Oral Glutathione Supplementation on the Levels of Blood Glutathione
Effect of Oral Glutathione Supplementation on the Levels of Blood Glutathione and Markers of Oxidative Stress in Healthy Adults (Glutathione Supplementation and Health (GSH) Study)
1 other identifier
interventional
61
1 country
1
Brief Summary
This trial is designed to provide evidence of the efficacy of glutathione supplementation and health(GSH) and includes the assessment of both short term and long term effects. Based on previous laboratory animal studies and clinical data, the investigators anticipate that the effects of oral GSH supplementation will be progressive and cumulative. The study will also allow for the evaluation of effects of withdrawal of the supplement on the outcome variables.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 6, 2022
August 1, 2022
1.6 years
January 6, 2010
August 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the effect of glutathione on key biomarkers
Blood glutathione status
6 to 7 months
Secondary Outcomes (1)
Evaluations will be carried out to expand the above comparison by including adjustments for potential prognostic factors.
6 to 7 months
Study Arms (3)
Group A
EXPERIMENTALGlutathione supplementation-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo Other name Gluthathione peroxidases
Group B
EXPERIMENTALGlutathione supplementation-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo Other name Gluthathione peroxidases
Group C
PLACEBO COMPARATORPlacebo-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo
Interventions
500 mg, two times daily
125 mg, two times daily
Eligibility Criteria
You may qualify if:
- Healthy male and females between the ages of 30 and 79 years of age
- Not taking glutathione as a dietary supplement
- Not taking high dose antioxidant supplement prior to 1 month
- Baseline blood glutathione level of \< 1 mmol/L
You may not qualify if:
- History or evidence of disease including cancer, diabetes, heart disease
- Subjects who smoke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Related Publications (1)
Richie JP Jr, Nichenametla S, Neidig W, Calcagnotto A, Haley JS, Schell TD, Muscat JE. Randomized controlled trial of oral glutathione supplementation on body stores of glutathione. Eur J Nutr. 2015 Mar;54(2):251-63. doi: 10.1007/s00394-014-0706-z. Epub 2014 May 5.
PMID: 24791752DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
John P. Richie, Ph.D.
Milton S. Hershey Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-Blind - GSH 500 mg/GSH 125 mg/Placebo
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Public Health Sciences and Pharmacology
Study Record Dates
First Submitted
January 6, 2010
First Posted
January 7, 2010
Study Start
February 1, 2010
Primary Completion
September 1, 2011
Study Completion
October 1, 2014
Last Updated
September 6, 2022
Record last verified: 2022-08