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临床试验/NCT01304992
NCT01304992已完成不适用

Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects

University of Jena2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2011年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
Cholesterol metabolism

研究概览

简要总结

The objective of the study is to determine the efficacy of lupin protein drinks (Lupinus angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the metabolism of proteins, lipids and cholesterol will be evaluated.

详细描述

Based on the preliminary finding that a daily dosage of 35 g lupin protein is capable to affect plasma lipids positively, the physiological effects of two different daily lupin protein dosages will be investigated in two separate study groups (group A: 25 g protein/day; group B: 40 g protein/day). Both study groups undergo double-blinded and controlled study conditions in a cross-over design.

In each of the two study groups 35 volunteers with hypercholesterolemia will be allocated to one of two randomization groups: After a 1-week run-in period (baseline), half of the 35 participants of each study group will consume drinks with lupin protein in the respective amount (25 g or 40 g protein/day) over a period of eight weeks, the other half will receive the analogue amount of milk protein as well incorporated in a drink serving as control. After a wash-out period of four weeks, the protein source will be crossed within the two study groups for a second intervention period of eight weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate hypercholesterolemia (total cholesterol >5,2 mmol/L)
  • Age: 18-80 years old

排除标准

  • Intake of lipid-lowering pharmaceuticals
  • Allergy against legumes or milk protein
  • Intolerance against milk
  • Pregnancy, lactation
  • Chronic bowel disease

结局指标

主要结局

Cholesterol metabolism

时间窗: After 0, 4, 8, 12, 16 and 20 weeks

Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles)

次要结局

  • Protein metabolism(After 0, 8, 12 and 20 weeks)
  • Body composition (body status)(After 0, 8, 12 and 20 weeks)
  • High-sensitive CRP(After 0, 8, 12 and 20 weeks)
  • Fasting glucose(After 0, 8, 12 and 20 weeks)

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

Gerhard Jahreis

Prof. Dr. habil.

University of Jena

研究点 (2)

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