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

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.

Study Overview

• Status: Completed
• Conditions: Glutathione-cyclodextrin Complex Absorption
• Intervention / Treatment: Dietary supplement: Placebo Solution; Dietary supplement: Glutaryl Solution

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Pomona, California, United States, 91766
      • Western University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; 15 adult healthy volunteers to serve as controls for the experimental group. This group will receive a placebo-topical spray with empty nanoparticles.	Dietary supplement: Placebo Solution; Empty nanoparticles
Experimental: Glutathione Group; 15 adult healthy volunteers will serve in the experimental group. This group will receive glutaryl treatment topical spray with nanoparticles containing GSH.	Dietary supplement: Glutaryl Solution; Glutathione, ascorbic acid, cyclodextrin, potassium sorbate and radish root extracts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GSH	Levels of total, reduced, and oxidized forms of GSH in the isolated plasma, red blood cells (RBCs) and peripheral blood mononuclear cells (PBMCs) isolated from the peripheral blood of the two-study groups will be assayed by spectrophotometry using an assay kit from Arbor Assays (3-12).	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free Radicals	To demonstrate that increased levels of GSH in the experimental group is accompanied by decreased levels of reactive oxygen species (ROS), free radical activity will be measured by malondialdehyde (MDA) assay that measures several end products of lipid peroxidation (3-12).	72 hours
Pro- and Anti-inflammatory Cytokines	To demonstrate that increased levels of GSH in the experimental group is accompanied by altered levels of pro- and anti-inflammatory cytokines and chemokines, we will measure the levels of pro- and anti-inflammatory cytokines and cytokines in the plasma derived from the two study groups by ELISA using an assay kit from ThermoFisher.	72 hours

Collaborators and Investigators

• Sponsor: Western University of Health Sciences
• Investigators: Study Director: Cesar Ochoa, MD, Western University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: June 17, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Pharmaceutical Solutions
• Other Study ID Numbers: antioxidants-2402271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No