- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02278822
Oral Liposomal Glutathione Supplementation in Healthy Subjects
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- M.S. Hershey Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
High dose oral liposomal glutathione supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glutathione levels in blood
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure immune function biomarkers in blood
Time Frame: Baseline and 4 weeks
|
Baseline and 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Raghu Sinha, PhD, M.S. Hershey Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00000405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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