Trial Outcomes & Findings for Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients (NCT NCT03506633)

Last Updated: 2025-04-01

Results Overview

Flow-mediated dilation will be used to measure vasodilation in the brachial artery, and blood flow in the femoral and popliteal arteries. This is measured in percents. Scale range is approximately 8-12% for healthy populations. A higher value represents a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

2 days

Results posted on

2025-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	MitoQ-Placebo Subjects will be tested on two different days, first day will be baseline and MitoQ and second day will be Placebo. Testing will take place forty-minutes after MitoQ/placebo intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Placebo-MitoQ Subjects will be tested on two different days, first day will be baseline and Placebo and second day will be MitoQ. Testing will take place forty-minutes after placebo/MitoQ intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.
First Intervention (1 Day) STARTED	8	6
First Intervention (1 Day) COMPLETED	8	6
First Intervention (1 Day) NOT COMPLETED	0	0
Washout (14 Days) STARTED	8	6
Washout (14 Days) COMPLETED	7	6
Washout (14 Days) NOT COMPLETED	1	0
Second Intervention (1 Day) STARTED	7	6
Second Intervention (1 Day) COMPLETED	7	6
Second Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MitoQ-Placebo Subjects will be tested on two different days, first day will be baseline and MitoQ and second day will be Placebo. Testing will take place forty-minutes after MitoQ/placebo intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Placebo-MitoQ Subjects will be tested on two different days, first day will be baseline and Placebo and second day will be MitoQ. Testing will take place forty-minutes after placebo/MitoQ intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.
Washout (14 Days) Withdrawal by Subject	1	0

Baseline Characteristics

Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MitoQ-Placebo n=7 Participants Subjects will be tested on two different days, first day will be baseline and MitoQ and second day will be Placebo. Testing will take place forty-minutes after MitoQ/placebo intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Placebo-MitoQ n=6 Participants Subjects will be tested on two different days, first day will be baseline and Placebo and second day will be MitoQ. Testing will take place forty-minutes after placebo/MitoQ intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	71.5 years STANDARD_DEVIATION 8.4 • n=5 Participants	71.5 years STANDARD_DEVIATION 8.4 • n=7 Participants	71.5 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Outcome measures

Outcome measures
Measure	MitoQ n=13 Participants Subjects will be tested on two different days, first day will be baseline and MitoQ and second day will be Placebo. Testing will take place forty-minutes after MitoQ/placebo intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Placebo n=13 Participants Subjects will be tested on two different days, first day will be baseline and Placebo and second day will be MitoQ. Testing will take place forty-minutes after placebo/MitoQ intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.
Endothelial Function	6.13 % dilation Standard Deviation 2.1	3.78 % dilation Standard Deviation 1.13

SECONDARY outcome

Timeframe: 2 days (1 day for MitoQ and 1 day for Placebo)

Subject will walk on a treadmill starting at a speed of 2.0 mph for two minutes with 0% incline. Every two minutes the treadmill incline will increase by 2% up to a maximum of 14%. The subject will be asked to walk until they feel pain in there legs, at which point the test will stop. This is measured in meters (distance) and seconds (time). Scale range is \~800 meters and 840 for healthy populations. A higher value represents a better outcome. This assessment occurred on two separate days (one for each intervention).

Outcome measures

Outcome measures
Measure	MitoQ n=13 Participants Subjects will be tested on two different days, first day will be baseline and MitoQ and second day will be Placebo. Testing will take place forty-minutes after MitoQ/placebo intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Placebo n=13 Participants Subjects will be tested on two different days, first day will be baseline and Placebo and second day will be MitoQ. Testing will take place forty-minutes after placebo/MitoQ intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.
Walking Function	451.07 meters Standard Deviation 217.14	404.49 meters Standard Deviation 218.09

SECONDARY outcome

Timeframe: 2 days

Blood draws will be taken to measure oxidative stress markers in the blood. This is measured in units per milliliter (U/mL). Measures of oxidative stress are approximately 70-80 U/mL in healthy populations. A lower value represents a better outcome.

Outcome measures

Outcome measures
Measure	MitoQ n=13 Participants Subjects will be tested on two different days, first day will be baseline and MitoQ and second day will be Placebo. Testing will take place forty-minutes after MitoQ/placebo intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Placebo n=13 Participants Subjects will be tested on two different days, first day will be baseline and Placebo and second day will be MitoQ. Testing will take place forty-minutes after placebo/MitoQ intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.
Oxidative Stress	29.55 U/mL Standard Error 1.62	34.14 U/mL Standard Error 0.98

SECONDARY outcome

Timeframe: 2 days

Near-infrared spectroscopy will be used to measure leg muscle oxygenation. Measures of oxygenation are measured in percents. Scale range is \~70-90% in healthy populations. A higher value represents a better outcome.

Outcome measures

Outcome measures
Measure	MitoQ n=13 Participants Subjects will be tested on two different days, first day will be baseline and MitoQ and second day will be Placebo. Testing will take place forty-minutes after MitoQ/placebo intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Placebo n=13 Participants Subjects will be tested on two different days, first day will be baseline and Placebo and second day will be MitoQ. Testing will take place forty-minutes after placebo/MitoQ intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.
Skeletal Muscle Oxygenation	48.1 percentage of oxygenation Standard Deviation 19.3	30.7 percentage of oxygenation Standard Deviation 18.2

SECONDARY outcome

Timeframe: 2 days

Autonomic nervous system function will be measured non-invasively using heart rate variability via the head-up tilt test. Raw R-R interval data will be converted to time frequency domain with the wavelet transform across the frequency intervals 0.04-0.15 Hz (low-frequency, (LF)) and 0.15-0.4 Hz (high-frequency, HF). Units for both will be expressed as ms\^2. Final outcome measure will be the ratio of LF/HF, which is a unitless ratio to indicate sympathetic-to-parasympathetic nervous system function.

Outcome measures

Outcome measures
Measure	MitoQ n=13 Participants Subjects will be tested on two different days, first day will be baseline and MitoQ and second day will be Placebo. Testing will take place forty-minutes after MitoQ/placebo intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Placebo n=13 Participants Subjects will be tested on two different days, first day will be baseline and Placebo and second day will be MitoQ. Testing will take place forty-minutes after placebo/MitoQ intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.
Autonomic Nervous System Activity	3.6 ratio Standard Deviation 2.3	2.7 ratio Standard Deviation 1.8

SECONDARY outcome

Timeframe: 2 days

Microvascular function will be assessed using near-infrared spectroscopy. NIRS measurements were taken continuously throughout the entire protocol at a sampling rate of 10 Hz. Hemoglobin and myoglobin possess indistinguishable spectral characteristics in the NIRS signal; therefore, the signal is considered to be primarily derived from Hb. The signals were analyzed according to a modified Beer- Lambert's law, and a constant differential path length factor was not used due to the assumption that constant optical scattering of the photons has been demonstrated to affect alterations in NIRS signals. Data were expressed as relative changes with respect to baseline as a percentage (TOI). Tissue reoxygenation was estimated by calculating the initial slope of TOI recovery, which has been used as an index of microvascular function.

Outcome measures

Outcome measures
Measure	MitoQ n=13 Participants Subjects will be tested on two different days, first day will be baseline and MitoQ and second day will be Placebo. Testing will take place forty-minutes after MitoQ/placebo intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.	Placebo n=13 Participants Subjects will be tested on two different days, first day will be baseline and Placebo and second day will be MitoQ. Testing will take place forty-minutes after placebo/MitoQ intake. There will be a 2-week washout between testing days. MitoQ: A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.
Microvascular Function	48.1 % reoxygenation rate Standard Deviation 18.8	32.3 % reoxygenation rate Standard Deviation 17.9

Adverse Events

MitoQ

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Song-Young Park

University of Nebraska at Omaha

Phone: 402-554-3374

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place