Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Homocysteine levels pre- and post- one month of SAMe administration.
研究概览
简要总结
The purpose of this study is to determine if the oral intake of the dietary supplement SAMe increases blood homocysteine levels in healthy human subjects.
详细描述
S-adenosyl-L-methionine (SAMe or AdoMet) is a commonly used nutritional supplement available in the United States since 1999. SAMe is metabolized to homocysteine, a known cardiovascular risk factor. No study has determined the effect exogenous SAMe administration has on the long-term levels of homocysteine in humans. As a nutritional supplement, SAMe is not regulated by the Food and Drug Administration, despite being used to treat clinical diseases such as depression and osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Homocysteine levels pre- and post- one month of SAMe administration.
时间窗: 1 Month
次要结局
- An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests.(2 Weeks)
研究者
Dietlind Wahner-Roedler
Principal Investigator
Mayo Clinic