NCT02597023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 12, 2018

Status Verified

March 1, 2018

Enrollment Period

2.3 years

First QC Date

October 30, 2015

Last Update Submit

April 11, 2018

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

  • Endothelium-dependent dilation

    Flow-mediated dilation

    6 weeks

Secondary Outcomes (5)

  • Systemic markers of oxidative stress

    6 weeks

  • Motor function

    6 weeks

  • Cognitive function

    6 weeks

  • Arterial Stiffness

    6 weeks

  • Endothelial cell markers of oxidative stress

    6 weeks

Study Arms (2)

MitoQ

EXPERIMENTAL

MitoQ, 20 mg per day for six weeks

Drug: MitoQDrug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo, inert excipient, one time per day for six weeks

Drug: MitoQDrug: Placebo

Interventions

MitoQDRUG

Mitoquinone pill, 20 mg/day

Also known as: mitoquinone
MitoQPlacebo
PlaceboDRUG

Placebo pill with inert excipient, 1 time/day

Also known as: placebo pill
MitoQPlacebo

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \>1 year.
  • Ability to provide informed consent
  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Translational Research Center

Boulder, Colorado, 80309, United States

Location

Related Publications (1)

  • 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.

    PMID: 29661838DERIVED

Related Links

MeSH Terms

Interventions

mitoquinone

Study Officials

  • Matthew J Rossman, PhD

    University of Colorado, Boulder

    STUDY DIRECTOR

  • Douglas R Seals, PhD

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 4, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 12, 2018

Record last verified: 2018-03

Locations

US(1)