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Biological Evaluation of Dietary Supplement Liposomal Glutathione

Primary Purpose

Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Liposomal glutathione

Placebo

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Maryland Psychiatric Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liposomal glutathione

Placebo

Arm Description

dose steps

Outcomes

Primary Outcome Measures

Glutathione levels

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

Secondary Outcome Measures

oxidative stress biomarker

blood levels of lipid peroxidation

inflammatory marker

Blood levels of cytokines as biomarkers of inflammation

Full Information

NCT ID

NCT01967667

First Posted

October 17, 2013

Last Updated

April 27, 2021

Sponsor

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT01967667

Brief Title

Biological Evaluation of Dietary Supplement Liposomal Glutathione

Official Title

Biological Evaluation of Dietary Supplement Liposomal Glutathione

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

April 2014 (Actual)

Primary Completion Date

February 2021 (Actual)

Study Completion Date

February 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liposomal glutathione

Arm Type

Experimental

Arm Description

dose steps

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

dose steps

Intervention Type

Dietary Supplement

Intervention Name(s)

Liposomal glutathione

Other Intervention Name(s)

ReadiSorb glutathione

Intervention Description

Escalating dose steps

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

Readisorb solution without glutathione

Intervention Description

escalating dose steps

Primary Outcome Measure Information:

Title

Glutathione levels

Description

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

Time Frame

Baseline and 3 weeks

Secondary Outcome Measure Information:

Title

oxidative stress biomarker

Description

blood levels of lipid peroxidation

Time Frame

baseline and 3 weeks

Title

inflammatory marker

Description

Blood levels of cytokines as biomarkers of inflammation

Time Frame

baseline and 3 weeks

Other Pre-specified Outcome Measures:

Title

BPRS

Description

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

Time Frame

Baseline and 3 weeks

Title

Adverse events

Description

side-effects checklist

Time Frame

Baseline and 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

L. Elliot Hong, MD

Organizational Affiliation

University of Maryland, College Park

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maryland Psychiatric Research Center

City

Catonsville

State/Province

Maryland

ZIP/Postal Code

21228

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Biological Evaluation of Dietary Supplement Liposomal Glutathione

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