Biological Evaluation of Dietary Supplement Liposomal Glutathione

University of Maryland Baltimore (UMB)

Status

Completed

Conditions

Schizophrenia

Treatments

Dietary Supplement: Liposomal glutathione

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01967667

HP-00056458

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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)