HYPEROXIA Responses and ROS
Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences
4 other identifiers
interventional
24
1 country
1
Brief Summary
30 participants (15 males and 15 females) who are ≥18 - ≤ 40 years old and considered healthy will be enrolled into this study to test the role of reactive oxygen species (ROS) in regulating cerebral blood flow (CBF). Participants can expect to be on study for 2 study visits over a 6 month period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2023
CompletedFirst Posted
Study publicly available on registry
July 24, 2023
CompletedStudy Start
First participant enrolled
July 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedAugust 12, 2025
August 1, 2025
8 months
July 6, 2023
August 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Cerebral Blood Flow: Normoxia
Participants will be randomized to AOC or placebo. Normoxia measures will be collected under each condition in the MRI over 2 study visits.
up to 6 months
Cerebral Blood Flow: Hyperoxia
Participants will be randomized to AOC or placebo. Hyperoxia measures will be collected under each condition in the MRI over 2 study visits.
up to 6 months
Study Arms (2)
Antioxidant Cocktail
EXPERIMENTALThe first dose will be 500 mg vitamin C, 200 IU vitamin E, and 300 mg of alpha lipoic acid 120 minutes before MRI. The second dose will be 500 mg vitamin C, 400 IU vitamin E, and 300 mg of alpha lipoic acid 60 minutes before MRI.
Placebo
ACTIVE COMPARATORPlacebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
Interventions
Total dosing of 1000 mg vitamin C, 600 IU vitamin E, and 600 mg of alpha lipoic acid.
Eligibility Criteria
You may qualify if:
- Age between ≥18 - ≤40 years
You may not qualify if:
- Hypertensive
- \>125 mmHg systolic blood pressure; or
- \>80 mmHg diastolic blood pressure
- BMI ≥25 kg/m2
- Fasting blood glucose ≥100 mg/dl
- LDL cholesterol ≥130 mg/dl
- Triglycerides ≥150 mg/dl
- Current diagnosis or history of:
- peripheral vascular disease
- hepatic disease
- renal disease
- lung disease
- gastrointestinal disorders/bleeding
- hematologic disease
- stroke
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William G Schrage, PhD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2023
First Posted
July 24, 2023
Study Start
July 24, 2024
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share