The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-80
SponsorUConn Health
About this trial
The goal of this clinical trial is to test the effects of MitoQ supplementation in older adults and frail older adults with physical dysfunction and/or cognitive dysfunction. The main question\[s\] it aims to answer are:
* To compare vascular function, oxidative stress levels, and physical and cognitive function among older adults and frail older adults with physical and cognitive dysfunction * To determine whether MitoQ supplementation has the potential to improve vascular function in central and cerebral vessels * To determine whether MitoQ supplementation can enhance physical and cognitive capabilities.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
men and women aged 65-80 with a slow gait speed (0.4m/s based on a 4m walk) and/or mild cognitive impairment.
good cardiovascular health (not taking any blood pressure/flow/metabolism altering medications)
Disqualifiers
A vaccination in past two weeks
Recent acute infection three weeks prior to enrollment
Known immunodeficiency (including HIV infection, primary immunodeficiency, any history of chemotherapy or radiotherapy
Use of medicines during past 6 months known to alter immune response such as high- dose corticosteroids
Trial design
Design model
Crossover
Treatments tested in this trial
Mitoquinone Mesylate
DrugMitoQ given 20 mg per day for 12 weeks.
Placebo capsule
Dietary supplementPlacebo capsule taken every day for 12 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Placebo capsulePlacebo comparator 1 intervention
Group B: MitoQ capsuleExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Vascular Endothelial Function
Assess Femoral artery through Passive Leg Movement and Brachial artery flow-mediated dilation (% \[relative\] and mm \[absolute\])
Time frame
4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)2
Change in Cerebrovascular Function
Utilize ultrasound to measure a change in blood flow velocity in response to a breathing test (cm/s)
Time frame
4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)3
Change in NIH Tool Box Composite
NIH Toolbox Cognitive Battery is a multidimensional set of brief measures assessing cognitive (as well as emotional, motor and sensory) function. There is no score range, but mean score is 100 with standard deviation 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.
Time frame
4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)4
Change in walking speed
Gait speed calculated from 10 meter walk test. Only the 6 intermediate meters are recorded. Time is recorded by a manual chronometer. 3 records are done, mean time is calculated. Mean time is divided by 6 to obtain mean gait speed
Time frame
4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)Secondary outcomes
1
Change in Mitochondrial Function measured in peripheral blood mononuclear cells (PBMCs)
Measure mitochondrial respiratory function using peripheral blood mononuclear cells (PBMCs) using oroboros O2k system expressed by O2flux in pmol/second/cell numbers
Time frame
4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)2
Change in Oxidative Stress measured in peripheral blood mononuclear cells (PBMCs) by O2flux in pmol/second/cell numbers
Measure Mitochondrial-derived reactive oxygen species (ROS) using peripheral blood mononuclear cells (PBMCs) using oroboros O2k system expressed by Amplex flux in pmol/second/cell numbers
Time frame
4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
UConn Health
Lead sponsor
University of Connecticut
Sponsor institution
National Institute on Aging (NIA)
Collaborator
University of Connecticut
Collaborator
Source ClinicalTrials.gov