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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Glutaryl Solution

Placebo Solution

About this trial

This is an interventional basic science trial for Glutathione-cyclodextrin Complex Absorption

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Western University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

Glutathione Group

Arm Description

15 adult healthy volunteers to serve as controls for the experimental group. This group will receive a placebo-topical spray with empty nanoparticles.

15 adult healthy volunteers will serve in the experimental group. This group will receive glutaryl treatment topical spray with nanoparticles containing GSH.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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.

Full Information

NCT ID

NCT05926245

First Posted

June 17, 2023

Last Updated

June 26, 2023

Sponsor

Western University of Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05926245

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

July 11, 2022 (Actual)

Primary Completion Date

August 2, 2022 (Actual)

Study Completion Date

December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Western University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glutathione-cyclodextrin Complex Absorption

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

15 adult healthy volunteers to serve as controls for the experimental group. This group will receive a placebo-topical spray with empty nanoparticles.

Arm Title

Glutathione Group

Arm Type

Experimental

Arm Description

15 adult healthy volunteers will serve in the experimental group. This group will receive glutaryl treatment topical spray with nanoparticles containing GSH.

Intervention Type

Dietary Supplement

Intervention Name(s)

Glutaryl Solution

Intervention Description

Glutathione, ascorbic acid, cyclodextrin, potassium sorbate and radish root extracts

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Solution

Intervention Description

Empty nanoparticles

Primary Outcome Measure Information:

Title

GSH

Description

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).

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Free Radicals

Description

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).

Time Frame

72 hours

Title

Pro- and Anti-inflammatory Cytokines

Description

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.

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cesar Ochoa, MD

Organizational Affiliation

Western University of Health Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Western University of Health Sciences

City

Pomona

State/Province

California

ZIP/Postal Code

91766

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Glutathione-cyclodextrin Complex Absorption

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial