Biological Evaluation of Dietary Supplement Liposomal Glutathione
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01967667|
Recruitment Status : Suspended (lack of funding)
First Posted : October 23, 2013
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Dietary Supplement: Liposomal glutathione Dietary Supplement: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Liposomal glutathione
Dietary Supplement: Liposomal glutathione
Escalating dose steps
Other Name: ReadiSorb glutathione
Placebo Comparator: Placebo
Dietary Supplement: Placebo
escalating dose steps
Other Name: Readisorb solution without glutathione
- Glutathione levels [ Time Frame: Baseline and 3 weeks ]Change of glutathione levels from baseline to following 3 weeks of treatment.
- oxidative stress biomarker [ Time Frame: baseline and 3 weeks ]blood levels of lipid peroxidation
- inflammatory marker [ Time Frame: baseline and 3 weeks ]Blood levels of cytokines as biomarkers of inflammation
- 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.
- Adverse events [ Time Frame: Baseline and 3 weeks ]side-effects checklist
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
|United States, Maryland|
|Maryland Psychiatric Research Center|
|Catonsville, Maryland, United States, 21228|
|Principal Investigator:||L. Elliot Hong, MD||University of Maryland, College Park|