Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

Factors Group of Nutritional Companies Inc.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bioavailability Heathy Volunteers Safety

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)