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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Drug: MitoQ; Drug: Placebo

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
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80309
      • Clinical Translational Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MitoQ; MitoQ, 20 mg per day for six weeks	Drug: MitoQ; Mitoquinone pill, 20 mg/day; Other Names: mitoquinone; Drug: Placebo; Placebo pill with inert excipient, 1 time/day; Other Names: placebo pill
PLACEBO_COMPARATOR: Placebo; Placebo, inert excipient, one time per day for six weeks	Drug: MitoQ; Mitoquinone pill, 20 mg/day; Other Names: mitoquinone; Drug: Placebo; Placebo pill with inert excipient, 1 time/day; Other Names: placebo pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelium-dependent dilation	Flow-mediated dilation	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor function	NIH Toolbox motor test battery	6 weeks
Cognitive function	NIH Toolbox cognition test battery	6 weeks
Systemic markers of oxidative stress	Oxidized LDL levels in blood.	6 weeks
Arterial Stiffness	Aortic pulse wave velocity	6 weeks
Endothelial cell markers of oxidative stress	Nitrotyrosine levels in biopsied endothelial cells.	6 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Investigators: Study Director: Matthew J Rossman, PhD, University of Colorado, Boulder

Publications and helpful links

General 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.

Helpful Links

• Description of our Research Laboratory

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (ESTIMATE): November 4, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 15-0402