MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes (MITO)

MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes (MITO Study)

Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. Preliminary data shows a single bout of ischemic conditioning or oral ingestion of an over-the-counter antioxidant supplement called MitoQ may improve vascular function and muscle activity in individuals post-stroke.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Ischemic Conditioning; Dietary supplement: Antioxidant Supplement

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jennifer Nguyen; Phone Number: 414-955-5713; Email: jnguyen@mcw.edu
• Study Contact Backup: Name: Alicen Whitaker-Hilbig, DPT, PhD; Phone Number: 414-955-5713; Email: awhitakerhilbig@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: Matthew J Durand, Ph.D.; Phone Number: 414-955-5619; Email: mdurand@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 - 85 years of age
• Cortical or sub-cortical stroke ≥ 6 months ago with residual hemiparesis
• Able to give informed consent and follow 2-step command.
• English Speaking

Exclusion Criteria:

• Unable to stand from chair without physical assistance from another person (able to use assistive device).
• History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
• Chronic lasting symptoms (> 6 months) of severe COVID-19 (i.e., hospitalization)
• History of head trauma or concussion within the past 6 months
• Comorbid neurological disorder
• Peripheral vascular disease
• Myocardial infarction or arrhythmia in the previous year
• Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
• Pregnant or breastfeeding.
• Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ischemic Conditioning - High; During each testing session, the investigators will be measuring how one treatment of ischemic conditioning affects blood flow and muscle function. One day participants will receive a high cuff inflation pressure on the leg, called ischemic conditioning - high (225 mmHg).	Device: Ischemic Conditioning; The cuff will be placed around the proximal, non-affected thigh and inflated for 5 minutes in a supine or semi-reclined position, then released for a 5-minute recovery period. Five cycles of inflation and recovery will be performed (45 minutes total).These inflations will be done using a cuff similar to what is used for taking blood pressure.
Experimental: Ischemic Conditioning - Low; During each testing session, the investigators will be measuring how one treatment of ischemic conditioning affects blood flow and muscle function. One day participants will receive a low cuff inflation pressure on the leg, called ischemic conditioning - low (25 mmHg).	Device: Ischemic Conditioning; The cuff will be placed around the proximal, non-affected thigh and inflated for 5 minutes in a supine or semi-reclined position, then released for a 5-minute recovery period. Five cycles of inflation and recovery will be performed (45 minutes total).These inflations will be done using a cuff similar to what is used for taking blood pressure.
Experimental: Antioxidant Supplement; During each testing session, the investigators will be measuring how one treatment of an over-the-counter antioxidant supplement affects blood flow and muscle function. One day participants will orally ingest an over-the-counter antioxidant supplement called MitoQ.	Dietary supplement: Antioxidant Supplement; MitoQ is an over the counter supplement that increases delivery to the mitochondria. Similar to studies performed in middle age/older adults and individuals with peripheral arterial disease, we will administer 1 single oral dose of 80mg of MitoQ or a placebo pill. As MitoQ reaches peak concentrations at ~40 to 60 minutes after ingestion, we will wait 45 minutes (time matched to Ischemic conditioning).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brachial Artery Flow-Mediated Dilation	We will measure brachial artery vascular health in the non-paretic arm. Baseline brachial artery diameter and blood flow velocity through the artery will be measured before and after a pneumatic forearm cuff is inflated to 225 mmHg for five minutes.	Change from BL to Post Intervention (5 hours)
Microvascular Vasodilation	Laser Doppler Flowmetry (LDF) with Dermal Microdialysis (DM) will measure blood flow flux during microinfusions of study drugs (limited to an area on the skin approximately the size of a nickel) to examine endothelial dependent vasodilation (Acetylcholine, ACh) and nitric-oxide mediated vasodilation (ACH +/- LNAME, and endothelial nitric oxide synthase inhibitor).	Change from BL to Post Intervention (5 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Tissue Oxygenation	We will also place a near-infrared spectroscopy (NIRS) pad on the thenar eminence of the non-paretic hand to non-invasively measure tissue oxygenation via infrared light following the pneumatic forearm cuff inflation/deflation.	Change from BL to Post Intervention (5 hours)
Blood Draw	We will collect blood before and after the intervention via an in-dwelling intravenous catheter. The blood draw analysis may include but will not be limited to examining complete blood counts, glucose levels, cholesterol, and plasma redox and bioenergetic analyses.	Change from BL to Post Intervention (5 hours)

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Matthew Durand, PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Antioxidant; Reactive Oxygen Species; Blood Flow; Flow-Mediated Dilation; Supplement; Ischemic Conditioning; Microvascular Health
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: PRO00054821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No