Biological Evaluation of Dietary Supplement Liposomal Glutathione

NCT ID: NCT01967667

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2021-02-28

Brief Summary

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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Liposomal glutathione

dose steps

Group Type: EXPERIMENTAL

Liposomal glutathione

Intervention Type: DIETARY_SUPPLEMENT

Escalating dose steps

Placebo

dose steps

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

escalating dose steps

Interventions

Liposomal glutathione

Escalating dose steps

Intervention Type: DIETARY_SUPPLEMENT

Placebo

escalating dose steps

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

ReadiSorb glutathione; Readisorb solution without glutathione

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

MPRC

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

L. Elliot Hong, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

Maryland Psychiatric Research Center

Catonsville, Maryland, United States

Countries

United States

Other Identifiers

HP-00056458

Identifier Type: -

Identifier Source: org_study_id