Bioavailability Heathy Volunteers, Safety
Conditions
Keywords
pharmacokinetics, glutathione, bioavailability, safety, micellar delivery system
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTLiposomal Glutathione
A maximum single dose of 300 mg glutathione (hard gel capsules)
DIETARY_SUPPLEMENTStandard Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
DIETARY_SUPPLEMENTNew Micellar Glutathione (Lipomicel)
A maximum single dose of 300 mg glutathione (soft gel capsules)
Sponsors
Factors Group of Nutritional Companies Inc.
Isura
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC: the area under the concentration-time curve | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aspartate aminotransferase (AST) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in liver function based on AST. |
| Alkaline phosphatase (ALP) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in liver function based on ALP. |
| Bilirubin | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in liver function based on Bilirubin. |
| Serum creatinine | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in kidney function based on Serum creatinine. |
| Blood urea nitrogen (BUN) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in kidney function based on BUN. |
| Glomerular filtration rate (GFR) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in kidney function based on GFR. |
| C-reactive protein (CRP) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in inflammatory response based on CRP. |
| White blood cell count (WBC) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in complete blood count based on WBC. |
| Hemoglobin (Hb) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in complete blood count based on Hb. |
| Fasting blood glucose | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in blood glucose levels based on fasting blood glucose. |
| Total cholesterol | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in lipid profile based on total cholesterol. |
| Low-density lipoprotein (LDL) cholesterol | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in lipid profile based on LDL. |
| High-density lipoprotein (HDL) cholesterol | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in lipid profile based on HDL. |
| Hematocrit (Hct) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in complete blood count based on Hct. |
| Triglycerides | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in lipid profile based on triglycerides. |
| Platelet count | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in complete blood count based on Platelet count. . |
| Alanine aminotransferase (ALT) | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | To evaluate changes in liver function based on ALT. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORJulia Solnier, PhD
Isura
Outcome results
None listed