Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
Purpose
This study is designed l to evaluate the effects of GGC oral supplementation in early Parkinson's disease (PD) patients. The main objectives of the study are to evaluate: 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.
Condition
- Parkinsons Disease (PD)
Eligibility
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Confirmed Parkinson's Disease diagnosis. - 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
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body. - 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 ≥ 1.5 ULN; ALT ≥ 1.5 ULN) 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Gamma - Glutamylcysteine |
Patients will receive GGC tablet 400mg orally twice a day (morning and in the afternoon). |
|
Recruiting Locations
Pittsburgh, Pennsylvania 15213
More Details
- NCT ID
- NCT07064005
- Status
- Recruiting
- Sponsor
- Pravat Mandal
Detailed Description
This study will measure brain glutathione using non- invasive, state-of-the-art MEGA-PRESS pulse sequence in pre and post GGC supplementation after 12 months. The GSH level will also be measured in the blood in pre and post GGC supplementation. Brain and blood iron level will be measured in pre and post GGC supplementation. 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.