NCT01463085Unknown不适用
A Randomized, Controlled, Trial to Assess the Effects of Low-fat Dairy Intake on Endothelial Function and Blood Pressure in Subjects With Pre-hypertension or Stage 1 Hypertension
Dairy Research Institute2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Systolic blood pressure
研究概览
简要总结
The purpose of this study is to determine if increased consumption of low-fat dairy can reduce blood pressure and improve endothelial function in men and women with pre or stage-1 hypertension.
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
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a female or male, 20-69 years of age, inclusive.
- •Subject has a BMI of 18.5 to 39.9 kg/m2, inclusive.
- •Subject has resting blood pressure measurements meeting the criteria for pre-hypertension (SBP = 120 to 139 mm Hg and/or DBP = 80 to 89 mm Hg) or stage 1 hypertension (SBP = 140 to 159 mm Hg or DBP = 90 to 99 mm Hg)
- •Subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part of their normal diet
- •Subject is willing to consume ≤1 serving/d of dairy foods (other than the study products provided) during each treatment phase.
- •Subject is willing to maintain a stable body weight and habitual diet and physical activity patterns throughout the trial, with the exception of specific study instructions related to study product intake, alcohol intake, and physical activity.
排除标准
- •Subject has known coronary heart disease (CHD) or a CHD risk equivalent
- •Subject has a history of any major trauma or major surgical event
- •Subject has digital deformities that would prevent EndoPAT measurements.
- •Subject has used medications known to alter body weight
- •Subject has used medications or dietary supplements that, in the opinion of the Investigator, have strong potential to influence blood pressure or endothelial function
- •Subject has extreme dietary habits (e.g., Atkins diet, very high protein/low carbohydrate).
结局指标
主要结局
Systolic blood pressure
时间窗: 5 weeks
Seated, resting blood pressure and heart rate will be measured by an automated blood pressure measurement device.
次要结局
- Vascular function(5 weeks)
研究者
研究点 (2)
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