Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects
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
- 是
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
Gerhard Jahreis
Prof. Dr. habil.
University of Jena
