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临床试验/NCT01315964
NCT01315964已完成不适用

Effects of Dietary Plant Stanol Esters of Blood Flow Among Healthy Adult Human Subject. The BLOOD FLOW -Study

University of Helsinki1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Structure and function of the arterial wall

研究概览

简要总结

Plant stanol esters as part of daily diet can decrease serum level of LDL-cholesterol up to 10%. This decrease diminishes the risk of development of premature atherosclerosis and it´s complications (e.g., acute myocardial infarction) in adult human subjects.

The purpose of the present study is to evaluate among healthy human subjects (N=100) effects of plant stanol esters (3 grams/day for 6 months) as part of daily diet in margarine on arterial endothelial cells, arterial stiffness, autonomic innervation of the arteries, arterial blood flow and serum fats. The non-invasive arterial measurements (VaSera®, EndoPat® and WinCRPS®) are performed and blood samples are taken at the beginning and at the end of the 6-month-long study period. Also questionnaires concerning healthy, and life and dietary habits are fulfilled. Dietary records (twice for a 3-day-period) are done.

Hypothesis of the study is that a dietary serum cholesterol lowering intervention has beneficial influence on the early prognostic markers of premature atherosclerosis.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healthy human subjects

排除标准

  • •abnormal liver, kidney and thyroid function
  • •unstable myocardial disease
  • •inflammatory bowel disease
  • •alcohol abuse
  • •pregnancy
  • •any lipid-lowering medication

研究组 & 干预措施

plant stanol ester

Active Comparator

3 grams of plant stanol esters per day in a margarine product as part of daily diet for 6 months

干预措施: plant stanol ester (Dietary Supplement)

Placebo

Placebo Comparator

a margarine product as part of daily diet, which is not containing plant stanol esters

干预措施: plant stanol ester (Dietary Supplement)

结局指标

主要结局

Structure and function of the arterial wall

时间窗: 6 months

次要结局

  • serum composition of fats(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Markku Nissinen

MD PhD

University of Helsinki

研究点 (1)

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