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Completed

NCT Number: NCT02597023

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

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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Key information

Conditions

Age range

60 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Translational Research Center

Boulder, Colorado, 80309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MitoQ

Drug

Mitoquinone pill, 20 mg/day

Other names: mitoquinone

Placebo

Drug

Placebo pill with inert excipient, 1 time/day

Other names: placebo pill

Primary outcomes

  1. Endothelium-dependent dilation

    Time frame: 6 weeks

    Flow-mediated dilation

Secondary outcomes

  1. Systemic markers of oxidative stress

    Time frame: 6 weeks

    Oxidized LDL levels in blood.

  2. Motor function

    Time frame: 6 weeks

    NIH Toolbox motor test battery

  3. Cognitive function

    Time frame: 6 weeks

    NIH Toolbox cognition test battery

  4. Arterial Stiffness

    Time frame: 6 weeks

    Aortic pulse wave velocity

  5. Endothelial cell markers of oxidative stress

    Time frame: 6 weeks

    Nitrotyrosine levels in biopsied endothelial cells.

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2015
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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