Oral Liposomal Glutathione Supplementation in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT02278822|
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Low dose oral liposomal glutathione supplementation Other: High dose oral liposomal glutathione supplementation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|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|
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
- Glutathione levels in blood [ Time Frame: Baseline and 4 weeks ]
- Measure immune function biomarkers in blood [ Time Frame: Baseline and 4 weeks ]
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
|United States, Pennsylvania|
|M.S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Raghu Sinha, PhD||M.S. Hershey Medical Center|