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

• Sponsor: University of Colorado, Boulder
• Information provided by (Responsible Party): University of Colorado, Boulder

Tracking Information

• First Submitted Date: October 30, 2015
• First Posted Date: November 4, 2015
• Last Update Posted Date: April 12, 2018
• Study Start Date: September 2015
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 3, 2015)

Endothelium-dependent dilation [ Time Frame: 6 weeks ]

Flow-mediated dilation

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02597023 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Aging

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 3, 2015): 55
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02597023
• Other Study ID Numbers: 15-0402
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Colorado, Boulder
• Study Sponsor: University of Colorado, Boulder
• Collaborators: Not Provided

Investigators

• 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