Trial Outcomes & Findings for HYPEROXIA Responses and ROS (NCT NCT05958303)
NCT ID: NCT05958303
Last Updated: 2026-07-07
Results Overview
Participants will be randomized to AOC or placebo. Normoxia measures will be collected under each condition in the MRI over 2 study visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
up to 6 months
Results posted on
2026-07-07
Participant Flow
24 participants were identified and recruited from participants who had completed the NCT04265053 MRI study or from the general population. Anyone from the general population had to complete the NCT04265053 study prior to enrollment in this study.
No pre-assignment details to report.
Participant milestones
| Measure |
Placebo Then AOC
Randomized to MRI visit involving either placebo or antioxidant cocktail first.
Antioxidant Cocktail: MRI visit involves dose of 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 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
AOC Then Placebo
Randomized to MRI visit involving either placebo or antioxidant cocktail first.
Antioxidant Cocktail: MRI visit involves dose of 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 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
|---|---|---|
|
FIrst Condition
STARTED
|
15
|
9
|
|
FIrst Condition
Male Participants in Analysis Population
|
7
|
4
|
|
FIrst Condition
Female Participants in Analysis Population
|
5
|
3
|
|
FIrst Condition
COMPLETED
|
15
|
9
|
|
FIrst Condition
NOT COMPLETED
|
0
|
0
|
|
Washout Period (24 Hours)
STARTED
|
15
|
9
|
|
Washout Period (24 Hours)
COMPLETED
|
14
|
8
|
|
Washout Period (24 Hours)
NOT COMPLETED
|
1
|
1
|
|
Second Condition
STARTED
|
14
|
8
|
|
Second Condition
Male Participants in Analysis Population
|
7
|
4
|
|
Second Condition
Female Participants in Analysis Population
|
5
|
3
|
|
Second Condition
COMPLETED
|
14
|
8
|
|
Second Condition
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Then AOC
Randomized to MRI visit involving either placebo or antioxidant cocktail first.
Antioxidant Cocktail: MRI visit involves dose of 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 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
AOC Then Placebo
Randomized to MRI visit involving either placebo or antioxidant cocktail first.
Antioxidant Cocktail: MRI visit involves dose of 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 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
|---|---|---|
|
Washout Period (24 Hours)
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
HYPEROXIA Responses and ROS
Baseline characteristics by cohort
| Measure |
Male Participants
n=11 Participants
Randomized to MRI visit involving either placebo or antioxidant cocktail first.
Antioxidant Cocktail: MRI visit involves dose of 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 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Female Participants
n=8 Participants
Randomized to MRI visit involving either placebo or antioxidant cocktail first.
Antioxidant Cocktail: MRI visit involves dose of 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 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.8 Years
n=20 Participants
|
22.9 Years
n=20 Participants
|
22.3 Years
n=40 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: 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.
Participants will be randomized to AOC or placebo. Normoxia measures will be collected under each condition in the MRI over 2 study visits.
Outcome measures
| Measure |
Female Placebo
n=8 Participants
MRI visit involves placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Male Antioxidant Cocktail
n=11 Participants
MRI visit involves dose of 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.
|
Male Placebo
n=11 Participants
MRI visit involves placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Female Antioxidant Cocktail
n=8 Participants
MRI visit involves dose of 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.
|
|---|---|---|---|---|
|
Cerebral Blood Flow in Normoxia, Male vs Female
|
43 mL/100g/min
Standard Deviation 7
|
34 mL/100g/min
Standard Deviation 7
|
30 mL/100g/min
Standard Deviation 7
|
45 mL/100g/min
Standard Deviation 10
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: 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.
Participants will be randomized to AOC or placebo. Hyperoxia measures will be collected under each condition in the MRI over 2 study visits.
Outcome measures
| Measure |
Female Placebo
n=8 Participants
MRI visit involves placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Male Antioxidant Cocktail
n=11 Participants
MRI visit involves dose of 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.
|
Male Placebo
n=11 Participants
MRI visit involves placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Female Antioxidant Cocktail
n=8 Participants
MRI visit involves dose of 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.
|
|---|---|---|---|---|
|
Cerebral Blood Flow in Hyperoxia, Male vs Female
|
42 mL/100g/min
Standard Deviation 9
|
30 mL/100g/min
Standard Deviation 4
|
30 mL/100g/min
Standard Deviation 4
|
45 mL/100g/min
Standard Deviation 11
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Female Placebo
n=8 Participants
MRI visit involves placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Male Antioxidant Cocktail
n=10 Participants
MRI visit involves dose of 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.
|
Male Placebo
n=10 Participants
MRI visit involves placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Female Antioxidant Cocktail
n=8 Participants
MRI visit involves dose of 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.
|
|---|---|---|---|---|
|
Lobar Cerebral Blood Flow in Normoxia, Male vs Female
Subcortical Regions
|
48 mL/100 g/min
Standard Deviation 10
|
39 mL/100 g/min
Standard Deviation 5
|
36 mL/100 g/min
Standard Deviation 8
|
51 mL/100 g/min
Standard Deviation 11
|
|
Lobar Cerebral Blood Flow in Normoxia, Male vs Female
Brain Stem / Cerebellum
|
27 mL/100 g/min
Standard Deviation 3
|
24 mL/100 g/min
Standard Deviation 6
|
20 mL/100 g/min
Standard Deviation 4
|
26 mL/100 g/min
Standard Deviation 10
|
|
Lobar Cerebral Blood Flow in Normoxia, Male vs Female
Frontal Lobe
|
63 mL/100 g/min
Standard Deviation 14
|
48 mL/100 g/min
Standard Deviation 8
|
44 mL/100 g/min
Standard Deviation 10
|
67 mL/100 g/min
Standard Deviation 18
|
|
Lobar Cerebral Blood Flow in Normoxia, Male vs Female
Temporal Lobe
|
44 mL/100 g/min
Standard Deviation 11
|
35 mL/100 g/min
Standard Deviation 6
|
32 mL/100 g/min
Standard Deviation 7
|
48 mL/100 g/min
Standard Deviation 11
|
|
Lobar Cerebral Blood Flow in Normoxia, Male vs Female
Parietal Lobe
|
45 mL/100 g/min
Standard Deviation 8
|
32 mL/100 g/min
Standard Deviation 5
|
30 mL/100 g/min
Standard Deviation 6
|
48 mL/100 g/min
Standard Deviation 13
|
|
Lobar Cerebral Blood Flow in Normoxia, Male vs Female
Occipital Lobe
|
33 mL/100 g/min
Standard Deviation 7
|
23 mL/100 g/min
Standard Deviation 5
|
20 mL/100 g/min
Standard Deviation 5
|
35 mL/100 g/min
Standard Deviation 9
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Female Placebo
n=8 Participants
MRI visit involves placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Male Antioxidant Cocktail
n=9 Participants
MRI visit involves dose of 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.
|
Male Placebo
n=9 Participants
MRI visit involves placebo 120 minutes before MRI, followed by another dose of placebo 60 minutes before MRI.
|
Female Antioxidant Cocktail
n=8 Participants
MRI visit involves dose of 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.
|
|---|---|---|---|---|
|
Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female
Brain Stem / Cerebellum
|
28 mL/100 g/min
Standard Deviation 11
|
25 mL/100 g/min
Standard Deviation 9
|
22 mL/100 g/min
Standard Deviation 5
|
29 mL/100 g/min
Standard Deviation 9
|
|
Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female
Subcortical Regions
|
48 mL/100 g/min
Standard Deviation 7
|
35 mL/100 g/min
Standard Deviation 6
|
33 mL/100 g/min
Standard Deviation 7
|
52 mL/100 g/min
Standard Deviation 12
|
|
Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female
Temporal Lobe
|
43 mL/100 g/min
Standard Deviation 9
|
32 mL/100 g/min
Standard Deviation 6
|
31 mL/100 g/min
Standard Deviation 7
|
45 mL/100 g/min
Standard Deviation 11
|
|
Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female
Parietal Lobe
|
41 mL/100 g/min
Standard Deviation 8
|
28 mL/100 g/min
Standard Deviation 5
|
27 mL/100 g/min
Standard Deviation 6
|
45 mL/100 g/min
Standard Deviation 14
|
|
Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female
Occipital Lobe
|
32 mL/100 g/min
Standard Deviation 7
|
21 mL/100 g/min
Standard Deviation 5
|
19 mL/100 g/min
Standard Deviation 2
|
33 mL/100 g/min
Standard Deviation 9
|
|
Lobar Cerebral Blood Flow in Hyperoxia, Male vs Female
Frontal Lobe
|
61 mL/100 g/min
Standard Deviation 14
|
44 mL/100 g/min
Standard Deviation 9
|
42 mL/100 g/min
Standard Deviation 10
|
66 mL/100 g/min
Standard Deviation 17
|
Adverse Events
Male Participants - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Male Participants - AOC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Female Participants - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Female Participants - AOC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Male Participants - Placebo
n=11 participants at risk
Male Participants in analysis population
|
Male Participants - AOC
n=11 participants at risk
Male Participants in analysis population
|
Female Participants - Placebo
n=8 participants at risk
Female Participants in analysis population
|
Female Participants - AOC
n=8 participants at risk
Female Participants in analysis population
|
|---|---|---|---|---|
|
General disorders
Syncope
|
0.00%
0/11 • data collected at screening and 2, 1-hour study visits over approximately 6 months
|
9.1%
1/11 • data collected at screening and 2, 1-hour study visits over approximately 6 months
|
0.00%
0/8 • data collected at screening and 2, 1-hour study visits over approximately 6 months
|
0.00%
0/8 • data collected at screening and 2, 1-hour study visits over approximately 6 months
|
Additional Information
William Schrage, PhD
University of Wisconsin - Madison
Phone: (608) 262-7715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place