Oral Glutathione Supplementation in Older Healthy Adults and Its Effect on the Number of Healthy Days Experienced During Four Months of Supplementation Compared to Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Severity and frequency of Cold / Flu symptoms
研究概览
简要总结
A randomized, double blind placebo-controlled parallel intervention in adults over the age of 50 will be performed. Participants will receive a supplement capsule containing placebo (Crystalline Cellulose) or 500mg of Setria® Glutathione to eat for 120 days. Glutathione is hypothesized to replenish the body's reserves that may be depleted through natural aging process, poor diet, or due to the detoxification process for drugs. The primary end point is the number of healthy days experienced during the duration of the study. Secondary endpoints include cellular and biochemical measures from blood samples taken before and after the study.
详细描述
The long term goal of this investigation is to understand how food components improve immune function, both in its ability to respond to pathogens and its ability to turn off when the response is no longer needed. The goal of this application is to examine mechanisms by which glutathione improves immune cells after consumption. The central hypothesis is that glutathione improves redox status within the cell, thereby improving cell function and increasing the number of healthy days experienced by the participants.
After obtaining informed consent, human participants will receive 500 mg/day of Setria® Glutathione or placebo for 120 days. Peripheral blood mononuclear cells (PBMC), neutrophils and serum will be obtained from blood draws before and after the 120 days. A daily diary of illness will be kept by each participant and will record any incidence of illness, the number of symptoms per incidence, and the number of days in which symptoms are present. This study is powered on the basis that over 120 days, the glutathione-supplemented group would experience 3% more healthy days compared to the placebo group. The analysis indicated 60 people per group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy
- •must have had at least one cold during the previous year
- •age 50-75
- •must discontinue other dietary supplement use
排除标准
- •on arthritis medication
- •on hypertension medication
- •severe allergies
- •compromised immune system
- •high cholesterol, heart failure, angina, etc.
- •diagnoses of diabetes or metabolic syndrome
研究组 & 干预措施
Crystalline Cellulose
looks like and is given in the same way as the experimental treatment but contains no active ingredient
干预措施: Crystalline Cellulose (Dietary Supplement)
Glutathione supplement
500 mg/day Setria glutathione supplement
干预措施: Setria glutathione supplement (Dietary Supplement)
结局指标
主要结局
Severity and frequency of Cold / Flu symptoms
时间窗: 120 days
Participants will record any cold / flu symptoms in log throughout the study duration
次要结局
- Improvement of immune cell function(120 days)