Cerebrovascular DisordersNCT05958303

HYPEROXIA Responses and ROS

A study testing Antioxidant Cocktail in people with Cerebrovascular Disorders, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Cerebrovascular Disorders
What is being tested?: Antioxidant Cocktail
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 24 Jul 2024to 31 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age between ≥18 - ≤40 years

Who cannot join

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

Show all 38Show fewer

Triglycerides ≥150 mg/dl
Current diagnosis or history of:
peripheral vascular disease
hepatic disease
renal disease
lung disease
gastrointestinal disorders/bleeding
hematologic disease
stroke
myocardial infarction
coronary heart disease
congestive heart failure
heart surgery
prediabetes
diabetes mellitus (type 1, type 2, MODY, or others)
sleep apnea
hypertension
some autoimmune diseases, such as inflammatory bowel disease or systemic lupus erythematosus (exclusion at discretion of reviewing MD)
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:
Copper intrauterine devices (IUDs) will be allowed as they do not change systemic sex hormone levels).
Women currently taking hormonal birth control (i.e. contraceptive pills, patch, ring) for contraception only (not for a medical condition such as those listed in exclusion criteria above) may consider temporarily stopping to become eligible for enrollment. Hormonal birth control must be stopped at least one month prior to Study Visit 1 to provide time for menstruation to resume. Then stoppage continues through the last planned study visit. Screening information will be reviewed by endocrinology physicians to determine eligibility and timing on this issue (details below).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin
Madison, Wisconsin, 53705

Other trials in United States

About this study

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

Read the 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:

Are cerebral vasoconstrictor responses to hyperoxia greater in men?
Do all brain regions respond equally, or are there regional differences-possibly varying by sex?
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
Being tested: Antioxidant Cocktail, Placebo
Medical subject headings: Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Antioxidant CocktailDietary supplement
Also called AOC
Total dosing of 1000 mg vitamin C, 600 IU vitamin E, and 600 mg of alpha lipoic acid.
PlaceboOther
Placebo

Study groups in NCT05958303
Study group	Role	What they receive
Antioxidant Cocktail	Experimental	The 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. Receives: Dietary Supplement: Antioxidant Cocktail
Placebo	Active comparator	Placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cerebral Blood Flow in Normoxia, Male vs Female
Participants will be randomized to AOC or placebo. Normoxia measures will be collected under each condition in the MRI over 2 study visits.
Measured: up to 6 months
Cerebral Blood Flow in Hyperoxia, Male vs Female
Participants will be randomized to AOC or placebo. Hyperoxia measures will be collected under each condition in the MRI over 2 study visits.
Measured: up to 6 months
Lobar Cerebral Blood Flow in Normoxia, Male vs Female
Participants will be randomized to AOC or placebo. Normoxia measures will be collected under each condition in the MRI over 2 study visits. Normoxia measures will be analyzed across brain lobes.
Measured: up to 6 months
Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female
Participants will be randomized to AOC or placebo. Hyperoxia measures will be collected under each condition in the MRI over 2 study visits. Hyperoxia measures will be analyzed across brain lobes.
Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 202431 Mar 2025

First posted24 Jul 2023
Study start24 Jul 2024
Primary completion31 Mar 2025
Study completion31 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05958303
Sponsor's protocol ID: 2023-0850
Other IDs: 1R01HL150361-01, EDUC/KINESIOLOGY, Protocol Version 2/27/2024
Status last verified: Jul 2026
First submitted: 6 Jul 2023
Last updated: 7 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebrovascular Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences
ClinicalTrials.gov ID: NCT05958303
Acronym / sponsor ID: 2023-0850
Conditions: Cerebrovascular Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 24 Jul 2024 (actual)
Primary completion: 31 Mar 2025 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 24 Jul 2023 (actual)
Results: Posted 7 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Are cerebral vasoconstrictor responses to hyperoxia greater in men?
Do all brain regions respond equally, or are there regional differences-possibly varying by sex?
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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Antioxidant Cocktail	Experimental	Dietary Supplement: Antioxidant CocktailThe 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 comparator	Other: PlaceboPlacebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Age between ≥18 - ≤40 years

Key exclusion criteria (38 listed)

Hypertensive
BMI ≥25 kg/m2
Fasting blood glucose ≥100 mg/dl
LDL cholesterol ≥130 mg/dl
Triglycerides ≥150 mg/dl

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Antioxidant CocktailAlso: AOCTotal dosing of 1000 mg vitamin C, 600 IU vitamin E, and 600 mg of alpha lipoic acid.	Dietary supplement	Antioxidant Cocktail
PlaceboPlacebo	Other	Placebo

Primary outcome

Cerebral Blood Flow in Normoxia, Male vs Female
Time frame: up to 6 months
Participants will be randomized to AOC or placebo. Normoxia measures will be collected under each condition in the MRI over 2 study visits.
Cerebral Blood Flow in Hyperoxia, Male vs Female
Time frame: up to 6 months
Participants will be randomized to AOC or placebo. Hyperoxia measures will be collected under each condition in the MRI over 2 study visits.
Lobar Cerebral Blood Flow in Normoxia, Male vs Female
Time frame: up to 6 months
Participants will be randomized to AOC or placebo. Normoxia measures will be collected under each condition in the MRI over 2 study visits. Normoxia measures will be analyzed across brain lobes.
Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female
Time frame: up to 6 months
Participants will be randomized to AOC or placebo. Hyperoxia measures will be collected under each condition in the MRI over 2 study visits. Hyperoxia measures will be analyzed across brain lobes.

Results and safety

Results posted to the registry on 7 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Then AOC	15	15
AOC Then Placebo	9	9

Primary outcome: Cerebral Blood Flow in Normoxia, Male vs Female

Time frame: up to 6 months. Mean (Standard Deviation). Unit: mL/100g/min

Measure	Male Antioxidant Cocktail n = 11	Male Placebo n = 11	Female Antioxidant Cocktail n = 8	Female Placebo n = 8
Value	34 (7)	30 (7)	45 (10)	43 (7)

Population analysed: All 19 participants completed both conditions (placebo and antioxidant) under baseline conditions. Analyses were performed on 18 participants (11 males, 8 females), as one participant's brain imaging data were not accessible at the time of this report.

Primary outcome: Cerebral Blood Flow in Hyperoxia, Male vs Female

Time frame: up to 6 months. Mean (Standard Deviation). Unit: mL/100g/min

Measure	Male Antioxidant Cocktail n = 11	Male Placebo n = 11	Female Antioxidant Cocktail n = 8	Female Placebo n = 8
Value	30 (4)	30 (4)	45 (11)	42 (9)

Population analysed: All participants completed both conditions (placebo and antioxidant) under hyperoxia conditions. Analyses were performed on 19 participants (11 males, 8 females), as one participant's brain imaging data were not accessible at the time of this report.

Primary outcome: Lobar Cerebral Blood Flow in Normoxia, Male vs Female

Time frame: up to 6 months. Mean (Standard Deviation). Unit: mL/100 g/min

Measure	Male Antioxidant Cocktail n = 10	Male Placebo n = 10	Female Antioxidant Cocktail n = 8	Female Placebo n = 8
Brain Stem / Cerebellum	24 (6)	20 (4)	26 (10)	27 (3)
Subcortical Regions	39 (5)	36 (8)	51 (11)	48 (10)
Frontal Lobe	48 (8)	44 (10)	67 (18)	63 (14)
Temporal Lobe	35 (6)	32 (7)	48 (11)	44 (11)
Parietal Lobe	32 (5)	30 (6)	48 (13)	45 (8)
Occipital Lobe	23 (5)	20 (5)	35 (9)	33 (7)

Population analysed: Primary goal of this study was to compare male vs female changes in the brain, the crossover model was used to mitigate confounding factors related to the conditions.

Primary outcome: Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female

Time frame: up to 6 months. Mean (Standard Deviation). Unit: mL/100 g/min

Measure	Male Antioxidant Cocktail n = 9	Male Placebo n = 9	Female Antioxidant Cocktail n = 8	Female Placebo n = 8
Brain Stem / Cerebellum	25 (9)	22 (5)	29 (9)	28 (11)
Subcortical Regions	35 (6)	33 (7)	52 (12)	48 (7)
Frontal Lobe	44 (9)	42 (10)	66 (17)	61 (14)
Temporal Lobe	32 (6)	31 (7)	45 (11)	43 (9)
Parietal Lobe	28 (5)	27 (6)	45 (14)	41 (8)
Occipital Lobe	21 (5)	19 (2)	33 (9)	32 (7)

Population analysed: Primary goal of this study was to compare male vs female changes in the brain, the crossover model was used to mitigate confounding factors related to the conditions.

Adverse events

Time frame: data collected at screening and 2, 1-hour study visits over approximately 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Male Participants - Placebo	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Male Participants - AOC	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Female Participants - Placebo	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Female Participants - AOC	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Human Cerebral Blood Flow Regulation (Gas Challenge)Link provided by the sponsor.
Brain Blood Flow Responses to Stress: Sex DifferencesLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William G Schrage, PhD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Antioxidant Cocktail in people with Cerebrovascular Disorders, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebral Blood Flow in Normoxia, Male vs Female (time frame: up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05958303.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.