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| Name | Class |
|---|---|
| Isura | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Glutathione | Dietary Supplement | A maximum single dose of 300 mg glutathione (hard gel capsules) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine aminotransferase (ALT) | To evaluate changes in liver function based on ALT. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Aspartate aminotransferase (AST) | To evaluate changes in liver function based on AST. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Solnier, PhD | Isura | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISURA | Burnaby | British Columbia | V2N 4S9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41897500 | Derived | 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. |
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| ID | Term |
|---|---|
| C000591311 | glutathione pegylated liposomal doxorubicin |
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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.
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| Standard Glutathione | Dietary Supplement | A maximum single dose of 500 mg glutathione (hard gel capsules) |
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| New Micellar Glutathione (Lipomicel) | Dietary Supplement | A maximum single dose of 300 mg glutathione (soft gel capsules) |
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| 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Alkaline phosphatase (ALP) | To evaluate changes in liver function based on ALP. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Bilirubin | To evaluate changes in liver function based on Bilirubin. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Serum creatinine | 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) | To evaluate changes in kidney function based on BUN. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Glomerular filtration rate (GFR) | To evaluate changes in kidney function based on GFR. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| C-reactive protein (CRP) | 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) | To evaluate changes in complete blood count based on WBC. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Hemoglobin (Hb) | To evaluate changes in complete blood count based on Hb. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Hematocrit (Hct) | To evaluate changes in complete blood count based on Hct. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Platelet count | 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 | 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 | 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 | 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 | To evaluate changes in lipid profile based on HDL. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
| Triglycerides | To evaluate changes in lipid profile based on triglycerides. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |