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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Factors Group of Nutritional Companies Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Isura

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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