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

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ClinicalTrials.gov Identifier: NCT02597023
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Boulder

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aging Drug: MitoQ Drug: Placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
Study Start Date : September 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: MitoQ
MitoQ, 20 mg per day for six weeks
 Drug: MitoQ
Mitoquinone pill, 20 mg/day
Other Name: mitoquinone

Drug: Placebo
Placebo pill with inert excipient, 1 time/day
Other Name: placebo pill
Placebo Comparator: Placebo
Placebo, inert excipient, one time per day for six weeks
 Drug: MitoQ
Mitoquinone pill, 20 mg/day
Other Name: mitoquinone

Drug: Placebo
Placebo pill with inert excipient, 1 time/day
Other Name: placebo pill


Outcome Measures
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Primary Outcome Measures :
  1. Endothelium-dependent dilation [ Time Frame: 6 weeks ]
    Flow-mediated dilation


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597023


Locations
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United States, Colorado
Clinical Translational Research Center
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
Investigators
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Study Director: Matthew J Rossman, PhD University of Colorado, Boulder
Principal Investigator: Douglas R Seals, PhD University of Colorado, Boulder
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT02597023    
Other Study ID Numbers: 15-0402
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: March 2018