Randomized, Crossover, Double Blinded, Non-inferiority Study of Three Products Rich in Organic Silicon, in Postprandrial Situation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- concentration of sillicium in urine samples
研究概览
简要总结
The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.
详细描述
The objective of the present study is to evaluate the non-inferiority of the absorption parameters of three silicon supplements in human volunteers.
Participants: 5 healthy men over 18 years old, with normal serum creatinine levels. Treatment consists of one product consumption every week, and measuring postprandrial response at 0, 30, 60, 90, 120, 180, 240 and 360 min, in blood, and urine in two periods of three hours each.
The statistical analysis will follow the principles specified in the guidelines of the ICHE and CPMP/EWP/908/99 ICHE Points to Consider on Multiplicity Issues in Clinical Trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adults men or women (>18 years old)
- •With normal serum creatinine levels.
- •Written informed consent provided before the initial screening visit.
排除标准
- •Suffering from chronic diseases
- •Suffering from intestinal disorders
- •Consuming silicon supplements in the 7 days prior to inclusion in the study.
- •Consuming medicines containing silicon in the 7 days prior to inclusion in the study.
- •Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
- •Failing to follow study guidelines.
结局指标
主要结局
concentration of sillicium in urine samples
时间窗: Urine will be collected in two 3-h collections (0-180min and 181-360 min) in two separate containers at Visit 1, Visit 2 and Visit 3 (1 week between visits)
concentration of sillicium in urine samples will be measured by inductively coupled plasma optical emission spectrometry.
次要结局
- concentration of sillicium in plasma(Blood samples will be collected to determine baseline plasma silicon value (time 0 min = T0). After ingestion of one of the study products, additional blood samples will be collected at 30, 60, 90 and 120 min at Visit 1, Visit 2 and Visit 3)