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临床试验/NCT01598649
NCT01598649已完成不适用

Influence of Intervention With Lupin Protein-enriched Foods on Cardiovascular Risk Factors in Hypercholesterolemic Subjects

University of Jena1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2012年6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
72
试验地点
1
主要终点
Changes in cholesterol metabolism

研究概览

简要总结

The objective of the study is to elucidate the effects of lupin protein (Lupinus angustifolius Boregine) as part of a mixed diet on cardiovascular risk factors and to clarify the role of arginine, one of the most abundant amino acids in lupin protein.

详细描述

The study is based on a previous finding that a daily dosage of 25 g lupin protein isolate, administered as protein drinks, is capable to influence the plasma lipids positively.

Consequently, the physiological effects of a mixed diet containing 25 g lupin protein isolate per day will be investigated compared to 1) a diet containing 25 g of milk protein as well as to 2) a diet with 25 g milk protein and additionally the amino acid arginine supplemented daily.

A double-blinded, controlled, randomized cross-over trial will be performed. Altogether 75 volunteers with hypercholesterolemia will be divided into three groups of 25 subjects each. After a run-in period (baseline), the first group will consume foods with lupin protein isolate (group A), the second group will receive the same foods with milk protein isolate (group B) and the third group will consume the foods with milk protein and 1,6 g arginine per day over a period of four weeks. After a wash-out period of six weeks, the diet will be crossed within the three groups for a second intervention period of four weeks. After another wash-out period, diet will be crossed within the three groups once again.

Arginine will be provided as capsule (1,6 g per day = four capsules per day) in one of the two groups receiving foods with milk protein. In the other groups (receiving foods with lupin protein or milk protein only) four placebo capsules will be served, containing mannitol.

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
20 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: 20-80 years

排除标准

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

结局指标

主要结局

Changes in cholesterol metabolism

时间窗: After 0, 4, 10, 14, 20, and 24 weeks

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

次要结局

  • Changes in protein metabolism(After 0,4, 10, 14, 20, and 24 weeks)
  • Changes in body composition (body status)(After 0, 4, 10, 14, 20, and 24 weeks)
  • Changes in high-sensitive CRP(After 0, 4, 10, 14, 20, and 24 weeks)
  • Changes in parameter of diabetes mellitus(After 0, 4, 10, 14, 20, and 24 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 (1)

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