Effect of Soy on HDL-C Function, Central Blood Pressure, and Arterial Stiffness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Control
Control powder
干预措施: Placebo (Dietary Supplement)
Control
Control powder
干预措施: Soy Protein Powder (50g/d) (Dietary Supplement)
Soy 25g
Soy protein powder (25g/day)
干预措施: Soy Protein Powder (25g/d) (Dietary Supplement)
Soy 25g
Soy protein powder (25g/day)
干预措施: Placebo (Dietary Supplement)
Soy 25g
Soy protein powder (25g/day)
干预措施: Soy Protein Powder (50g/d) (Dietary Supplement)
Soy 50g
Soy protein powder 50 g/day
干预措施: Soy Protein Powder (25g/d) (Dietary Supplement)
Soy 50g
Soy protein powder 50 g/day
干预措施: Placebo (Dietary Supplement)
Soy 50g
Soy protein powder 50 g/day
干预措施: Soy Protein Powder (50g/d) (Dietary Supplement)
Control
Control powder
干预措施: Soy Protein Powder (25g/d) (Dietary Supplement)
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
HDL function (RCT) as measured by cholesterol efflux.
时间窗: Week 6
End of treatment 1
HDL function (RCT) as measured by cholesterol efflux.
时间窗: Week 14
End of treatment 2
HDL function (RCT) as measured by cholesterol efflux.
时间窗: Baseline
Prior to start of intervention
次要结局
- HDL particle size(Week 22)
- HDL particle size(Baseline)
- HDL particle size(Week 6)
- HDL particle size(Week 14)