Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926245
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2023-06-17
Brief Title:
Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection
Sponsor:
Western University of Health Sciences
Organization:
Western University of Health Sciences
Study Overview
Official Title:
Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed clinical trial will confirm the therapeutic absorption of glutathione following topical Glutaryl application in increasing blood GSH levels without an invasive procedure
GOAL Confirm therapeutic level of glutathione following topical transdermal application
HYPOTHESIS The hypothesis of the proposed study is that the glutathione administration will increase RBC levels of glutathione above 80
AIM Determine a non-invasive way to increase glutathione levels in the plasma and blood cells
This aim will be accomplished as follows
STEP 1 We will recruit eligible healthy participants in the two study groups who are not currently taking any glutathione or N-acetyl cysteine NAC supplementation
STEP 2 Determine baseline levels of GSH free radicals and cytokines through analysis of venipuncture blood draws
STEP 3 Study subjects will be asked to spray themselves with either placebo or Glutaryl four times twice a day for three days on the ventral part of the abdomen Measure the levels of GSH free radicals and cytokines after 1 hour 4 hour and 72 hours
GOAL Confirm therapeutic level of glutathione following topical transdermal application
HYPOTHESIS The hypothesis of the proposed study is that the glutathione administration will increase RBC levels of glutathione above 80
AIM Determine a non-invasive way to increase glutathione levels in the plasma and blood cells
This aim will be accomplished as follows
STEP 1 We will recruit eligible healthy participants in the two study groups who are not currently taking any glutathione or N-acetyl cysteine NAC supplementation
STEP 2 Determine baseline levels of GSH free radicals and cytokines through analysis of venipuncture blood draws
STEP 3 Study subjects will be asked to spray themselves with either placebo or Glutaryl four times twice a day for three days on the ventral part of the abdomen Measure the levels of GSH free radicals and cytokines after 1 hour 4 hour and 72 hours
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None