Oral Liposomal Glutathione Supplementation in Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Low dose oral liposomal glutathione supplementation; Other: High dose oral liposomal glutathione supplementation

• Registration Number: NCT02278822
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-10-11
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-30
• Study Start: 2014-11
• Primary Completion: 2015-04
• Study Completion: 2016-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-07
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose oral liposomal glutathione	Low dose oral liposomal glutathione supplementation	Intervention: low dose oral liposomal glutathione supplementation. 500 mg oral liposomal glutathione each day for 4 weeks.
High dose oral liposomal glutathione	High dose oral liposomal glutathione supplementation	Intervention: high dose oral liposomal glutathione supplementation. 1000 mg oral liposomal glutathione each day for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Glutathione levels in blood	Baseline and 4 weeks

Secondary Outcome Measures

Name	Time	Method
Measure immune function biomarkers in blood	Baseline and 4 weeks

Trial Locations

Locations (1)

M.S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States