Biological Evaluation of Dietary Supplement Liposomal Glutathione

Schizophrenia Clinical Trial

Official title:

Biological Evaluation of Dietary Supplement Liposomal Glutathione

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967667
• Other study ID #: HP-00056458
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: February 2021

Study information

• Verified date: April 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Dietary Supplement:
• Liposomal glutathione
Escalating dose steps
• Placebo
escalating dose steps

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center	Catonsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BPRS	Change in brief psychiatric rating scale scores from baseline to end of treatment phase and end of placebo phase.	Baseline and 3 weeks
Other	Adverse events	side-effects checklist	Baseline and 3 weeks
Primary	Glutathione levels	Change of glutathione levels from baseline to following 3 weeks of treatment.	Baseline and 3 weeks
Secondary	oxidative stress biomarker	blood levels of lipid peroxidation	baseline and 3 weeks
Secondary	inflammatory marker	Blood levels of cytokines as biomarkers of inflammation	baseline and 3 weeks