Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

Safety Clinical Trial

Official title:

Pharmacokinetics and Safety of a New Micellar Glutathione Formulation in Human Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06345950
• Other study ID #: 2022-04-003
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2024
• Source: Factors Group of Nutritional Companies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bioavailability
• Safety

Intervention

Dietary Supplement:
• Liposomal Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
• Standard Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
• New Micellar Glutathione (Lipomicel)
A maximum single dose of 600 mg glutathione (soft gel capsules)

Locations

Country	Name	City	State
Canada	ISURA	Burnaby	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Factors Group of Nutritional Companies Inc.	Isura

Country where clinical trial is conducted

Canada, 

Outcome

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)