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临床试验/NCT03545555
NCT03545555Unknown不适用

Investigations on the Effect of Kale on the Lipid Status (Untersuchungen Zum Einfluss Von Grünkohl Auf Den Lipidstatus)

University of Jena2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Change of lipid status parameters

研究概览

简要总结

This intervention study investigates the effects of various kale preparations (dietary supplements) on lipid status parameters. Within the study period of 8 weeks, three blood withdrawals are planned (week 0, 4 and 8) for the volunteers. Lipid status parameters (total cholesterol, HDL cholesterol, LDL cholesterol, triacylglycerides) will be determined in blood. There is a correlation between contents of LDL cholesterol, total cholesterol and triacylglycerides and the risk for cardiovascular diseases (CVD). In contrast, a high content of HDL cholesterol is correlated with a lower risk for CVD. In addition, the contents of apolipoprotein A1 and apolipoprotein B will be analysed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • total cholesterol > 200 mg/dl

排除标准

  • LDL cholesterol < 130 mg/dl
  • medication to lower blood lipids
  • genetically based hypercholesterolemia

研究组 & 干预措施

Kale Powder

Experimental

5 capsules with kale preparation "kale powder" per day for 8 weeks

干预措施: Kale Preparation "Kale Powder" (Dietary Supplement)

Kale Extract

Experimental

5 capsules with kale preparation "kale extract" per day for 8 weeks

干预措施: Kale Preparation "Kale Extract" (Dietary Supplement)

Flavonoid Extract

Experimental

5 capsules with kale preparation "flavonoid extract" (from kale) per day for 8 weeks

干预措施: Kale Preparation "Flavonoid Extract" (Dietary Supplement)

Placebo

Placebo Comparator

5 capsules with "placebo" per day for 8 weeks

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Change of lipid status parameters

时间窗: weeks 0, 4 and 8

total cholesterol, HDL cholesterol, LDL cholesterol

次要结局

  • Change of apolipoproteins(weeks 0, 4 and 8)
  • Change of antioxidant capacity(weeks 0, 4 and 8)

研究者

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Volker Boehm

Head of Bioactive Plant Products Research Group

University of Jena

研究点 (2)

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