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Biological Evaluation of Dietary Supplement Liposomal Glutathione

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ClinicalTrials.gov Identifier: NCT01967667
Recruitment Status : Suspended (lack of funding)
First Posted : October 23, 2013
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Dietary Supplement: Liposomal glutathione Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Biological Evaluation of Dietary Supplement Liposomal Glutathione
Study Start Date : April 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Arm Intervention/treatment
Experimental: Liposomal glutathione
dose steps
Dietary Supplement: Liposomal glutathione
Escalating dose steps
Other Name: ReadiSorb glutathione

Placebo Comparator: Placebo
dose steps
Dietary Supplement: Placebo
escalating dose steps
Other Name: Readisorb solution without glutathione




Primary Outcome Measures :
  1. Glutathione levels [ Time Frame: Baseline and 3 weeks ]
    Change of glutathione levels from baseline to following 3 weeks of treatment.


Secondary Outcome Measures :
  1. oxidative stress biomarker [ Time Frame: baseline and 3 weeks ]
    blood levels of lipid peroxidation

  2. inflammatory marker [ Time Frame: baseline and 3 weeks ]
    Blood levels of cytokines as biomarkers of inflammation


Other Outcome Measures:
  1. BPRS [ Time Frame: Baseline and 3 weeks ]
    Change in brief psychiatric rating scale scores from baseline to end of treatment phase and end of placebo phase.

  2. Adverse events [ Time Frame: Baseline and 3 weeks ]
    side-effects checklist



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967667


Locations
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United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Investigators
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Principal Investigator: L. Elliot Hong, MD University of Maryland

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Responsible Party: MPRC, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01967667     History of Changes
Other Study ID Numbers: HP-00056458
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders