NCT05926245

Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Western University of Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glutathione-cyclodextrin Complex Absorption

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Glutaryl Solution	Glutathione, ascorbic acid, cyclodextrin, potassium sorbate and radish root extracts
DIETARY_SUPPLEMENT	Placebo Solution	Empty nanoparticles

Timeline

• Start date: 2022-07-11
• Primary completion: 2022-08-02
• Completion: 2022-12-14
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: United States