The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
- Registration Number
- NCT02597023
- Lead Sponsor
- University of Colorado, Boulder
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MitoQ MitoQ MitoQ, 20 mg per day for six weeks MitoQ Placebo MitoQ, 20 mg per day for six weeks Placebo MitoQ Placebo, inert excipient, one time per day for six weeks Placebo Placebo Placebo, inert excipient, one time per day for six weeks
- Primary Outcome Measures
Name Time Method Endothelium-dependent dilation 6 weeks Flow-mediated dilation
- Secondary Outcome Measures
Name Time Method Systemic markers of oxidative stress 6 weeks Oxidized LDL levels in blood.
Motor function 6 weeks NIH Toolbox motor test battery
Cognitive function 6 weeks NIH Toolbox cognition test battery
Arterial Stiffness 6 weeks Aortic pulse wave velocity
Endothelial cell markers of oxidative stress 6 weeks Nitrotyrosine levels in biopsied endothelial cells.
Trial Locations
- Locations (1)
Clinical Translational Research Center
🇺🇸Boulder, Colorado, United States
Clinical Translational Research Center🇺🇸Boulder, Colorado, United States