Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

February 24, 2026 updated by: Factors Group of Nutritional Companies Inc.

Pharmacokinetics and Safety of a New Micellar Glutathione Formulation in Human Participants

This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.

The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V2N 4S9
        • ISURA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • male or female aged 21-65 years
  • healthy, good physical condition
  • voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

  • use of anti-inflammatory or non-steroidal anti-inflammatory drugs
  • previous history of cardiovascular disease or acute or chronic inflammatory disease
  • use of antioxidant supplements or cholesterol-lowering agents
  • change of diet habits or lifestyle (diet, physical activity, etc.)
  • alcohol or substance abuse history
  • use of nicotine or tobacco
  • participation in another investigational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposomal Glutathione

Each participant receives their treatment i.e., Liposomal Glutathione hard gel capsules at a total dose of 300 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose.

A washout period of at least 1 week between each treatment is used.
Dietary supplement: Liposomal Glutathione
A maximum single dose of 300 mg glutathione (hard gel capsules)
Experimental: Standard Glutathione

Each participant receives their treatment i.e., Standard Glutathione hard gel capsules at a total dose of 500 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose.

A washout period of at least 1 week between each treatment is used.
Dietary supplement: Standard Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
Experimental: New Micellar Glutathione (Lipomicel)

Each participant receives their treatment i.e., LipoMicel Glutathione soft gel capsules at a total dose of 300 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose.

A washout period of at least 1 week between each treatment is used.
Dietary supplement: New Micellar Glutathione (Lipomicel)
A maximum single dose of 300 mg glutathione (soft gel capsules)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC: the area under the concentration-time curve
Time Frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested glutathione in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing glutathione.
0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
Cmax: maximum plasma concentration
Time Frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested glutathione in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing glutathione.
0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
Tmax: the time point of maximum plasma concentration
Time Frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested glutathione in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing glutathione.
0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alanine aminotransferase (ALT)
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in liver function based on ALT.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Aspartate aminotransferase (AST)
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in liver function based on AST.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Alkaline phosphatase (ALP)
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in liver function based on ALP.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Bilirubin
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in liver function based on Bilirubin.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Serum creatinine
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in kidney function based on Serum creatinine.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Blood urea nitrogen (BUN)
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in kidney function based on BUN.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Glomerular filtration rate (GFR)
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in kidney function based on GFR.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
C-reactive protein (CRP)
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in inflammatory response based on CRP.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
White blood cell count (WBC)
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in complete blood count based on WBC.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Hemoglobin (Hb)
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in complete blood count based on Hb.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Hematocrit (Hct)
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in complete blood count based on Hct.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Platelet count
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)

To evaluate changes in complete blood count based on Platelet count.

.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Fasting blood glucose
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in blood glucose levels based on fasting blood glucose.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Total cholesterol
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in lipid profile based on total cholesterol.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Low-density lipoprotein (LDL) cholesterol
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in lipid profile based on LDL.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
High-density lipoprotein (HDL) cholesterol
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in lipid profile based on HDL.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Triglycerides
Time Frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
To evaluate changes in lipid profile based on triglycerides.
0 (baseline; pre-dose), week 2 and week 4 (post-dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Factors Group of Nutritional Companies Inc.

Collaborators

Isura

Investigators

  • Principal Investigator: Julia Solnier, PhD, ISURA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2022

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-04-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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