Diastolic DysfunctionNCT03586414
MitoQ Supplementation and Cardiovascular Function in Healthy Men and Women
A study of Diastolic Dysfunction, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diastolic Dysfunction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 - 75 years of age
- sedentary-to-recreationally active (<3 days of vigorous exercise);
- nonsmokers;
- healthy, as determined by medical history, physical examination, standard blood chemistries.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitochondrial Targeted Antioxidant Supplementation and Diastolic Function in Healthy Men and Women
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.
Read the detailed description
Heart failure affects over 5 million American adults and the risk of heart failure increases with age. Diastolic function typically declines with age. Targeting age-related causal factors leading to the decline in diastolic function in both women and men is a major public health initiative. 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 in older adults. As an exploratory aim, the investigators will determine whether there are differences between men and women in response to this supplementation.
- Conditions
- Diastolic Dysfunction
- Being tested
- MITOQUINOL MESYLATE then placebo, Placebo, then MITOQUINOL MESYLATE
- Keywords
- MitoQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MITOQUINOL MESYLATE then placeboDietary supplement
Also called MitoQ, Mitoquinol methanesulfonate
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'.
Placebo, then MITOQUINOL MESYLATEDietary supplement
Also called MitoQ, Mitoquinol methanesulfonate
'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'.
| Study group | Role | What they receive |
|---|---|---|
| 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'. Receives: 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' Receives: Dietary Supplement: Placebo, then MITOQUINOL MESYLATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (5)
Changes in arterial stiffness
Parameters of arterial stiffness will be measured using SphygmoCor XCEL (Atcor) system (pulse-wave velocity [PWV], pulse wave analyses [PWA]).
Measured: Baseline and 4 weeks
Changes in brachial artery flow-mediated dilation
Brachial artery diameter and flow velocity will be acquired and analyzed using Vascular Analysis Tools 5.5.1
Measured: Baseline and 4 weeks
Changes in endothelial function
Measure parameters using digital peripheral arterial tonometry (Endo-PAT 2000)
Measured: Baseline and 4 weeks
Changes in arterial vascular coupling
Measure ratio between arterial stiffness [Ea] and ventricular stiffness [ELv] estimated from echocardiographic measures.
Measured: Baseline and 4 weeks
Changes in mitochondrial function
Measure parameters of mitochondrial respiration using high-resolution respirometry performed on permeabilized PBMCs (Oroboros Oxygraph O2k); perform venous endothelial cell mitochondrial protein analyses (Fusion, Fission proteins, SIRT1, mitoSox, MnSOD) and oxidative stress (nitrotyrosine, NADPHoxidase).
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start1 Aug 2021
- Primary completionJul 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado Nutrition Obesity Research Center (NORC)
- Responsible party
- Sponsor
- Investigators
- Shauna Runchey, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586414
- Sponsor's protocol ID
- 17-1782
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2018
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pending
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Targeted Antioxidant Supplementation and Diastolic Function in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT03586414
- Acronym / sponsor ID
- 17-1782
- Conditions
- Diastolic Dysfunction
- Keywords
- MitoQ
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Colorado Nutrition Obesity Research Center (NORC)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 13 Jul 2018 (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.
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.
Detailed description
Heart failure affects over 5 million American adults and the risk of heart failure increases with age. Diastolic function typically declines with age. Targeting age-related causal factors leading to the decline in diastolic function in both women and men is a major public health initiative. 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 in older adults. As an exploratory aim, the investigators will determine whether there are differences between men and women in response to this supplementation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: 'MITOQUINOL MESYLATE then placebo | Experimental | Dietary 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'. |
| B: Placebo then 'MITOQUINOL MESYLATE' | Experimental | Dietary Supplement: Placebo, then MITOQUINOL MESYLATEPlacebo 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' |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 - 75 years of age
- sedentary-to-recreationally active (<3 days of vigorous exercise);
- nonsmokers;
- healthy, as determined by medical history, physical examination, standard blood chemistries.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| MITOQUINOL MESYLATE then placeboAlso: MitoQ, Mitoquinol methanesulfonateMITOQUINOL 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'. | Dietary supplement | A: 'MITOQUINOL MESYLATE then placebo |
| Placebo, then MITOQUINOL MESYLATEAlso: MitoQ, Mitoquinol methanesulfonate'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'. | Dietary supplement | B: Placebo then 'MITOQUINOL MESYLATE' |
Primary outcome
Changes in diastolic function
Time frame: Baseline and 4 weeks
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.
5 secondary outcomes
Changes in arterial stiffness
Time frame: Baseline and 4 weeks
Changes in brachial artery flow-mediated dilation
Time frame: Baseline and 4 weeks
Changes in endothelial function
Time frame: Baseline and 4 weeks
Changes in arterial vascular coupling
Time frame: Baseline and 4 weeks
Changes in mitochondrial function
Time frame: Baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No. Pending
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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.
Shauna Runchey, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diastolic Dysfunction, run by University of Colorado, Denver at 1 site in United States.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Mar 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in diastolic function (time frame: Baseline and 4 weeks). 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 7 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.