Skip to main content
OpenTrials
Completed

NCT Number: NCT01967667

Biological Evaluation of Dietary Supplement Liposomal 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. In this study we will evaluate a liposomal formulation of glutathione for tolerability and to examine if this formulation serves the function of increasing glutathione in the brain and body.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

About this study

Additional information about this dietary supplement:

  • Glutathione is an antioxidant naturally produced in our body. Glutathione protects the brain and other organs from oxidative stress.
  • Low glutathione is associated with high oxidative stress, which has been linked to aging and many illnesses. 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 our gut.
  • Scientists have now found a way to wrap glutathione in tiny drops of oil particles called liposomes. That way, the gut cannot break it down so it is absorbed into our body. Once inside the body, our cells can take in the liposomes and use the glutathione to reduce oxidative stress.
  • Liposome-wrapped glutathione is not a drug or medicine.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Clinically stable with no change in antipsychotic medications nor significant increase of daily dose for 2 weeks prior to enrollment
  • Low baseline blood glutathione level (GSH < 890 umol/l)

Exclusion criteria

  • History of major medical illness including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)
  • History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration
  • 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)
  • On medication containing cholesterol absorption inhibitor such as ezetimibe (Brand names Zetia, Ezetrol, Vytorin, and Inegy)
  • Women who have positive urine pregnancy tests
  • Women who plan to become pregnant, or are breastfeeding
  • Unable to undergo MRI scanning due to metallic devices or objects or claustrophobia
  • Already taking dietary antioxidant supplements such as n-acetylcysteine or fish oil on regular basis (more than twice a week) in the last 3 months
  • History of allergy to soy or soy products
  • Hyperlipidemia (baseline LDL > 1.5 x upper limit of normal)
  • Liver impairment (baseline AST or ALT > 2.0 x upper limit of normal)

Treatment and study plan

Liposomal Glutathione

Dietary Supplement

Escalating dose steps

Other names: ReadiSorb glutathione

Placebo

Dietary Supplement

escalating dose steps

Other names: Readisorb solution without glutathione

Primary outcomes

  1. Glutathione levels

    Time frame: Baseline and 3 weeks

    Change of glutathione levels from baseline to following 3 weeks of treatment.

Secondary outcomes

  1. oxidative stress biomarker

    Time frame: baseline and 3 weeks

    blood levels of lipid peroxidation

  2. inflammatory marker

    Time frame: baseline and 3 weeks

    Blood levels of cytokines as biomarkers of inflammation

Other outcomes

  1. BPRS

    Time frame: Baseline and 3 weeks

    Change in brief psychiatric rating scale scores from baseline to end of treatment phase and end of placebo phase.

  2. Adverse events

    Time frame: Baseline and 3 weeks

    side-effects checklist

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2013
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.