Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 580 for:    reduced glutathione

Oral Liposomal Glutathione Supplementation in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02278822
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Raghu Sinha, Milton S. Hershey Medical Center

Brief Summary:
This trial is designed to provide evidence of the efficacy of liposomal glutathione supplementation on healthy adults. The investigators anticipate that liposomal glutathione supplementation will enhance the levels of blood glutathione and improve the immune functions.

Condition or disease Intervention/treatment Phase
Healthy Other: Low dose oral liposomal glutathione supplementation Other: High dose oral liposomal glutathione supplementation Not Applicable

Detailed Description:

This is a randomized study on healthy individuals. The study design includes the recruitment of 12 healthy male and female subjects (50-80 yr of age) randomized into 2 groups of 6 each (liposomal glutathione at 500 mg/day or liposomal glutathione at 1000 mg/day). Blood and urine samples will be obtained from all subjects 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, liposomal glutathione (500 mg daily), Group B, liposomal glutathione (1000 mg daily)

Eligible participants who sign the informed consent will be randomly assigned to either low dose or high 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 liposomal glutathione between subjects. Participants are to limit their consumption of alcohol in the study to no more than 5 oz. of alcohol per week. Supplementation will continue for 1 month with biological samples collected at 1, 2 and 4 weeks after baseline.

Levels of glutathione will be measured in whole blood, erythrocytes, lymphocytes and plasma. The biomarkers of oxidative stress will include urinary 8-isoprostane and urinary 8-hydroxydeoxyguanosine. Immune function biomarkers will be analyzed including lymphocyte proliferation and natural killer (NK) cell cytotoxicity.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study of Oral Liposomal Glutathione Supplementation on Levels of Glutathione in Blood and Biomarkers of Oxidative Stress and Immune Function in Healthy Adults
Study Start Date : November 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Arm Intervention/treatment
Experimental: Low dose oral liposomal glutathione
Intervention: low dose oral liposomal glutathione supplementation. 500 mg oral liposomal glutathione each day for 4 weeks.
Other: Low dose oral liposomal glutathione supplementation
Low dose oral liposomal glutathione supplementation

Experimental: High dose oral liposomal glutathione
Intervention: high dose oral liposomal glutathione supplementation. 1000 mg oral liposomal glutathione each day for 4 weeks.
Other: High dose oral liposomal glutathione supplementation
High dose oral liposomal glutathione supplementation




Primary Outcome Measures :
  1. Glutathione levels in blood [ Time Frame: Baseline and 4 weeks ]

Secondary Outcome Measures :
  1. Measure immune function biomarkers in blood [ Time Frame: Baseline and 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy English-speaking male and female volunteers
  • Baseline blood glutathione level of ≤ 0.9 mmol/l
  • Non-smoking individuals

Exclusion Criteria:

  • No history or evidence of disease including cancer, diabetes, heart disease.
  • Not taking glutathione as a dietary supplement
  • Not taking high-dose antioxidant supplements

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): NCT02278822


Locations
Layout table for location information
United States, Pennsylvania
M.S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Raghu Sinha, PhD M.S. Hershey Medical Center

Layout table for additonal information
Responsible Party: Raghu Sinha, Associate Professor of Biochemistry and Molecular Biology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02278822     History of Changes
Other Study ID Numbers: STUDY00000405
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016