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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02597023
• Other study ID #: 15-0402
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: April 11, 2018
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

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%? (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).

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• MitoQ
Mitoquinone pill, 20 mg/day
• Placebo
Placebo pill with inert excipient, 1 time/day

Locations

Country	Name	City	State
United States	Clinical Translational Research Center	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelium-dependent dilation	Flow-mediated dilation	6 weeks
Secondary	Systemic markers of oxidative stress	Oxidized LDL levels in blood.	6 weeks
Secondary	Motor function	NIH Toolbox motor test battery	6 weeks
Secondary	Cognitive function	NIH Toolbox cognition test battery	6 weeks
Secondary	Arterial Stiffness	Aortic pulse wave velocity	6 weeks
Secondary	Endothelial cell markers of oxidative stress	Nitrotyrosine levels in biopsied endothelial cells.	6 weeks

External Links

•   Description of our Research Laboratory