NCT05958303

HYPEROXIA Responses and ROS

Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Objective: The current objective is to determine whether biological sex influences CBF control in hyperoxia in healthy young adults without confounds of age or disease. The investigators will address 3 specific questions: 1. Are cerebral vasoconstrictor responses to hyperoxia greater in men? 2. Do all brain regions respond equally, or are there regional differences-possibly varying by sex? 3. Do ROS regulate the decrease in CBF in a sex specific fashion? This study will be conducted in compliance with federal investigational drug regulations (21 CFR 312) and Good Clinical Practice (GCP) guidelines, as well as state law and institutional policies. Study Population: This study includes 30 total participants; (15 males and 15 females) who are ≥18 - ≤ 40 years old and considered healthy. Approach: CBF testing will be performed in research-dedicated MRI systems on UW campus. Participants will experience normoxia followed by hyperoxia conditions during each of the 2 study visits. Study design focuses on the use of an acute oral antioxidant cocktail (AOC) to test ROS signaling as a potential mechanism explaining sex differences in CBF control. To do this, 2 MRI visits in a double-blind placebo-controlled design will be conducted.

Conditions

• Cerebrovascular Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Antioxidant Cocktail	Total dosing of 1000 mg vitamin C, 600 IU vitamin E, and 600 mg of alpha lipoic acid.
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-07-24
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2023-07-24
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States