Clinical trial NCT05926245: Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection
Official title: Topical Absorption of Glutathione-cyclodextrin Complex in Healthy Human Subjects Improves Immune Response Against Mycobacterium Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glutathione-cyclodextrin Complex Absorption
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* Group 1 (Control group) will include 15 healthy volunteers with the age group between 21-65. Participants belonging to Group 1 will be recruited from the local area. Group 1 will serve as controls for Group 2.

Group 2 (Glutathione Group) will include 15 healthy volunteers that are not allergic to any components of GlutarylTM who will be sprayed four times twice a day for three days with Topical glutathione Complex (GlutarylTM) formulation on their skin on their ventral part of the abdomen.

Components of Glutaryl:

Main ingredients of Glutaryl are Glutathione, ascorbic acid and cyclodextrin. The preservative system used is potassium sorbate and radish root extracts.

Exclusion Criteria:

* Pregnant and breastfeeding women. Anyone below age of 21 or above age of 65. Patients with active cancer. Patients with known liver disease, hepatitis, COVD-19, HIV, or AIDS. Patients taking some form of glutathione. Subjects who have previously fainted following venipuncture will also be excluded. By interviewing the subjects we will determine whether or not the subject will be excluded from the study based on their previous phlebotomy experiences.

Primary outcomes:
measure: GSH
timeFrame: 72 hours
Secondary outcomes:
measure: Free Radicals
timeFrame: 72 hours
measure: Pro- and Anti-inflammatory Cytokines
timeFrame: 72 hours
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
Study officials:
affiliation: Western University of Health Sciences
name: Cesar Ochoa, MD
role: STUDY_DIRECTOR
References: