The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MitoQ

MitoQ, 20 mg per day for six weeks

Group Type EXPERIMENTAL

MitoQ

Intervention Type DRUG

Mitoquinone pill, 20 mg/day

Placebo

Intervention Type DRUG

Placebo pill with inert excipient, 1 time/day

Placebo

Placebo, inert excipient, one time per day for six weeks

Group Type PLACEBO_COMPARATOR

MitoQ

Intervention Type DRUG

Mitoquinone pill, 20 mg/day

Placebo

Intervention Type DRUG

Placebo pill with inert excipient, 1 time/day

Interventions

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MitoQ

Mitoquinone pill, 20 mg/day

Intervention Type DRUG

Placebo

Placebo pill with inert excipient, 1 time/day

Intervention Type DRUG

Other Intervention Names

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mitoquinone placebo pill

Eligibility Criteria

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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).

Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes