Pilot Study of Oral Liposomal Glutathione Supplementation on Levels of Glutathione in Blood and Biomarkers of Oxidative Stress and Immune Function in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Glutathione levels in blood
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy English-speaking male and female volunteers
- •Baseline blood glutathione level of ≤ 0.9 mmol/l
- •Non-smoking individuals
排除标准
- •No history or evidence of disease including cancer, diabetes, heart disease.
- •Not taking glutathione as a dietary supplement
- •Not taking high-dose antioxidant supplements
结局指标
主要结局
Glutathione levels in blood
时间窗: Baseline and 4 weeks
次要结局
- Measure immune function biomarkers in blood(Baseline and 4 weeks)
研究者
Raghu Sinha
Associate Professor of Biochemistry and Molecular Biology
Milton S. Hershey Medical Center
