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临床试验/NCT02180841
NCT02180841已完成不适用

Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness

Penn State University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年3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
20
试验地点
2
主要终点
HDL function (RCT) as measured by cholesterol efflux.

研究概览

简要总结

The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle size and HDL function), central blood pressure, and indices of arterial stiffness.

详细描述

The investigators propose to conduct a randomized three-period, crossover study to evaluate the effect of soy protein supplementation on HDL function. To ensure that there are no effects of treatment order on outcome measures, subjects will be randomized to a treatment sequence. Healthy males and females (n = 20; 35 to 60 years of age) with systolic blood pressure greater than 120 mm Hg and/or diastolic blood pressure greater than 80 mm Hg will be recruited for this study. Subjects will undergo 3 treatment periods in random order. These treatment periods will include: A) 25 g/d soy protein powder; B) 50 g/d soy protein powder; C) 0 g/d protein powder (control). Each treatment will be provided for 6 weeks separated by a 2-week break between treatment periods. All subjects will be encouraged to maintain body weight and physical activity levels during the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and Female
  • 35-60 years old,with
  • Systolic blood pressure greater than 120 mm Hg
  • Diastolic blood pressure greater than 80 mm Hg
  • BMI within 18-39 kg/m2 ,
  • non smokers with
  • no inflammatory diseases and
  • not taking medication for high cholesterol, blood pressure, or glucose control

排除标准

  • Under 35 years of age or over 60 years old
  • Systolic blood pressure <120 or Diastolic blood pressure <80
  • inflammatory disease
  • BMI outside of 18-39kg/m2 range
  • taking medication
  • refusal to discontinue any other supplement use

结局指标

主要结局

HDL function (RCT) as measured by cholesterol efflux.

时间窗: Week 22

End of treatment 3

次要结局

  • HDL particle size(Week 22)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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