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

NCT05926245 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-03

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Glutaryl Solution

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

DIETARY_SUPPLEMENT

Placebo Solution

Empty nanoparticles

Sponsors & Collaborators

  • Western University of Health Sciences

    lead OTHER

Principal Investigators

  • Cesar Ochoa, MD · Western University of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2022-08-02
Completion
2022-12-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926245 on ClinicalTrials.gov