Genetic Variants in Selenoprotein Genes and Gender Influence Biomarkers of Se Status in Response to Brazil Nut Supplementation in Healthy Brazilians
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 主要终点
- change in Plasma Se concentrations
研究概览
简要总结
This study investigates the effect of genetic variations after supplementation with Brazil nuts in healthy Brazilians. Briefly, all the participants will consume one nut a day for 2 months and will stop the intake for more 2 months. Five blood sampling collection will be performed in one month interval, starting at baseline and ending at 2 months without intervention.
详细描述
Brazil nuts are the richest source of selenium in nature, a micronutrient that has essential functions in human physiology.
Selenium status can be measured by the quantification of biomarkers in the blood. Previous studies have shown that genetic polymorphisms can affect Se status and modulate risk for chronic diseases. In this study, five biomarkers will be quantified in the blood, before and after supplementation with Brazil nuts. The genetic variants will be used to stratify the biomarkers and multivariate linear regressions will be used to explore the influence of the polymorphisms on concentrations of the biomarkers .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 20 and 60 years; not taking vitamin and minerals supplements, not taking antiinflammatory, not having chronic diseases
排除标准
- •athletes, excessive alcohol consumption, being obese, having cancer, cardiovascular disease, diabetes and hypo or hyperthyroidism
研究组 & 干预措施
Brazil Nut supplementation
Consumption of one Brazil nut a day for 2 months followed by 2 months without intervention
干预措施: Brazil nut (Dietary Supplement)
结局指标
主要结局
change in Plasma Se concentrations
时间窗: 4 weeks
measured by ICP-MS (ug/L)
change in Plasma Glutathione Peroxidase 3 activity
时间窗: 4 weeks
measured by kinetic assay in a spectrometer (U/L)
change in Erythrocyte Glutathione Peroxidase 1 activity
时间窗: 4 weeks
measured by kinetic assay in an automatic spectrometer (U/gHb)
change in Erythrocyte Se concentrations
时间窗: 4 weeks
measured by ICP-MS (ug/L)
change in Plasma Selenoprotein P concentrations
时间窗: 4 weeks
measured by ELISA (mg/dL)
次要结局
- change in total cholesterol concentration in serum(4 weeks)
- change in HDL concentration in serum(4 weeks)
- change in LDL concentration in serum(4 weeks)
- change in protein-c reactive concentration in serum(4 weeks)
- change in Plasma MDA concentrations (malondialdehyde)(4 weeks)
- change in tryglicerides concentration in serum(4 weeks)
研究者
Janaina Donadio
Principal Investigator
University of Sao Paulo