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Antioxidant

Antioxidant Supplementation for Aging-Related Vascular Dysfunction

Phase 2
Recruiting
Led By Douglas R Seals
Research Sponsored by University of Colorado, Boulder
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 60 years and over
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will study the effects of MitoQ, a mitochondria-targeted antioxidant, on vascular function in older adults.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, previous studies suggest that MitoQ was well-tolerated by older adults. However, as with any supplement, potential side effects may include digestive discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 60 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in endothelial function at 3 months
Secondary outcome measures
Change from baseline in aortic stiffness at 3 months
Change from baseline in suppression of endothelial function by mitochondrial oxidative stress at 3 months
Other outcome measures
Change from baseline in carotid artery stiffness at 3 months
Change from baseline in cerebrovascular reactivity at 3 months
Change from baseline in circulating marker of oxidative stress at 3 months
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MitoQ, 20 mg/dayExperimental Treatment1 Intervention
Each MitoQ capsule contains 20 mg of mitoquinol mesylate. Dosage: 20 mg orally per day for 3 months.
Group II: PlaceboPlacebo Group1 Intervention
Matched placebo capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MitoQ
2006
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

University of Colorado, BoulderLead Sponsor
119 Previous Clinical Trials
29,082 Total Patients Enrolled
10 Trials studying Aging
952 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,793 Total Patients Enrolled
160 Trials studying Aging
75,895 Patients Enrolled for Aging
Douglas R SealsPrincipal InvestigatorUniversity of Colorado, Boulder

Media Library

MitoQ (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT04851288 — Phase 2
Aging Research Study Groups: MitoQ, 20 mg/day, Placebo
Aging Clinical Trial 2023: MitoQ Highlights & Side Effects. Trial Name: NCT04851288 — Phase 2
MitoQ (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04851288 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this experiment still open?

"Affirmative, the information located on clinicaltrials.gov suggests that this medical experiment is actively recruiting participants. This trial was first published in April 2021 and last modified in July 2022, with a total of 112 volunteers expected to be recruited from 1 site."

Answered by AI

How many persons are being included in this trial?

"Affirmative. According to data on clinicaltrials.gov, this investigation is still recruiting patients since its initial posting in April of 2021 and latest update in July 2022. The desired sample size involves 112 individuals from a single site."

Answered by AI

What potential risks come with the administration of MitoQ?

"MitoQ's safety is rated a 2, as the Phase 2 status implies that there are some studies confirming its safety but none attesting to its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mitochondrial-targeted Antioxidant Supplementation for Improving Age-related Vascular Dysfunction in Humans
Douglas Seals 2021. "Mitochondrial-targeted Antioxidant Supplementation for Improving Age-related Vascular Dysfunction in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04851288.
~33 spots leftby Aug 2025
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