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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Dietary supplement: Liposomal glutathione; Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • Maryland Psychiatric Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal glutathione; dose steps	Dietary supplement: Liposomal glutathione; Escalating dose steps; Other Names: ReadiSorb glutathione
Placebo Comparator: Placebo; dose steps	Dietary supplement: Placebo; escalating dose steps; Other Names: Readisorb solution without glutathione

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glutathione levels	Change of glutathione levels from baseline to following 3 weeks of treatment.	Baseline and 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxidative stress biomarker	blood levels of lipid peroxidation	baseline and 3 weeks
inflammatory marker	Blood levels of cytokines as biomarkers of inflammation	baseline and 3 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BPRS	Change in brief psychiatric rating scale scores from baseline to end of treatment phase and end of placebo phase.	Baseline and 3 weeks
Adverse events	side-effects checklist	Baseline and 3 weeks

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: L. Elliot Hong, MD, University of Maryland, College Park

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 23, 2013

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: HP-00056458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No