Oral Glutathione Supplementation on the Levels of Blood Glutathione

NCT ID: NCT01044277

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-10-31

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.

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.

Conditions

Healthy Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Group A

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

Other name Gluthathione peroxidases

Group Type: EXPERIMENTAL

Glutathione supplementation

Intervention Type: DRUG

500 mg, two times daily

Group B

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

Other name Gluthathione peroxidases

Group Type: EXPERIMENTAL

Gluthathione peroxidases

Intervention Type: DRUG

125 mg, two times daily

Group C

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

2 times daily

Interventions

Glutathione supplementation

500 mg, two times daily

Intervention Type: DRUG

Gluthathione peroxidases

125 mg, two times daily

Intervention Type: DRUG

Placebo

2 times daily

Intervention Type: OTHER

Other Intervention Names

Gluthathione Peroxidates; GSH; Glutathione supplementation; GSH; Gluthathione peroxidases; GSH

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

John P. Richie

Professor of Public Health Sciences and Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John P. Richie, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24791752 (View on PubMed)

Other Identifiers

PSHCI 09-059

Identifier Type: -

Identifier Source: org_study_id