Oral Liposomal Glutathione Supplementation in Healthy Subjects

NCT ID: NCT02278822

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-03-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Low dose oral liposomal glutathione

Intervention: low dose oral liposomal glutathione supplementation. 500 mg oral liposomal glutathione each day for 4 weeks.

Group Type: EXPERIMENTAL

Low dose oral liposomal glutathione supplementation

Intervention Type: OTHER

Low dose oral liposomal glutathione supplementation

High dose oral liposomal glutathione

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

Group Type: EXPERIMENTAL

High dose oral liposomal glutathione supplementation

Intervention Type: OTHER

High dose oral liposomal glutathione supplementation

Interventions

Low dose oral liposomal glutathione supplementation

Low dose oral liposomal glutathione supplementation

Intervention Type: OTHER

High dose oral liposomal glutathione supplementation

High dose oral liposomal glutathione supplementation

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Raghu Sinha

Associate Professor of Biochemistry and Molecular Biology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raghu Sinha, PhD

Role: PRINCIPAL_INVESTIGATOR

M.S. Hershey Medical Center

Locations

M.S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00000405

Identifier Type: -

Identifier Source: org_study_id