Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 2 of 5 for:    MitoQ

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Colorado, Boulder
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Boulder
ClinicalTrials.gov Identifier:
NCT02597023
First received: October 30, 2015
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
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 Intervention
Aging
Drug: MitoQ
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults

Further study details as provided by University of Colorado, Boulder:

Primary Outcome Measures:
  • Endothelium-dependent dilation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Flow-mediated dilation


Secondary Outcome Measures:
  • Systemic markers of oxidative stress [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Oxidized LDL levels in blood.

  • Motor function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    NIH Toolbox motor test battery

  • Cognitive function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    NIH Toolbox cognition test battery

  • Arterial Stiffness [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Aortic pulse wave velocity

  • Endothelial cell markers of oxidative stress [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Nitrotyrosine levels in biopsied endothelial cells.


Estimated Enrollment: 55
Study Start Date: September 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   60 Years to 79 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02597023

Contacts
Contact: Lauren Cuevas 303-492-3106 lauren.mary.cuevas@colorado.edu
Contact: Matthew J Rossman, PhD 303-492-4568 matthew.rossman@colorado.edu

Locations
United States, Colorado
Clinical Translational Research Center Recruiting
Boulder, Colorado, United States, 80309
Contact: Lauren Cuevas    303-492-3106    cvstudy.cuboulder@gmail.com   
Sponsors and Collaborators
University of Colorado, Boulder
Investigators
Study Director: Matthew J Rossman, PhD University of Colorado, Boulder
Principal Investigator: Douglas R Seals, PhD University of Colorado, Boulder
  More Information

Additional Information:
Responsible Party: University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT02597023     History of Changes
Other Study ID Numbers: 15-0402 
Study First Received: October 30, 2015
Last Updated: September 12, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016