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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

Tracking Information
First Submitted Date  ICMJE October 30, 2015
First Posted Date  ICMJE November 4, 2015
Last Update Posted Date April 12, 2018
Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2015)		 Endothelium-dependent dilation [ Time Frame: 6 weeks ]
Flow-mediated dilation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2015)
  • Systemic markers of oxidative stress [ Time Frame: 6 weeks ]
    Oxidized LDL levels in blood.
  • Motor function [ Time Frame: 6 weeks ]
    NIH Toolbox motor test battery
  • Cognitive function [ Time Frame: 6 weeks ]
    NIH Toolbox cognition test battery
  • Arterial Stiffness [ Time Frame: 6 weeks ]
    Aortic pulse wave velocity
  • Endothelial cell markers of oxidative stress [ Time Frame: 6 weeks ]
    Nitrotyrosine levels in biopsied endothelial cells.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
Official Title  ICMJE The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aging
Intervention  ICMJE
  • Drug: MitoQ
    Mitoquinone pill, 20 mg/day
    Other Name: mitoquinone
  • Drug: Placebo
    Placebo pill with inert excipient, 1 time/day
    Other Name: placebo pill
Study Arms  ICMJE
  • Experimental: MitoQ
    MitoQ, 20 mg per day for six weeks
    Interventions:
    • Drug: MitoQ
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo, inert excipient, one time per day for six weeks
    Interventions:
    • Drug: MitoQ
    • Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2015)		 55
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02597023
Other Study ID Numbers  ICMJE 15-0402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Colorado, Boulder
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Colorado, Boulder
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Matthew J Rossman, PhD University of Colorado, Boulder
Principal Investigator: Douglas R Seals, PhD University of Colorado, Boulder
PRS Account University of Colorado, Boulder
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP