Bioavailability of orally administered gamma-glutamylcysteine
Phase 1
Suspended
- Conditions
- This bioavailability trial represents an initial investigation in healthy volunteers to determine the potential of gamma-glutamylcysteine (GGC) to augment cellular glutathione levels. Glutathione depletion is associated with numerous age related disorders.Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12612000952842
- Lead Sponsor
- niversity of New South Wales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Aged 20 - 80 years, reasonable health, non-smoker, non alcoholic, not pregnant, and not surgically fitted with metal medical devices (e.g. pace makers, Cochlear implants) .
Healthy body weight [body mass index (BMI) 18.5 - 25 kg/m2]
Exclusion Criteria
smokers, alcoholics, any illnesses requiring regular medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The lymphocytes will be isolated from blood samples using the Ficoll Paque PLUS based method. Following isolation the lymphocytes will be purified and counted using an automated cell sorter with morphology based gating to dispense 10^6 cells per well (96 well microtitre plate) in triplicate. The cells will be lysed and assayed using a Promega glutathione assay kit (luciferase based luminescence detection).[Pre-dosage and at 90, 180, 360, 450, and 540 minutes];Changes in glutathione levels in brain tissue will be determined by Magnetic Resonance Imaging/Spectroscopy (MRI/MRS) scans. [Basal (initial) glutathione levels will be determined by a MRI/MRS scan (15 -<br> 20 min) prior to GGC administration. Participants will be further scanned at 2, 4, and 7 hours, ]
- Secondary Outcome Measures
Name Time Method il[Nil]