MitoQ for Frail Older Adults

(Mito-Frail Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Oh Sung Kwon, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: UConn Health

Must not be taking: Blood thinners, Corticosteroids

Disqualifiers: Immunodeficiency, Autoimmune disease, Diabetes, others

Prior Safety Data

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.

Trial 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 (Mitochondrial Targeted Antioxidant)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UConn Health Farmington, CT

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Patients Recruited

59,100+

University of Connecticut

Collaborator

Trials

194

Patients Recruited

162,000+

National Institute on Aging (NIA)

Collaborator

Trials

1841

Patients Recruited

28,150,000+

Findings from Research

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]

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]

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]

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]

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]