SchizophreniaNCT01967667
Biological Evaluation of Dietary Supplement Liposomal Glutathione
A study testing Liposomal glutathione in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Liposomal glutathione
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Liposomal glutathione, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal glutathioneDietary supplement
Also called ReadiSorb glutathione
Escalating dose steps
PlaceboDietary supplement
Also called Readisorb solution without glutathione
escalating dose steps
| Study group | Role | What they receive |
|---|---|---|
| Liposomal glutathione | Experimental | dose steps Receives: Dietary Supplement: Liposomal glutathione |
| Placebo | Placebo comparator | dose steps Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutathione levels
Change of glutathione levels from baseline to following 3 weeks of treatment.
Measured: Baseline and 3 weeks
Secondary outcomes (2)
oxidative stress biomarker
blood levels of lipid peroxidation
Measured: baseline and 3 weeks
inflammatory marker
Blood levels of cytokines as biomarkers of inflammation
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionFeb 2021
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- L. Elliot Hong, MD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967667
- Sponsor's protocol ID
- HP-00056458
- Status last verified
- Apr 2021
- First submitted
- 17 Oct 2013
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Evaluation of Dietary Supplement Liposomal Glutathione
- ClinicalTrials.gov ID
- NCT01967667
- Acronym / sponsor ID
- HP-00056458
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal glutathione | Experimental | Dietary Supplement: Liposomal glutathionedose steps |
| Placebo | Placebo comparator | Dietary Supplement: Placebodose steps |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal glutathioneAlso: ReadiSorb glutathioneEscalating dose steps | Dietary supplement | Liposomal glutathione |
| PlaceboAlso: Readisorb solution without glutathioneescalating dose steps | Dietary supplement | Placebo |
Primary outcome
Glutathione levels
Time frame: Baseline and 3 weeks
Change of glutathione levels from baseline to following 3 weeks of treatment.
2 secondary outcomes
oxidative stress biomarker
Time frame: baseline and 3 weeks
inflammatory marker
Time frame: baseline and 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L. Elliot Hong, MD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal glutathione in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glutathione levels (time frame: Baseline and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.