Bioavailability Heathy VolunteersNCT06345950
Pharmacokinetics and Safety of a New Micellar Glutathione Formulation
A study testing Liposomal Glutathione, Standard Glutathione and New Micellar Glutathione (Lipomicel) in people with Bioavailability Heathy Volunteers and Safety, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability Heathy Volunteers, Safety
- What is being tested?
- Liposomal Glutathione, Standard Glutathione and New Micellar Glutathione (Lipomicel)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jun 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female aged 21-65 years
- healthy, good physical condition
- voluntary, written, informed consent to participate in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bioavailability Heathy Volunteers, Safety
- Being tested
- Liposomal Glutathione, Standard Glutathione, New Micellar Glutathione (Lipomicel)
- Keywords
- pharmacokinetics, glutathione, bioavailability, safety, micellar delivery system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal GlutathioneDietary supplement
A maximum single dose of 300 mg glutathione (hard gel capsules)
Standard GlutathioneDietary supplement
A maximum single dose of 500 mg glutathione (hard gel capsules)
New Micellar Glutathione (Lipomicel)Dietary supplement
A maximum single dose of 300 mg glutathione (soft gel capsules)
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Glutathione | Experimental | 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. Receives: Dietary Supplement: Liposomal Glutathione |
| Standard Glutathione | Experimental | 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. Receives: Dietary Supplement: Standard Glutathione |
| New Micellar Glutathione (Lipomicel) | Experimental | 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. Receives: Dietary Supplement: New Micellar Glutathione (Lipomicel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC: the area under the concentration-time curve
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.
Measured: 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
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.
Measured: 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
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.
Measured: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
Secondary outcomes (17)
Alanine aminotransferase (ALT)
To evaluate changes in liver function based on ALT.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Aspartate aminotransferase (AST)
To evaluate changes in liver function based on AST.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Alkaline phosphatase (ALP)
To evaluate changes in liver function based on ALP.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Bilirubin
To evaluate changes in liver function based on Bilirubin.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Serum creatinine
To evaluate changes in kidney function based on Serum creatinine.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Blood urea nitrogen (BUN)
To evaluate changes in kidney function based on BUN.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Glomerular filtration rate (GFR)
To evaluate changes in kidney function based on GFR.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
C-reactive protein (CRP)
To evaluate changes in inflammatory response based on CRP.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
White blood cell count (WBC)
To evaluate changes in complete blood count based on WBC.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Hemoglobin (Hb)
To evaluate changes in complete blood count based on Hb.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Hematocrit (Hct)
To evaluate changes in complete blood count based on Hct.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Platelet count
To evaluate changes in complete blood count based on Platelet count.
.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Fasting blood glucose
To evaluate changes in blood glucose levels based on fasting blood glucose.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Total cholesterol
To evaluate changes in lipid profile based on total cholesterol.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Low-density lipoprotein (LDL) cholesterol
To evaluate changes in lipid profile based on LDL.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
High-density lipoprotein (HDL) cholesterol
To evaluate changes in lipid profile based on HDL.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Triglycerides
To evaluate changes in lipid profile based on triglycerides.
Measured: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start21 Jun 2022
- Primary completion30 Jun 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bioavailability Heathy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of one intervention with higher bioavailability is evaluated in an additional single-arm, 30-day trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Factors Group of Nutritional Companies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Isura
- Responsible party
- Sponsor
- Investigators
- Julia Solnier, PhD, Principal investigator, Isura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345950
- Sponsor's protocol ID
- 2022-04-003
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Solnier J, Du M, Zhang Y, Roh YS, Kuo YC, Ibi A, Wood S, Hardy M, Gahler RJ, Chang C. A Targeted Metabolomic Assessment of Oral Glutathione Bioavailability and Safety in Humans: A Randomized Crossover Clinical Trial. Antioxidants (Basel). 2026 Mar 11;15(3):354. doi: 10.3390/antiox15030354.
PubMed 41897500
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of a New Micellar Glutathione Formulation in Human Participants
- ClinicalTrials.gov ID
- NCT06345950
- Acronym / sponsor ID
- 2022-04-003
- Conditions
- Bioavailability Heathy Volunteers, Safety
- Keywords
- pharmacokinetics, glutathione, bioavailability, safety, micellar delivery system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Factors Group of Nutritional Companies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Isura
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of one intervention with higher bioavailability is evaluated in an additional single-arm, 30-day trial.
| Arm | Type | Receives |
|---|---|---|
| Liposomal Glutathione | Experimental | Dietary Supplement: Liposomal GlutathioneEach 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. |
| Standard Glutathione | Experimental | Dietary Supplement: Standard GlutathioneEach 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. |
| New Micellar Glutathione (Lipomicel) | Experimental | Dietary Supplement: 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female aged 21-65 years
- healthy, good physical condition
- voluntary, written, informed consent to participate in the study.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal GlutathioneA maximum single dose of 300 mg glutathione (hard gel capsules) | Dietary supplement | Liposomal Glutathione |
| Standard GlutathioneA maximum single dose of 500 mg glutathione (hard gel capsules) | Dietary supplement | Standard Glutathione |
| New Micellar Glutathione (Lipomicel)A maximum single dose of 300 mg glutathione (soft gel capsules) | Dietary supplement | New Micellar Glutathione (Lipomicel) |
Primary outcome
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.
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.
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.
17 secondary outcomes
Alanine aminotransferase (ALT)
Time frame: 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)
Alkaline phosphatase (ALP)
Time frame: 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)
Serum creatinine
Time frame: 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)
Glomerular filtration rate (GFR)
Time frame: 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)
White blood cell count (WBC)
Time frame: 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)
Hematocrit (Hct)
Time frame: 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)
Fasting blood glucose
Time frame: 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)
Low-density lipoprotein (LDL) cholesterol
Time frame: 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)
Triglycerides
Time frame: 0 (baseline; pre-dose), week 2 and week 4 (post-dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 41897500Solnier J, Du M, Zhang Y, Roh YS, Kuo YC, Ibi A, Wood S, Hardy M, Gahler RJ, Chang C. A Targeted Metabolomic Assessment of Oral Glutathione Bioavailability and Safety in Humans: A Randomized Crossover Clinical Trial. Antioxidants (Basel). 2026 Mar 11;15(3):354. doi: 10.3390/antiox15030354.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Solnier, PhD principal investigator
Isura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal Glutathione, Standard Glutathione and New Micellar Glutathione (Lipomicel) in people with Bioavailability Heathy Volunteers and Safety, run by Factors Group of Nutritional Companies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06345950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.