Clinical trial NCT02278822: Oral Liposomal Glutathione Supplementation in Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Glutathione levels in blood
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Measure immune function biomarkers in blood
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: M.S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: M.S. Hershey Medical Center
name: Raghu Sinha, PhD
role: PRINCIPAL_INVESTIGATOR
References: