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临床试验/NCT02397902
NCT02397902已完成不适用

Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Seated blood pressure

研究概览

简要总结

The specific aim of the proposed study is to address the efficacy of conventional full-fat dairy products as part of the normal routine diet for improving vascular function and reducing blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that dietary intervention including whole milk and full-fat milk products will induce significant decreases in systolic blood pressure and arterial stiffness. The investigators also test the hypothesis that the reductions in blood pressure will be associated with the corresponding decreases in arterial stiffness and/or increases in endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity. If our hypotheses are supported by the results, the information could be used as a basis for recommendations for the use of whole milk and full-fat milk products in the secondary prevention of elevated blood pressure and vascular dysfunction.

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
Single (Investigator)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prehypertension or stage-1 hypertension

排除标准

  • Consume > 3 servings of dairy or fruit per day
  • Strenuous physical activity > 3 time per week
  • Lactose intolerance, pregnancy, lactation, and/or alcohol abuse
  • Taking cardiovascular-acting drugs
  • Overt cardiovascular disease, metabolic disease, GI disorders and/or renal disease

研究组 & 干预措施

Dairy

Experimental

Add 4 daily servings of high fat dairy to diet for a period of 4 weeks

干预措施: High fat dairy (Dietary Supplement)

Plant-based

Active Comparator

Add 4 daily servings of fruit to diet and/or plant-based milk, remove all dairy from diet for a period of 4 weeks

干预措施: Plant-based (Dietary Supplement)

结局指标

主要结局

Seated blood pressure

时间窗: 4 weeks

次要结局

  • 24-hour ambulatory blood pressure(4 weeks)
  • Flow mediated dilation(4 weeks)
  • Carotid arterial compliance as measured by arterial pressure and corresponding cross-sectional area by ultrasound(4 weeks)
  • Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen J. Roy

Principal Investigator

University of Texas at Austin

研究点 (2)

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