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临床试验/NCT01224249
NCT01224249已完成1 期

Selenium Status Measured in Blood After a Higher Intake of Fish and Shellfish - a Randomized Dietary Intervention Study

Danish Cancer Society1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2010年8月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
102
试验地点
1
主要终点
Selenium concentration in whole blood

研究概览

简要总结

The primary aim of this study is to investigate, whether higher intake of selenium rich food items such as fish and shellfish, is associated with higher selenium blood levels.

The secondary aim is to investigate the uptake of selenium from fish and shellfish and the incorporation of selenium from those foods into proteins in the human body. Furthermore, the impact of the natural variation in the genes that are responsible for the accumulation of selenium in the proteins will be investigated.

详细描述

Selenium is an essential trace element that is incorporated into proteins in the human body and it hereby plays a major role in several important cellular processes. Previous studies have indicated that the selenium status of the Danish population is below the levels required to optimize the suggested protective effects of selenium towards major diseases including cancer. In Denmark, important natural sources of selenium are fish and shellfish.

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
None

入排标准

年龄范围
50 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •men and women
  • •50-74 years
  • •BMI 18.5-28 kg/m2
  • •non-smokers

排除标准

  • •strenuous exercise > 10 h/week
  • •excessive intake of alcohol
  • •frequent intake of fish and shellfish > 200-300 g/week
  • •intake of dietary supplements 3 months before or during the study
  • •frequent use of medication except antihypertensive medicine, cholesterol lowering medicine and hormone replacement medicine
  • •simultaneous participation in other research projects
  • •cancer diagnosis within the past 5 years
  • •severe chronic diseases

研究组 & 干预措施

Fish and shellfish

Active Comparator

干预措施: Fish and shellfish (Dietary Supplement)

Control

No Intervention

Assessment only

结局指标

主要结局

Selenium concentration in whole blood

时间窗: Measured after 6 months of intervention

Selenium concentration in whole blood

时间窗: Measured at baseline

Selenium concentration in whole blood

时间窗: Measured after 3 months of intervention

次要结局

  • Selenoprotein P in plasma(Measured after 6 months of intervention)
  • Genetic polymorphisms in the selenoprotein P gene(Measured after 6 months of intervention)
  • Heavy metals in whole blood (lead, cadmium, and mercury)(Measured after 6 months of intervention)
  • Blood pressure(Measured after 6 months of intervention)
  • Anthropometry (weight, height, waist, and hip circumference)(Measured after 6 months of intervention)
  • Selenoprotein P in plasma(Measured at baseline)
  • Selenoprotein P in plasma(Measured after 3 months of intervention)
  • Genetic polymorphisms in the selenoprotein P gene(Measured at baseline)
  • Genetic polymorphisms in the selenoprotein P gene(Measured after 3 months of intervention)
  • Heavy metals in whole blood (lead, cadmium, and mercury)(Measured at baseline)
  • Heavy metals in whole blood (lead, cadmium, and mercury)(Measured after 3 months of intervention)
  • Blood pressure(Measured at baseline)
  • Blood pressure(Measured after 3 months of intervention)
  • Anthropometry (weight, height, waist, and hip circumference)(Measured at baseline)
  • Anthropometry (weight, height, waist, and hip circumference)(Measured after 3 months of intervention)

研究者

申办方类型
Other

研究点 (1)

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