MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes

NCT ID: NCT06930638

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-22
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Ischemic Conditioning

Intervention Type: 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 - 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).

Group Type: EXPERIMENTAL

Ischemic Conditioning

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Antioxidant Supplement

Intervention Type: 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).

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Matthew J. Durand

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Durand, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Nguyen

Role: CONTACT

jnguyen@mcw.edu

414-955-5713

Alicen Whitaker-Hilbig, DPT, PhD

Role: CONTACT

awhitakerhilbig@mcw.edu

414-955-5713

Facility Contacts

Matthew J Durand, Ph.D.

Role: primary

mdurand@mcw.edu

414-955-5619

Other Identifiers

PRO00054821

Identifier Type: -

Identifier Source: org_study_id