Oral Liposomal Glutathione Supplementation in Healthy Subjects

Penn State Health

Status: Completed

Conditions: Healthy

Treatments: Other: Low dose oral liposomal glutathione supplementation; Other: High dose oral liposomal glutathione supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02278822

STUDY00000405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Low dose oral liposomal glutathione

Experimental group

Description:

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

Treatment:

Other: Low dose oral liposomal glutathione supplementation

High dose oral liposomal glutathione

Experimental group

Description:

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

Treatment:

Other: High dose oral liposomal glutathione supplementation