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临床试验/NCT00175084
NCT00175084已完成不适用

Effect of Dietary Amino Acid Profile on Lipoprotein Metabolism, Vascular Reactivity and Inflammatory Markers

Tufts University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Serum lipid and lipoprotein concentrations, endothelial function, blood pressure, indicators of nitrous oxide end products, homocysteine, inflammation and oxidation markers.

研究概览

简要总结

The aim of this study is to explore the significance of the Lys:Arg ratio on responses of lipids and lipoprotein concentrations to dietary proteins and to evaluate the effects of dietary Lys:Arg on cardiovascular disease risk factors and endothelial function.

详细描述

Findings from early studies in a variety of experimental models of atherosclerosis on the effect of dietary protein suggested that proteins from vegetable sources are less cholesterolemic and atherogenic than proteins from animal sources. Throughout the later part of the 20th century there has been sporadic interest in the effect of protein type and amino acid profiles on blood lipid concentrations and atherosclerosis. A major focus for this evaluation has been to compare proteins based on their amino acid profile, often expressed as lysine (Lys) to arginine (Arg) ratio (Lys:Arg). While animal studies have provided important information regarding the significance of the Lys:Arg in determining the cholesterolemic response to a dietary protein, interpretation of these data must be done with caution since most of the studies have been conducted in animal models that have a different lipoprotein distribution and metabolism than humans. Moreover, the mechanistic insights of this response are yet to be determined. While the favorable effects of Arg on endothelial function appear to be consistent when Arg is administered using a supplement, the effects of dietary Arg naturally present in protein rich foods has yet to be determined. The aim of this proposal is to explore the significance of the Lys:Arg ratio on responses of lipids and lipoprotein concentrations to dietary proteins and to evaluate the effects of dietary Lys:Arg on cardiovascular disease risk factors and endothelial function.

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
Single (Investigator)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 50-85 years
  • LDL-C concentrations >120 mg/dL

排除标准

  • Use of medications known to affect lipid metabolism
  • Established cardiovascular disease
  • Renal disease
  • Liver disease
  • Thyroid disease unless controlled with medication for at least 6 months
  • Type I and II diabetes
  • Irritable bowel syndrome
  • Chronic use of prescription anti-inflammatory medications
  • Alcohol intake >7 alcoholic drinks per week
  • Unwillingness to maintain body weight during participation in the study
  • triglyceride (TG) > 400 mg/dL
  • Unwillingness to adhere to diet and study protocol
  • Weight gain or loss of more than 15 lb within 6 months prior to enrollment

结局指标

主要结局

Serum lipid and lipoprotein concentrations, endothelial function, blood pressure, indicators of nitrous oxide end products, homocysteine, inflammation and oxidation markers.

时间窗: 5 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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