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临床试验/NCT00175097
NCT00175097已完成不适用

Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects.

Tufts University4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2001年6月最近更新:
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
4
主要终点
Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase

研究概览

简要总结

To evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects.

详细描述

Recent data suggests that the magnitude of the effect of soy protein on lipid and lipoprotein levels is variable and less dramatic than originally reported. This discordance might be attributable to the forms of soy protein used, as well as subtle unrecognized shifts in the fatty acid, cholesterol and fiber content of the diets.The aim of the present investigation is to assess the effects of different forms of soybeans (whole bean and products made thereof), products derived from soy flour (textured soy protein) and products made from a soybean extract (i.e. tofu, yogurt) relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects. The intent is to isolate any potential impact of processing on the plasma lipid lowering efficacy of the soy product or soy protein relative to animal protein.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Plasma LDL-C >120mg/dL, Free from chronic illness, Not taking medications known to affect lipid metabolism (lipid lowering drugs, beta-blockers, fish-oil capsules, cis-retinoic acid, ascorbic acid, vitamin E, diuretics or hormones), Post-menopausal women.

排除标准

  • Soy allergy, Smokers, Consuming >2 alcoholic drinks per day, Pre-menopausal women.

结局指标

主要结局

Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase

时间窗: 24 weeks

Vascular endothelial function; end of each dietary phase

时间窗: 24 weeks

Susceptibility of LDL to oxidation; end of each dietary phase

时间窗: 24 weeks

C-reactive protein; end of each dietary phase

时间窗: 24 weeks

次要结局

  • Endogenous cholesterol synthesis; end of each dietary phase(24 weeks)
  • Endogenous triglyceride synthesis; end of each dietary phase(24 weeks)
  • Plasma and Urinary Isoflavone levels; end of each dietary phase(24 weeks)
  • Genotyping of candidate genes involved in the variability observed in response to dietary modification(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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