NCT04098510

Brief Summary

The purpose of this study is to determine mitoquinone mesylate concentration levels in skeletal muscle samples obtained after intake of an acute oral dose of MitoQ.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 18, 2019

Last Update Submit

September 20, 2019

Conditions

Healthy

Keywords

Mitochondria-targeted antioxidantSkeletal muscle biopsies

Outcome Measures

Primary Outcomes (4)

  • Muscle mitoquinone mesylate concentration

    Concentration of mitoquinone mesylate in skeletal muscle

    Before oral administration of MitoQ

  • Muscle mitoquinone mesylate concentration

    Concentration of mitoquinone mesylate in skeletal muscle

    1 hours after oral administration of MitoQ

  • Muscle mitoquinone mesylate concentration

    Concentration of mitoquinone mesylate in skeletal muscle

    3 hours after oral administration of MitoQ

  • Muscle mitoquinone mesylate concentration

    Concentration of mitoquinone mesylate in skeletal muscle

    5 hours after oral administration of MitoQ

Secondary Outcomes (1)

  • Blood mitoquinone mesylate concentration

    Before as well as 0.5, 1, 1.5, 2, 3, 4 and 5 hours after oral administration of MitoQ

Study Arms (1)

MitoQ

EXPERIMENTAL

Subjects ingest 160 mg of MitoQ

Dietary Supplement: MitoQ

Interventions

MitoQDIETARY_SUPPLEMENT

Subjects ingest 8x20 mg MitoQ capsules

MitoQ

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy,
  • Male
  • years of age

You may not qualify if:

  • Previous use of MitoQ or CoQ-10 within 30 days of screening appointment
  • Ongoing use of MitoQ
  • Smoking
  • Ongoing treatment with medications
  • Disease deemed by the MD to infer a risk to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, Denmark

RECRUITING

MeSH Terms

Interventions

mitoquinone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 23, 2019

Study Start

September 8, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)