Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

Factors Group of Nutritional Companies

Status: Completed

Conditions: Bioavailability; Safety

Treatments: Dietary Supplement: Standard Glutathione; Dietary Supplement: Liposomal Glutathione; Dietary Supplement: New Micellar Glutathione (Lipomicel)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06345950

2022-04-003

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 3 patient groups

Liposomal Glutathione

Experimental group

Description:

Each participant receives their treatment i.e., Liposomal Glutathione hard gel capsules at a total dose of 500 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 14 days between each treatment is used.

Treatment:

Dietary Supplement: Liposomal Glutathione

Standard Glutathione

Experimental group

Description:

Each participant receives their treatment i.e., Standard Glutathione hard gel capsules at a total dose of 500 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 14 days between each treatment is used.

Treatment:

Dietary Supplement: Standard Glutathione

New Micellar Glutathione (Lipomicel)

Experimental group

Description:

Each participant receives their treatment i.e., LipoMicel Glutathione soft gel capsules at a total dose of 600 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of at least 14 days between each treatment is used.

Treatment:

Dietary Supplement: New Micellar Glutathione (Lipomicel)