Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
NCT ID: NCT07064005
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2026-01-15
2027-11-27
Brief Summary
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1. To study the enrichment of master antioxidant, glutathione (GSH) levels in brain and blood of these PD patients compared to baseline due to GGC supplementation.
2. To study the changes in motor function, cognitive skills in PD patients due to GGC oral supplementation
3. To study impact of GGC on gut health on the PD patients.
Detailed Description
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The neuropsychological examination and motor function will be performed in pre and post GGC supplementation.
This study will provide the relation of brain GSH enrichment with motor performance.
Our study will also provide any possible correlation with reduction of dysbiosis of the gut microbiome with GSH enrichment.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Gamma - Glutamylcysteine
Patients will receive GGC tablet 400mg orally twice a day (morning and in the afternoon).
Gamma- glutamylcysteine
400 mg (two times) per day
Interventions
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Gamma- glutamylcysteine
400 mg (two times) per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Montreal Cognitive Assessment (MoCA) greater than or equal to 26.
* Age (50 to 80 years of age).
* Ability to read and write in English.
Exclusion Criteria
* Subjects with claustrophobia.
* Patients with a clinical diagnosis of Parkinson's disease dementia or dementia with Lewy bodies.
* Subjects with a history of cancer.
* Subjects with active psychosis or delirium.
* Subjects with chronic kidney (creatinine \> 1.5mg/dL) or liver disease (AST/ALT \> 2 upper limit of normal) within 30 days prior to enrolment.
* Subjects on antioxidant therapy (ashwagandha, gingko biloba or N-acetylcysteine) or illicit drug abuse/dependence (cocaine, heroin, marijuana, or fentanyl).
* Subjects with previous traumatic head injury.
50 Years
80 Years
ALL
No
Sponsors
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Waste Connections Inc
UNKNOWN
Pravat Mandal
OTHER
Responsible Party
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Pravat Mandal
Research Assistant Professor
Principal Investigators
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Pravat K Mandal, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Dias V, Junn E, Mouradian MM. The role of oxidative stress in Parkinson's disease. J Parkinsons Dis. 2013;3(4):461-91. doi: 10.3233/JPD-130230.
Shukla D, Goel A, Mandal PK, Joon S, Punjabi K, Arora Y, Kumar R, Mehta VS, Singh P, Maroon JC, Bansal R, Sandal K, Roy RG, Samkaria A, Sharma S, Sandhilya S, Gaur S, Parvathi S, Joshi M. Glutathione Depletion and Concomitant Elevation of Susceptibility in Patients with Parkinson's Disease: State-of-the-Art MR Spectroscopy and Neuropsychological Study. ACS Chem Neurosci. 2023 Dec 20;14(24):4383-4394. doi: 10.1021/acschemneuro.3c00717. Epub 2023 Dec 5.
Mandal PK, Dwivedi D, Joon S, Goel A, Ahasan Z, Maroon JC, Singh P, Saxena R, Roy RG. Quantitation of Brain and Blood Glutathione and Iron in Healthy Age Groups Using Biophysical and In Vivo MR Spectroscopy: Potential Clinical Application. ACS Chem Neurosci. 2023 Jun 21;14(12):2375-2384. doi: 10.1021/acschemneuro.3c00168. Epub 2023 May 31.
Other Identifiers
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2001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY24120097
Identifier Type: -
Identifier Source: org_study_id