Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations
研究概览
简要总结
In this study, we will evaluate the effectiveness of several doses of oral selenomethionine in raising biomarkers of selenium status including plasma selenium concentrations.
详细描述
Results of studies with animal tumor models and human clinical trials suggest that the essential nutrient selenium can be anti-tumorigenic if consumed at levels greater than nutritional requirements. If it is possible to increase plasma selenium concentrations above 120 nanograms per milliliter with less than 200 micrograms of selenium daily, then it is possible that supplementation can be accomplished through the use of selenium-containing foods.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to swallow capsules
- •body mass index less than 40
排除标准
- •Pregnancy
- •Chronic liver or kidney disease
- •taking medication that might affect liver and/or kidney
- •blood pressure 140/90 or higher
- •already taking more than 50 micrograms of selenium
结局指标
主要结局
Evaluation of effectiveness of consuming oral doses of L-selenomethionine in raising plasma selenium concentrations
时间窗: Baseline, and after 3, 6, 9, and 12 months of supplementation
次要结局
- Biomarkers of selenium status will be determined in urine, buccal cells, and plasma. White blood cells will be analyzed to identify DNA damage, reflecting the degree of oxidative damage and evaluate the status of antioxidant repair mechanisms.(Baseline and after 12 months of supplementation)