NCT03586414

Brief Summary

In this pilot study, the investigators will determine whether supplementation with a mitochondrial-targeted antioxidant (Mitoquinone (MitoQ)) improves mitochondrial function, left ventricular diastolic and vascular function.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
52mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Aug 2021Aug 2030

First Submitted

Initial submission to the registry

February 21, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
3.1 years until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

8.9 years

First QC Date

February 21, 2018

Last Update Submit

March 6, 2025

Conditions

Diastolic Dysfunction

Keywords

MitoQ

Outcome Measures

Primary Outcomes (1)

  • Changes in diastolic function

    Echocardiographic measurements of LV function (and structure) will be assessed; primary outcomes include peak early (E) to late (A) mitral inflow velocity ratio and E to peak early (e') mitral annular velocity ratio.

    Baseline and 4 weeks

Secondary Outcomes (5)

  • Changes in arterial stiffness

    Baseline and 4 weeks

  • Changes in brachial artery flow-mediated dilation

    Baseline and 4 weeks

  • Changes in endothelial function

    Baseline and 4 weeks

  • Changes in arterial vascular coupling

    Baseline and 4 weeks

  • Changes in mitochondrial function

    Baseline and 4 weeks

Study Arms (2)

A: 'MITOQUINOL MESYLATE then placebo

EXPERIMENTAL

'MITOQUINOL MESYLATE' administered twice daily for 4 weeks followed by a washout, then placebo capsule administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'.

Dietary Supplement: MITOQUINOL MESYLATE then placebo

B: Placebo then 'MITOQUINOL MESYLATE'

EXPERIMENTAL

Placebo capsule administered twice daily for 4 weeks followed by a washout period, then 'MITOQUINOL MESYLATE' administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'

Dietary Supplement: Placebo, then MITOQUINOL MESYLATE

Interventions

MITOQUINOL MESYLATE then placeboDIETARY_SUPPLEMENT

MITOQUINOL MESYLATE then placebo: 'MITOQUINOL MESYLATE' administered twice daily for 4 weeks followed by a washout, then placebo capsule administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'.

Also known as: MitoQ, Mitoquinol methanesulfonate
A: 'MITOQUINOL MESYLATE then placebo
Placebo, then MITOQUINOL MESYLATEDIETARY_SUPPLEMENT

'Placebo, then MITOQUINOL MESYLATE' : Placebo administered twice daily for 4 weeks followed by a washout, then 'MITOQUINOL MESYLATE' capsule administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'.

Also known as: MitoQ, Mitoquinol methanesulfonate
B: Placebo then 'MITOQUINOL MESYLATE'

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • sedentary-to-recreationally active (\<3 days of vigorous exercise);
  • nonsmokers;
  • healthy, as determined by medical history, physical examination, standard blood chemistries.

You may not qualify if:

  • history of cancer
  • history of cardiovascular disease
  • unwilling or unable to take MitoQ supplement;
  • taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications (e.g., aspirin);
  • taking sex hormone therapy
  • presence of menses within last 1 year;
  • taking any other medications (e.g., antihypertensives, lipid lowering medications) that would interact with MitoQ or impact CV function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

mitoquinone

Study Officials

  • Shauna Runchey, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2018

First Posted

July 13, 2018

Study Start

August 1, 2021

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Pending

Locations

US(1)