Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-03 @ 2:32 AM
Study NCT ID:
NCT01967667
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2013-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Evaluation of Dietary Supplement Liposomal Glutathione
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591311', 'term': 'glutathione pegylated liposomal doxorubicin'}, {'id': 'D005978', 'term': 'Glutathione'}], 'ancestors': [{'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2013-10-17', 'studyFirstSubmitQcDate': '2013-10-17', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'BPRS', 'timeFrame': 'Baseline and 3 weeks', 'description': 'Change in brief psychiatric rating scale scores from baseline to end of treatment phase and end of placebo phase.'}, {'measure': 'Adverse events', 'timeFrame': 'Baseline and 3 weeks', 'description': 'side-effects checklist'}], 'primaryOutcomes': [{'measure': 'Glutathione levels', 'timeFrame': 'Baseline and 3 weeks', 'description': 'Change of glutathione levels from baseline to following 3 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'oxidative stress biomarker', 'timeFrame': 'baseline and 3 weeks', 'description': 'blood levels of lipid peroxidation'}, {'measure': 'inflammatory marker', 'timeFrame': 'baseline and 3 weeks', 'description': 'Blood levels of cytokines as biomarkers of inflammation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Additional information about this dietary supplement:\n\n* Glutathione is an antioxidant naturally produced in our body. Glutathione protects the brain and other organs from oxidative stress.\n* 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.\n* Glutathione can be supplied through dietary supplement. However, if taken plainly, it easily breaks down in our gut.\n* 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.\n* Liposome-wrapped glutathione is not a drug or medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range: 18-60\n* DSM diagnosis of schizophrenia spectrum disorder, including schizophrenia, schizoaffective disorder, and schizophreniform disorder\n* Ability to give written informed consent (Evaluation to Sign Consent score 10 or greater)\n* Clinically stable with no change in antipsychotic medications nor significant increase of daily dose for 2 weeks prior to enrollment\n* Low baseline blood glutathione level (GSH \\< 890 umol/l)\n\nExclusion Criteria:\n\n* History of major medical illness including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)\n* History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration\n* DSM diagnosis of substance dependence within 6 months except nicotine and marijuana, or substance abuse in past month\n* Uncontrolled blood pressure (persistent systolic above 165 or diastolic above 100)\n* On medication containing cholesterol absorption inhibitor such as ezetimibe (Brand names Zetia, Ezetrol, Vytorin, and Inegy)\n* Women who have positive urine pregnancy tests\n* Women who plan to become pregnant, or are breastfeeding\n* Unable to undergo MRI scanning due to metallic devices or objects or claustrophobia\n* 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\n* History of allergy to soy or soy products\n* Hyperlipidemia (baseline LDL \\> 1.5 x upper limit of normal)\n* Liver impairment (baseline AST or ALT \\> 2.0 x upper limit of normal)'}, 'identificationModule': {'nctId': 'NCT01967667', 'briefTitle': 'Biological Evaluation of Dietary Supplement Liposomal Glutathione', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Biological Evaluation of Dietary Supplement Liposomal Glutathione', 'orgStudyIdInfo': {'id': 'HP-00056458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liposomal glutathione', 'description': 'dose steps', 'interventionNames': ['Dietary Supplement: Liposomal glutathione']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'dose steps', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Liposomal glutathione', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ReadiSorb glutathione'], 'description': 'Escalating dose steps', 'armGroupLabels': ['Liposomal glutathione']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Readisorb solution without glutathione'], 'description': 'escalating dose steps', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21228', 'city': 'Catonsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Psychiatric Research Center', 'geoPoint': {'lat': 39.27205, 'lon': -76.73192}}], 'overallOfficials': [{'name': 'L. Elliot Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, College Park'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'MPRC', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}