Aging
Conditions
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.
Interventions
DRUGMitoQ
Mitoquinone pill, 20 mg/day
DRUGPlacebo
Placebo pill with inert excipient, 1 time/day
Sponsors
University of Colorado, Boulder
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 79 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelium-dependent dilation | 6 weeks | Flow-mediated dilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed