MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes

NCT06930638 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: PRO00054821
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Ischemic Conditioning; Blood Flow; Microvascular Health; Flow-Mediated Dilation; Antioxidant; Reactive Oxygen Species; Supplement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Muscle Tissue Oxygenation

  Change from BL to Post Intervention (5 hours)

• Blood Draw

  Change from BL to Post Intervention (5 hours)

Study Arms (3)

Ischemic Conditioning - High

EXPERIMENTAL

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

Ischemic Conditioning - Low

EXPERIMENTAL

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

Antioxidant Supplement

EXPERIMENTAL

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

Interventions

Ischemic Conditioning DEVICE

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.

Ischemic Conditioning - High; Ischemic Conditioning - Low

Antioxidant Supplement DIETARY_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).

Antioxidant Supplement

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matthew Durand, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Nguyen

CONTACT

414-955-5713; jnguyen@mcw.edu

Alicen Whitaker-Hilbig, DPT, PhD

CONTACT

414-955-5713; awhitakerhilbig@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)