The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
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ClinicalTrials.gov Identifier: NCT02597023 |
Recruitment Status :
Completed
First Posted : November 4, 2015
Last Update Posted : April 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aging | Drug: MitoQ Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | December 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: MitoQ
MitoQ, 20 mg per day for six weeks
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Drug: MitoQ
Mitoquinone pill, 20 mg/day
Other Name: mitoquinone Drug: Placebo Placebo pill with inert excipient, 1 time/day
Other Name: placebo pill |
Placebo Comparator: Placebo
Placebo, inert excipient, one time per day for six weeks
|
Drug: MitoQ
Mitoquinone pill, 20 mg/day
Other Name: mitoquinone Drug: Placebo Placebo pill with inert excipient, 1 time/day
Other Name: placebo pill |
- Endothelium-dependent dilation [ Time Frame: 6 weeks ]Flow-mediated dilation
- Systemic markers of oxidative stress [ Time Frame: 6 weeks ]Oxidized LDL levels in blood.
- Motor function [ Time Frame: 6 weeks ]NIH Toolbox motor test battery
- Cognitive function [ Time Frame: 6 weeks ]NIH Toolbox cognition test battery
- Arterial Stiffness [ Time Frame: 6 weeks ]Aortic pulse wave velocity
- Endothelial cell markers of oxidative stress [ Time Frame: 6 weeks ]Nitrotyrosine levels in biopsied endothelial cells.

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Ages Eligible for Study: | 60 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597023
United States, Colorado | |
Clinical Translational Research Center | |
Boulder, Colorado, United States, 80309 |
Study Director: | Matthew J Rossman, PhD | University of Colorado, Boulder | |
Principal Investigator: | Douglas R Seals, PhD | University of Colorado, Boulder |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Colorado, Boulder |
ClinicalTrials.gov Identifier: | NCT02597023 |
Other Study ID Numbers: |
15-0402 |
First Posted: | November 4, 2015 Key Record Dates |
Last Update Posted: | April 12, 2018 |
Last Verified: | March 2018 |