Safety Clinical Trial
Official title:
Pharmacokinetics and Safety of a New Micellar Glutathione Formulation in Human Participants
NCT number | NCT06345950 |
Other study ID # | 2022-04-003 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 21, 2022 |
Est. completion date | June 30, 2023 |
Verified date | March 2024 |
Source | Factors Group of Nutritional Companies Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | June 30, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | ISURA | Burnaby | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Factors Group of Nutritional Companies Inc. | Isura |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Secondary | Alanine aminotransferase (ALT) | To evaluate changes in liver function based on ALT. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | Aspartate aminotransferase (AST) | To evaluate changes in liver function based on AST. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | Alkaline phosphatase (ALP) | To evaluate changes in liver function based on ALP. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | Bilirubin | To evaluate changes in liver function based on Bilirubin. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | Serum creatinine | To evaluate changes in kidney function based on Serum creatinine. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | Blood urea nitrogen (BUN) | To evaluate changes in kidney function based on BUN. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | Glomerular filtration rate (GFR) | To evaluate changes in kidney function based on GFR. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | C-reactive protein (CRP) | To evaluate changes in inflammatory response based on CRP. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | 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) | |
Secondary | Hemoglobin (Hb) | To evaluate changes in complete blood count based on Hb. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | Hematocrit (Hct) | To evaluate changes in complete blood count based on Hct. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | Platelet count | To evaluate changes in complete blood count based on Platelet count.
. |
0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | 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) | |
Secondary | Total cholesterol | To evaluate changes in lipid profile based on total cholesterol. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | Triglycerides | To evaluate changes in lipid profile based on triglycerides. | 0 (baseline; pre-dose), week 2 and week 4 (post-dose) |
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