Pharmacokinetics and Safety of a New Micellar Glutathione Formulation
- Conditions
- BioavailabilitySafety
- Registration Number
- NCT06345950
- Lead Sponsor
- Factors Group of Nutritional Companies Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- male or female aged 21-65 years
- healthy, good physical condition
- voluntary, written, informed consent to participate in the study.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method Serum creatinine 0 (baseline; pre-dose), week 2 and week 4 (post-dose) To evaluate changes in kidney function based on Serum creatinine.
Platelet count 0 (baseline; pre-dose), week 2 and week 4 (post-dose) To evaluate changes in complete blood count based on Platelet count.
.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.
Triglycerides 0 (baseline; pre-dose), week 2 and week 4 (post-dose) To evaluate changes in lipid profile based on triglycerides.
Alanine aminotransferase (ALT) 0 (baseline; pre-dose), week 2 and week 4 (post-dose) To evaluate changes in liver function based on ALT.
Bilirubin 0 (baseline; pre-dose), week 2 and week 4 (post-dose) To evaluate changes in liver function based on Bilirubin.
C-reactive protein (CRP) 0 (baseline; pre-dose), week 2 and week 4 (post-dose) To evaluate changes in inflammatory response based on CRP.
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.
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.
Hemoglobin (Hb) 0 (baseline; pre-dose), week 2 and week 4 (post-dose) To evaluate changes in complete blood count based on Hb.
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.
Hematocrit (Hct) 0 (baseline; pre-dose), week 2 and week 4 (post-dose) To evaluate changes in complete blood count based on Hct.
Total cholesterol 0 (baseline; pre-dose), week 2 and week 4 (post-dose) To evaluate changes in lipid profile based on total cholesterol.
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.
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.
Trial Locations
- Locations (1)
ISURA
🇨🇦Burnaby, British Columbia, Canada
ISURA🇨🇦Burnaby, British Columbia, Canada