Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients

NCT03506633 | Completed Results

• 1 other identifier: 0086-18-FB
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral artery disease (PAD) is a common cardiovascular disease, in which narrowed arteries reduce blood flow to the limbs, causing pain, immobility and in some cases amputation or death. PAD patients have shown higher levels of systemic and skeletal muscle inflammation due to the impaired oxygen transfer capacity of these blood vessels. This attenuated oxygen transfer capacity causes hypoxic conditions in the skeletal muscle and results in mitochondrial dysfunction and elevated reactive oxygen species (ROS). These harmful byproducts of cell metabolism are the major cause of intermittent claudication, defined as pain in the legs that results in significant functional limitations. One potential defensive mechanism to these negative consequences may be having higher antioxidant capacity, which would improve blood vessel vasodilatory function, enabling more blood to transfer to the skeletal muscles. Therefore, the purpose of this project is to examine the impact of mitochondrial targeted antioxidant (MitoQ) intake on oxygen transfer capacity of blood vessels, skeletal muscle mitochondrial function, leg function, and claudication in participants with PAD. Blood vessel oxygen transfer capacity in the leg will be assessed in the femoral and popliteal arteries. Skeletal muscle mitochondrial function and ROS levels will be analyzed in human skeletal muscle via near infrared spectroscopy and through blood samples. Leg function will be assessed by walking on a force platform embedded treadmill and claudication times will be assessed with the Gardner maximal walking distance treadmill test.

Conditions

Peripheral Arterial Disease; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Endothelial Function

  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.

  2 days

Secondary Outcomes (5)

• Walking Function

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

• Oxidative Stress

  2 days

• Skeletal Muscle Oxygenation

  2 days

• Autonomic Nervous System Activity

  2 days

• Microvascular Function

  2 days

Study Arms (2)

MitoQ-Placebo

EXPERIMENTAL

Participants 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.

Dietary Supplement: MitoQ

Placebo-MitoQ

EXPERIMENTAL

Participants 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.

Dietary Supplement: MitoQ

Interventions

MitoQ DIETARY_SUPPLEMENT

A mitochondrial-targeting antioxidant "MitoQ" or a placebo will be given to each participant in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured.

MitoQ-Placebo; Placebo-MitoQ

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written, informed consent
• Demonstrated positive history of chronic claudication
• History of exercise limiting claudication
• Ankle/brachial index \< 0.90 at rest
• Stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks prior to study entry
• years old

You may not qualify if:

• Resting pain or tissue loss due to Peripheral artery disease (PAD), Fontaine stage III and IV
• Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
• Walking capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska - Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Song-Young Park
• Organization: University of Nebraska at Omaha

song-youngpark@unomaha.edu

402-554-3374

Study Officials

• Song-Young Park, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: 1:1 Randomized, cross-over, double-blinded design

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 24, 2018
• Study Start: September 5, 2018
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: April 1, 2025
• Results First Posted: November 12, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)