HealthyMitoQ/muscleNCT04098510
Concentration of MitoQ in Human Skeletal Muscle
A study testing MitoQ in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MitoQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Sep 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy,
- Male
- 18-40 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
August Krogh Building
Copenhagen
Morten Hostrup, PhD, +4524474785, mhostrup@nexs.ku.dk
Matteo Fiorenza, PhD
About this study
Official title: Concentration of Mitoquinone Mesylate in Skeletal Muscle After a Single Oral Dose of MitoQ
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.
- Conditions
- Healthy
- Being tested
- MitoQ
- Keywords
- Mitochondria-targeted antioxidant, Skeletal muscle biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQDietary supplement
Subjects ingest 8x20 mg MitoQ capsules
| Study group | Role | What they receive |
|---|---|---|
| MitoQ | Experimental | Subjects ingest 160 mg of MitoQ Receives: Dietary Supplement: MitoQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mitoquinone mesylate concentration
Concentration of mitoquinone mesylate in skeletal muscle
Measured: Before oral administration of MitoQ
Muscle mitoquinone mesylate concentration
Concentration of mitoquinone mesylate in skeletal muscle
Measured: 1 hours after oral administration of MitoQ
Muscle mitoquinone mesylate concentration
Concentration of mitoquinone mesylate in skeletal muscle
Measured: 3 hours after oral administration of MitoQ
Muscle mitoquinone mesylate concentration
Concentration of mitoquinone mesylate in skeletal muscle
Measured: 5 hours after oral administration of MitoQ
Secondary outcomes (1)
Blood mitoquinone mesylate concentration
Concentration of mitoquinone mesylate in venous blood
Measured: Before as well as 0.5, 1, 1.5, 2, 3, 4 and 5 hours after oral administration of MitoQ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start8 Sep 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098510
- Sponsor's protocol ID
- MitoQ
- Acronym
- MitoQ/muscle
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentration of Mitoquinone Mesylate in Skeletal Muscle After a Single Oral Dose of MitoQ
- ClinicalTrials.gov ID
- NCT04098510
- Acronym / sponsor ID
- MitoQ/muscle / MitoQ
- Conditions
- Healthy
- Keywords
- Mitochondria-targeted antioxidant, Skeletal muscle biopsies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitoQ | Experimental | Dietary Supplement: MitoQSubjects ingest 160 mg of MitoQ |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy,
- Male
- 18-40 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitoQSubjects ingest 8x20 mg MitoQ capsules | Dietary supplement | MitoQ |
Primary outcome
Muscle mitoquinone mesylate concentration
Time frame: Before oral administration of MitoQ
Concentration of mitoquinone mesylate in skeletal muscle
Muscle mitoquinone mesylate concentration
Time frame: 1 hours after oral administration of MitoQ
Concentration of mitoquinone mesylate in skeletal muscle
Muscle mitoquinone mesylate concentration
Time frame: 3 hours after oral administration of MitoQ
Concentration of mitoquinone mesylate in skeletal muscle
Muscle mitoquinone mesylate concentration
Time frame: 5 hours after oral administration of MitoQ
Concentration of mitoquinone mesylate in skeletal muscle
1 secondary outcome
Blood mitoquinone mesylate concentration
Time frame: Before as well as 0.5, 1, 1.5, 2, 3, 4 and 5 hours after oral administration of MitoQ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitoQ in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mitoquinone mesylate concentration (time frame: Before oral administration of MitoQ). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.