Clinical trial NCT02597023: The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
Official title: The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 55
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Endothelium-dependent dilation
timeFrame: 6 weeks
Secondary outcomes:
measure: Systemic markers of oxidative stress
timeFrame: 6 weeks
measure: Motor function
timeFrame: 6 weeks
measure: Cognitive function
timeFrame: 6 weeks
measure: Arterial Stiffness
timeFrame: 6 weeks
measure: Endothelial cell markers of oxidative stress
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Clinical Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Matthew J Rossman, PhD
role: STUDY_DIRECTOR
affiliation: University of Colorado, Boulder
name: Douglas R Seals, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.