Biological Evaluation of Dietary Supplement Liposomal Glutathione

What Was Tested

In this not phased trial, researchers set out to test Glutathione.

Low levels of antioxidant molecules such as glutathione have been found in people with a diagnosis of schizophrenia.

However, oral glutathione is not well absorbed because the compound is mostly broken down in the gastrointestinal system.

Liposomes are tiny droplets of oil particles that encapsulate and protect the glutathione.

It had two arms (groups): Liposomal glutathione (experimental) and Placebo (placebo comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

Additional information about this dietary supplement: * Glutathione is an antioxidant naturally produced in their body.

Schizophrenia is a mental illness that doctors still do not fully understand.

Individuals with schizophrenia often have low levels of glutathione. * Glutathione can be supplied through dietary supplement.

However, if taken plainly, it easily breaks down in their gut. * Scientists have now found a way to wrap glutathione in tiny drops of oil particles called liposomes.

Who Took Part

The registry lists 11 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age range: 18-60. DSM diagnosis of schizophrenia spectrum disorder, including schizophrenia, schizoaffective disorder, and schizophreniform disorder. Ability to give written informed consent (Evaluation to Sign Consent score 10 or greater). Low baseline blood glutathione level (GSH \< 890 umol/l).

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: history of major medical illness including, but not limited to, history of heart attack, stroke, tia (transient ischemic attack); DSM diagnosis of substance dependence within 6 months except nicotine and marijuana, or substance abuse in past month; uncontrolled blood pressure (persistent systolic above 165 or diastolic above 100).

How the Study Was Run

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

The participants were allocated by chance, so the Glutathione group and the comparison group should start out alike.

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, care provider, investigator and outcomes assessor.

It started in 2014-04 with completion listed for 2021-02.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Glutathione levels (time frame: Baseline and 3 weeks).

It also tracked 2 secondary outcomes, for example oxidative stress biomarker and inflammatory marker.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 11 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.