked to aging and degenerative diseases. Unlike other treatments, MitoQ specifically targets mitochondria, potentially offering anti-immunosenescent benefits by reducing oxidative DNA damage in cells. ^{1 2 3 4 5}

Research Team

Oh Sung Kwon, PhD

Principal Investigator

University of Connecticut

Eligibility Criteria

This trial is for men and women aged 65-80 who are experiencing frailty or mild cognitive issues, specifically those with slow walking speeds or mild memory problems. Participants must be in good heart health without taking any medications that affect blood pressure or metabolism.

Inclusion Criteria

I am between 65-80 years old and either walk slowly or have mild memory problems.

I am not on medication for heart health or blood pressure.

Exclusion Criteria

Baseline ECG QTc >450 ms in men and QTc >460 ms in women

I am taking warfarin or another blood thinner.

I have received a vaccination in the last two weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MitoQ or placebo capsules daily for 12 weeks to assess effects on vascular function, mobility, and cognitive performance

12 weeks

4 visits (in-person)

Washout

Participants undergo an 8-week washout period to eliminate the effects of MitoQ or placebo

8 weeks

No visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MitoQ

Trial Overview The Mito-Frail Trial is testing if a supplement called MitoQ can improve blood vessel function, reduce oxidative stress, and enhance physical movement and thinking skills in older adults who are physically or cognitively frail.

Participant Groups

Group I: MitoQ capsule Experimental Treatment 1 Intervention

Capsules containing mitoquinone mesylate (MitoQ, 5 mg/capsule) totaling 20 mg taken every day for 12 weeks.

Group II: Placebo capsule Placebo Group 1 Intervention

Gelatin capsules

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

University of Connecticut

Collaborator

Trials

194

Recruited

162,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

MitoQ, a targeted antioxidant, effectively reduces oxidative DNA damage in T lymphocytes from older adults when exposed to oxidative stress, indicating its potential to improve immune function with age.

Higher concentrations of mitoQ (0.5 and 1.0 μM) significantly decreased endogenous DNA damage, suggesting that it may help combat age-related decline in immune cell function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation of the effects of MitoQ on human peripheral mononuclear cells. Marthandan, S., Murphy, MP., Billett, E., et al.[2021]

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 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]

In a study involving wild-type C57BL/6 mice treated with the mitochondria-targeted antioxidant mitoquinone mesylate for 15 weeks, the treatment did not prevent the age-related loss of skeletal muscle mass or improve muscle function.

Mitoquinone mesylate administration failed to reduce oxidative damage or alter mitochondrial function, indicating it does not provide protective effects against muscle aging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term administration of the mitochondria-targeted antioxidant mitoquinone mesylate fails to attenuate age-related oxidative damage or rescue the loss of muscle mass and function associated with aging of skeletal muscle. Sakellariou, GK., Pearson, T., Lightfoot, AP., et al.[2022]

In a study involving 21 healthy older adults, a water-soluble CoQ10 syrup formulation showed 2.4 times higher bioavailability compared to standard ubiquinone capsules, indicating it may be a more effective option for supplementation in the elderly.

Despite different formulations, CoQ10 was primarily absorbed in the blood as ubiquinol, suggesting that the form of CoQ10 consumed does not affect its redox status in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Bioavailability of Different Coenzyme Q10 Formulations in Healthy Elderly Individuals. Pravst, I., Rodríguez Aguilera, JC., Cortes Rodriguez, AB., et al.[2020]

References

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

An investigation of the effects of MitoQ on human peripheral mononuclear cells. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Long-term administration of the mitochondria-targeted antioxidant mitoquinone mesylate fails to attenuate age-related oxidative damage or rescue the loss of muscle mass and function associated with aging of skeletal muscle. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Bioavailability of Different Coenzyme Q10 Formulations in Healthy Elderly Individuals. [2020]