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About
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.
Full 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:
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.
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Inclusion criteria
Exclusion criteria
Hypertensive
BMI ≥25 kg/m2
Fasting blood glucose ≥100 mg/dl
LDL cholesterol ≥130 mg/dl
Triglycerides ≥150 mg/dl
Current diagnosis or history of:
Current smoking, defined as the use of tobacco or nicotine products >5 times in the past 30 days.
Cardiovascular medication use
NSAID sensitivity
Any contraindications of having an MRI
o (e.g. the requirement of anxiolytics in order to complete an MRI scan)
Irregular menstrual cycle (females only)
Medical conditions that can affect the menstrual cycle, such as hyperprolactinemia, prolactinoma, hypercortisolemia, and congenital adrenal hyperplasia (females only)
Pregnancy, breast feeding, or plans to conceive within the next 3 months (females only)
Polycystic ovary syndrome (females only)
Hirsutism defined as unwanted and/or excessive hair growth on the face, chest, or back (females only)
Levonorgestrel intrauterine device (IUD) (females only)
Hormonal birth control will not be allowed in women, in order to control for high variability between type, dose, and route of therapy. However, in discussion with Dr. Davis (Co-I) and Dr. Laura Cooney M.D., physician experts in medical and reproductive endocrinology and infertility, there are two broad exceptions to this birth control criteria:
Primary purpose
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30 participants in 2 patient groups
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Central trial contact
Shawn Bolin, MS
Data sourced from clinicaltrials.gov
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