Quantitation of Brain and Blood Glutathione and Iron in Healthy Age Groups Using Biophysical and In Vivo MR Spectroscopy: Potential Clinical Application.
Pravat K Mandal, Divya Dwivedi, Shallu Joon...
https://pubmed.ncbi.nlm.nih.gov/37257017/Actively Recruiting
Led by Pravat Mandal · Updated on 2026-05-04
12
Participants Needed
1
Research Sites
12 weeks
Total Duration
Researchers are evaluating the effects of oral Gamma-glutamylcysteine GGC supplementation in people with early Parkinsons Disease PD. The study aims to measure changes in the brain and blood levels of glutathione, a key antioxidant, and how these changes relate to motor function, cognitive skills, and gut health in PD patients. This pilot trial focuses on understanding how GGC may influence disease progression through its antioxidant properties. Participants will take a 400 mg GGC tablet twice daily, once in the morning and once in the afternoon, for 12 months. Brain glutathione and iron levels will be measured using Magnetic Resonance Spectroscopy and Imaging before and after supplementation. Blood levels of glutathione and iron will also be tested at these times. Motor function and cognitive abilities will be assessed before and after the treatment period to monitor changes associated with GGC use. During the study, participants will undergo neuropsychological exams, motor function testing, and gut microbiome evaluations. Assessments include the Movement Disorders Society-Unified Parkinsons Disease Rating Scale and several cognitive tests such as the Repeatable Battery for the Assessment of Neuropsychological Status. Researchers will track glutathione and iron levels, motor and cognitive changes, and psychological distress over the 12-month period. This comprehensive monitoring will help evaluate the impact of GGC supplementation on PD symptoms and biological markers.
CONDITIONS
Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
P
Pravat K MANDAL, PHD
N
Nazia Pillar, M.S
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Pravat Mandal
Lead Sponsor
Waste Connections Inc
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Oral Gamma-glutamylcysteine (GGC) Supplementation | Standard Symptomatic Care (No GGC Supplementation) |
|---|---|---|
| What it is | Daily oral supplementation with gamma-glutamylcysteine (GGC), an antioxidant precursor, given at 400 mg twice per day. | Ongoing symptomatic therapy using established medications and interventions for Parkinson's Disease (dopaminergic and non-dopaminergic regimens as clinically indicated), without GGC supplementation. |
| Role in trial | Investigational intervention being evaluated for its effect on brain and blood glutathione and iron levels in Parkinson's Disease. | Represents the usual care outside the clinical trial, serving as the clinical context for investigational supplementation. |
| Primary use | Explores whether boosting antioxidant glutathione via GGC supplementation can alter brain or blood oxidative stress markers and modulate clinical and neuropsychological measures in Parkinson's Disease. | Aims to control symptoms, maintain functional ability, and improve quality of life in people living with Parkinson's Disease, without altering oxidative stress markers through GGC. |
| How it is given or performed | Participants take oral GGC capsules twice daily over 12 months, alongside their usual medications. | Participants continue their standard medications and therapies prescribed for Parkinson's Disease without the addition of GGC. |
| Evidence status | Efficacy and safety in Parkinson's Disease are under early clinical investigation with no published patient outcome data from this trial. | Symptomatic treatments are supported by extensive published evidence and clinical guidelines for improving movement and quality of life. Effects on oxidative stress are not the main established benefit. |
| Important limitations | Small sample size (12 participants), single-center, open-label design, and absence of a comparator group mean results may not generalize. Impact on clinical outcomes and safety are not yet established. | Standard therapies may not address disease progression or oxidative stress modifications. Individual responses and side effect profiles vary, requiring regular medical adjustment. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 12 months
Participants take Gamma-glutamylcysteine tablets 400 mg twice daily for brain glutathione enrichment.
Visits scheduled before and after 12 months of supplementation
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/38050970/Vera Dias, Eunsung Junn, M Maral Mouradian
https://pubmed.ncbi.nlm.nih.gov/24252804/Pravat Mandal
Lead Sponsor
Waste Connections Inc
Collaborating Sponsor