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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if MitoQ, a supplement, can improve physical and mental abilities in older adults with mobility or cognitive challenges. Researchers seek to understand if MitoQ can enhance blood vessel function and reduce oxidative stress, factors linked to aging and health issues. Suitable participants are men and women aged 65-80 who walk slowly or have mild cognitive issues but are otherwise in good heart health. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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.

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

Research has shown that MitoQ, a supplement, offers potential benefits based on earlier studies. These studies examined its effects on older adults, focusing on blood vessel health and damage from free radicals. Importantly, they found that MitoQ is generally safe for participants.

Some mild side effects have been reported, which is common in supplement trials. Although no major safety issues have emerged, it is important to note that this trial remains in an early stage. Researchers continue to explore the safety and effectiveness of MitoQ for frail older adults.

If MitoQ proves as safe as earlier studies suggest, it could enhance physical and mental health in older adults. Always consult a healthcare provider before joining any trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for frailty in older adults, which often focus on exercise and nutritional support, MitoQ offers a novel approach by targeting cellular health directly. MitoQ is a form of the antioxidant Coenzyme Q10, but it's designed to penetrate the mitochondria more effectively, potentially reducing oxidative stress at the cellular level. This unique mechanism of action could improve energy production and reduce frailty symptoms more efficiently than current options, sparking excitement among researchers.

What evidence suggests that MitoQ might be an effective treatment for frail older adults?

Research shows that MitoQ, a supplement aimed at improving the health of cellular powerhouses, may aid older adults with physical and mental functions. In this trial, some participants will receive MitoQ capsules, while others will receive a placebo. Studies have found that MitoQ can improve blood flow, which is important because better blood flow can lead to easier movement and clearer thinking. Participants who have taken MitoQ reported less oxidative stress, often linked to aging and weakness. While more research is needed, early results are promising for MitoQ's potential benefits for older adults facing physical and mental challenges. ^{1 2 6 7 8}

Who Is on the Research Team?

Oh Sung Kwon, PhD

Principal Investigator

University of Connecticut

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11035191

The Mito-Frail Trial We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06027554/the-mito-frail-trial-effects-of-mitoq-on-vasodilation-mobility-and-cognitive-performance-in-frail-older-adults

The Mito-Frail Trial: Effects of MitoQ on Vasodilation ... The goal of this clinical trial is to test the effects of MitoQ supplementation in older adults and frail older adults with physical dysfunction ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/436319

The Mito-Frail Trial: Effects of MitoQ on Vasodilation, ... The goal of this clinical trial is to test the effects of MitoQ supplementation in older adults and frail older adults with physical ...

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

NCT02597023 | The Efficacy of Oral Mitoquinone (MitoQ) ... The purpose of this study is to assess the efficacy of supplementation with the mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/436319

The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility ... 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 ...

6. withpower.com withpower.com/trial/phase-2-frailty-8-2023-060e2

MitoQ for Frail Older Adults (Mito-Frail Trial) The Mito-Frail medical study, being run by UConn Health, is evaluating whether MitoQ will have tolerable side effects & efficacy for patients with Frailty, ...

7. reporter.nih.gov reporter.nih.gov/search/Rs4bfwRRMU2v7R6jgzS4SA/project-details/11035191

The Mito-Frail Trial - NIH RePORTER In the Mito-Frail study we now wish to explore the hypothesis that MitoQ attenuates aging- related declines in flow-mediated vasodilation involving both ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02597023

NCT02597023 | The Efficacy of Oral Mitoquinone (MitoQ) ... The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults. Conditions. Aging. Aging. Aging. Aging.