AgingNCT02597023
The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
A study testing MitoQ in people with Aging, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of supplementation with the mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- MitoQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Dec 2017
- 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 60 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for >1 year.
- Ability to provide informed consent
- Baseline brachial flow-mediated dilation (FMD) < 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.
- Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
- Willing to accept random assignment to condition
Who cannot join
- Current smoking
- Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders
- Body mass index (BMI) >40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
- Chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive functions [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain diseases of aging]), except hypertension and hyperlipidemia
- Regular vigorous aerobic/endurance exercise (>3 vigorous bouts/week).
- Not weight stable in the prior 3 months (>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function.
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- Current treatment or recent cessation (< 3 mo) of hormone replacement therapy
- Moderate or severe peripheral artery disease (ankle-brachial index <0.7).
- A graded exercise test will be performed by all subjects, if there is physician concern or an adverse event, the subject will not participate in a maximal oxygen consumption (VO2max) test (this will be determined in accordance with stated contraindications for exercise testing provided by the American Heart Association).
- Thyroid disease that is not controlled by medications or <3 month's use of a particular medication and/or dosage (uncontrolled thyroid diseases are associated with alterations in vascular function).
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Translational Research Center
Boulder, Colorado, 80309
About this study
The purpose of this study is to assess the efficacy of supplementation with the mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults.
Read the detailed description
Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.
- Conditions
- Aging
- Being tested
- MitoQ, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQDrug
Also called mitoquinone
Mitoquinone pill, 20 mg/day
PlaceboDrug
Also called placebo pill
Placebo pill with inert excipient, 1 time/day
| Study group | Role | What they receive |
|---|---|---|
| MitoQ | Experimental | MitoQ, 20 mg per day for six weeks Receives: Drug: MitoQ; Drug: Placebo |
| Placebo | Placebo comparator | Placebo, inert excipient, one time per day for six weeks Receives: Drug: MitoQ; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelium-dependent dilation
Flow-mediated dilation
Measured: 6 weeks
Secondary outcomes (5)
Systemic markers of oxidative stress
Oxidized LDL levels in blood.
Measured: 6 weeks
Motor function
NIH Toolbox motor test battery
Measured: 6 weeks
Cognitive function
NIH Toolbox cognition test battery
Measured: 6 weeks
Arterial Stiffness
Aortic pulse wave velocity
Measured: 6 weeks
Endothelial cell markers of oxidative stress
Nitrotyrosine levels in biopsied endothelial cells.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew J Rossman, PhD, Study director, University of Colorado, BoulderDouglas R Seals, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597023
- Sponsor's protocol ID
- 15-0402
- Status last verified
- Mar 2018
- First submitted
- 30 Oct 2015
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rossman MJ, Santos-Parker JR, Steward CAC, Bispham NZ, Cuevas LM, Rosenberg HL, Woodward KA, Chonchol M, Gioscia-Ryan RA, Murphy MP, Seals DR. Chronic Supplementation With a Mitochondrial Antioxidant (MitoQ) Improves Vascular Function in Healthy Older Adults. Hypertension. 2018 Jun;71(6):1056-1063. doi: 10.1161/HYPERTENSIONAHA.117.10787. Epub 2018 Apr 16.
PubMed 29661838
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
- ClinicalTrials.gov ID
- NCT02597023
- Acronym / sponsor ID
- 15-0402
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Nov 2015 (estimated)
- 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 assess the efficacy of supplementation with the mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults.
Detailed description
Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MitoQ | Experimental | Drug: MitoQ, Drug: PlaceboMitoQ, 20 mg per day for six weeks |
| Placebo | Placebo comparator | Drug: MitoQ, Drug: PlaceboPlacebo, inert excipient, one time per day for six weeks |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for >1 year.
- Ability to provide informed consent
- Baseline brachial flow-mediated dilation (FMD) < 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.
- Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
- Willing to accept random assignment to condition
Key exclusion criteria (10 listed)
- Current smoking
- Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders
- Body mass index (BMI) >40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
- Chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive functions [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain diseases of aging]), except hypertension and hyperlipidemia
- Regular vigorous aerobic/endurance exercise (>3 vigorous bouts/week).
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 |
|---|---|---|
| MitoQAlso: mitoquinoneMitoquinone pill, 20 mg/day | Drug | MitoQ, Placebo |
| PlaceboAlso: placebo pillPlacebo pill with inert excipient, 1 time/day | Drug | MitoQ, Placebo |
Primary outcome
Endothelium-dependent dilation
Time frame: 6 weeks
Flow-mediated dilation
5 secondary outcomes
Systemic markers of oxidative stress
Time frame: 6 weeks
Motor function
Time frame: 6 weeks
Cognitive function
Time frame: 6 weeks
Arterial Stiffness
Time frame: 6 weeks
Endothelial cell markers of oxidative stress
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Derived from this study: PubMed 29661838Rossman MJ, Santos-Parker JR, Steward CAC, Bispham NZ, Cuevas LM, Rosenberg HL, Woodward KA, Chonchol M, Gioscia-Ryan RA, Murphy MP, Seals DR. Chronic Supplementation With a Mitochondrial Antioxidant (MitoQ) Improves Vascular Function in Healthy Older Adults. Hypertension. 2018 Jun;71(6):1056-1063. doi: 10.1161/HYPERTENSIONAHA.117.10787. Epub 2018 Apr 16.
- Description of our Research LaboratoryLink provided by the sponsor.
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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.
Matthew J Rossman, PhD study director
University of Colorado, Boulder
Douglas R Seals, PhD principal investigator
University of Colorado, Boulder
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 Aging, run by University of Colorado, Boulder 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 12 Apr 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endothelium-dependent dilation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597023, which also lists 1 linked publication.
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 12 Apr 2018.