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Trial registered on ANZCTR
Registration number
ACTRN12612000952842
Ethics application status
Approved
Date submitted
4/09/2012
Date registered
5/09/2012
Date last updated
5/02/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Bioavailability of orally administered gamma-glutamylcysteine
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Scientific title
Bioavailability study to determine whether a single oral dose of gamma-glutamylcysteine (GGC) sodium salt can transiently increase glutathione content of the white blood cells and brain tissue of healthy volunteers.
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Secondary ID [1]
281161
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
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.
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Condition category
Condition code
Other
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0
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Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
On separate days with a one week washout, participants will receive double blinded single oral doses of gamma-glutamylcysteine (GGC) in the range of 250 mg to 4g (placebo control glucose) . Participants will range from 18 to 20 years, with the only exclusions being smokers, pregnancy, and metal medical implants (MRI). Glutathione levels will be monitored periodically for up to 7 hours following administration by the taking of blood samples (lymphocyte glutathione content) and/or by MRI/MRS (brain tissue content).
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
The experimental design will involve a randomized double blind crossover group, dose comparison procedure. To mask the dosage level, all patients will receive sixteen 250 mg capsules for each tested dose with the capsules containing either gamma-glutamylcysteine or glucose (placebo). Both groups of gelatin capsules will be identical .
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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).
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Assessment method [1]
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Timepoint [1]
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Pre-dosage and at 90, 180, 360, 450, and 540 minutes
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Primary outcome [2]
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Changes in glutathione levels in brain tissue will be determined by Magnetic Resonance Imaging/Spectroscopy (MRI/MRS) scans.
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Assessment method [2]
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Timepoint [2]
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Basal (initial) glutathione levels will be determined by a MRI/MRS scan (15 -
20 min) prior to GGC administration. Participants will be further scanned at 2, 4, and 7 hours,
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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Eligibility
Key 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]
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Minimum age
20
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
smokers, alcoholics, any illnesses requiring regular medication
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be volunteers who are friends, family or colleagues of the researchers who are familiar with the research and the potential health benefits of GGC. They will be randomly allocated ("drawing out of a hat" ) to three groups either A, B, or C. The allocations and the GGC administrations will be managed and performed by UNSW colleagues not associated with the trial objective to ensure the researchers are blinded to the dose levels.
The sequence of the participants' dose schedule will be determined randomly. Once Group A has completed the trial, the data will be analysed for dose response significance. If there is insufficient statistical power for any observed trends, then Group B will commence and complete the trial. The compiled Group A and Group B data will be statistical analysed and Group C will commence the trial should the statistical power still be insufficient.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by drawing out of a hat
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
Nil
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Phase
Phase 1
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Type of endpoint/s
Bio-availability
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Statistical methods / analysis
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Recruitment
Recruitment status
Suspended
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Date of first participant enrolment
Anticipated
25/03/2013
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Actual
25/03/2013
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Date of last participant enrolment
Anticipated
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Actual
15/06/2016
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Date of last data collection
Anticipated
1/07/2020
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Actual
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Sample size
Target
18
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Accrual to date
18
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of New South Wales
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Address [1]
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School of Biotechnology and Biomolecular Sciences (BABS)
Faculty of Science, UNSW, Sydney, NSW, 2052
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of New South Wales
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Address
c/- School of Biotechnology and Biomolecular Sciences (BABS)
Faculty of Science, UNSW, Sydney, NSW, 2052
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
284756
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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UNSW Human Research Ethics Committee
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Ethics committee address [1]
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University of New South Wales, Sydney, NSW, 2052
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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04/09/2012
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Approval date [1]
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10/10/2012
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Ethics approval number [1]
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HC12511
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Summary
Brief summary
Gamma glutamylcysteine (GGC) is commonly found in many foods, such as garlic and whey, which are anecdotally associated with numerous health benefits. GGC can potentially be used by the body to synthesise the commonly termed “master antioxidant” glutathione, which is responsible for protecting our cells from oxidative stress and for the elimination of toxins. As we age our body’s capacity to produce sufficient glutathione progressively declines leaving us vulnerable to many age related diseases and disorders. In this study, we will investigate whether oral administered GGC can be of benefit in increasing the glutathione content in blood cells in young. mature and aged populations.
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Trial website
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Trial related presentations / publications
The trials initial pilot findings have been published in Redox Biology and is open access available
Zarka, M and Bridge W. Oral administration of gamma-glutamylcysteine increases intracellular glutathione levels above homeostasis in a randomised human trial pilot study. Redox Biology 2017 11 631-636.
Link. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5284489/
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Public notes
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Contacts
Principal investigator
Name
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Dr Dr Wallace Bridge
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Address
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c/- School of Biotechnology and Biomolecular Sciences, Faculty of Science University of New South Wales Sydney, 2052, NSW
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Country
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Australia
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Phone
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+61 2 9385 1297
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr Wallace Bridge
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Address
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c/- School of Biotechnology and Biomolecular Sciences, Faculty of Science University of New South Wales Sydney, NSW, 2052
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Country
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Australia
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Phone
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+61 2 9385 1297
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Dr Wallace Bridge
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Address
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c/- School of Biotechnology and Biomolecular Sciences, Faculty of Science University of New South Wales Sydney, NSW, 2052
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Country
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Australia
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Phone
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+61 2 9385 1297
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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