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Oral Glutathione Supplementation on the Levels of Blood Glutathione

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ClinicalTrials.gov Identifier: NCT01044277
Recruitment Status : Terminated (Drugs unavailable)
First Posted : January 7, 2010
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Healthy Adults Drug: Glutathione supplementation Drug: Gluthathione peroxidases Other: Placebo

Detailed Description:

This is a randomized double-blind, placebo-controlled study in which the treatment allocations will be kept sealed until the final statistical evaluation. The design will include the recruitment of 60 healthy subjects (30-79 yr of age) randomized into 3 groups. A total of 48 subjects, 16 per group will be required based upon power calculations and results from a previous clinical trial with selenium. An additional 4 subjects per group will be placed on trial to account for possible attrition or non-compliance. Blood, urine and exfoliated buccal mucosal samples will be obtained from all subjects at baseline. Questionnaire data on usual dietary intake will also be obtained at baseline. Eligible subjects will be required to have not have taken any high dose antioxidant supplements for at least 1 month prior to the study. Subjects will then begin supplementation according to the following schedule:

Group A, GSH (500 mg, 2 times daily); Group B, GSH (125 mg, 2 times daily); Group C, placebo (2 times daily). Eligible participants who sign the informed consent will be randomly assigned to either placebo or high or low dose Glutathione groups. Participants will be asked not to consume any other high-dose vitamin, multi-vitamin, or mineral supplements containing glutathione throughout the study in order to prevent variation in dose of supplemental GSH between subjects. Supplementation will continue for 6 months with biological samples collected at 1, 3 and 6 months after baseline. At 6 months, supplementation will be discontinued. A final collection of biological samples will occur 1 month afterwards. Compliance will be monitored by pill count.

Levels of glutathione will be measured in plasma, lymphocytes, and red blood cells as well as in exfoliated buccal mucosal cells. Biomarkers of oxidative stress will include blood levels of glutathionylated proteins and 8-isoprostanes and urine levels of 8-hydroxydeoxyguanosine. Glutamylcystine ligase and GST activities, and C-reactive protein will be determined in blood. Immune function biomarkers will be analyzed including t-natural killer cell cytotoxicity, lymphoproliferation, neutrophils phagocytosis, neutrophil respiratory burst assays.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double-Blind - GSH 500 mg/GSH 125 mg/Placebo
Primary Purpose: Basic Science
Official Title: 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)
Study Start Date : February 2010
Primary Completion Date : September 2011
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group A

Glutathione supplementation-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo

Other name Gluthathione peroxidases

Drug: Glutathione supplementation
500 mg, two times daily
Other Names:
  • Gluthathione Peroxidates
  • GSH
Experimental: Group B

Glutathione supplementation-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo

Other name Gluthathione peroxidases

Drug: Gluthathione peroxidases
125 mg, two times daily
Other Names:
  • Glutathione supplementation
  • GSH
Placebo Comparator: Group C
Placebo-Double-Blind - GSH 500 mg/GSH 125 mg/Placebo
Other: Placebo
2 times daily
Other Names:
  • Gluthathione peroxidases
  • GSH


Outcome Measures

Primary Outcome Measures :
  1. Evaluation of the effect of glutathione on key biomarkers [ Time Frame: 6 to 7 months ]

Secondary Outcome Measures :
  1. Evaluations will be carried out to expand the above comparison by including adjustments for potential prognostic factors. [ Time Frame: 6 to 7 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History or evidence of disease including cancer, diabetes, heart disease
  • Subjects who smoke
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044277


Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: John P. Richie, Ph.D. Milton S. Hershey Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John P. Richie, Professor of Public Health Sciences and Pharmacology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01044277     History of Changes
Other Study ID Numbers: PSHCI 09-059
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At this time we have no plan for sharing, however, if the need should arise, then sharing may be a possibility.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John P. Richie, Milton S. Hershey Medical Center:
glutathione
gluthathione peroxidases
GSH