Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

What Was Tested

This registered not phased trial tested Glutathione.

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 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.

It had three arms (groups): Liposomal Glutathione (experimental), Standard Glutathione (experimental) and New Micellar Glutathione (Lipomicel) (experimental).

The registry classes the interventions as dietary supplement.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female aged 21-65 years. Healthy, good physical condition. Voluntary, written, informed consent to participate in the study.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Glutathione study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Glutathione and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2022-06-21 with completion listed for 2025-06-30.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUC: the area under the concentration-time curve. Cmax: maximum plasma concentration. Tmax: the time point of maximum plasma concentration.

It also tracked 17 secondary outcomes, for example Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), Bilirubin, Serum creatinine and Blood urea nitrogen (BUN).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.