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临床试验/NL-OMON36657
NL-OMON36657已完成不适用

The effects of plant sterol and stanol esters on serum oxyphytosterol concentrations in healthy human subjects - Phytosterols and oxyphytosterol concentrations

niversiteit Maastricht0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • aged between 18 and 70 years
  • Body Mass Index (BMI) between 20-30 kg/m2
  • mean serum total cholesterol < 7.8 mmol/L
  • mean serum triacylglycerol < 3.0 mmol/L
  • mean plasma glucose < 6.1 mmol/L

排除标准

  • - unstable body weight (weight gain or loss > 3 kg in the past two months)
  • - active cardiovascular diseases like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebral vascular incident)
  • - severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis)
  • - indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
  • - use of medication such as corticosteroids, diuretics or lipid lowering therapy
  • - abuse of drug or alcohol (>21 units per week)
  • - not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in sterol or stanol esters 4 weeks before the start of the study (wash-in period)
  • - use of an investigational product within another biomedical study within the previous month
  • - pregnant or breast-feeding women
  • - not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
  • - current smoker
  • - anemia. with a Hb-level below 7.5 mmol/L for men and below 7.0 mmol/L for women, as indicated by the blood bank of Maastricht

研究者

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