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临床试验/NCT02099578
NCT02099578已完成不适用

Daily Incorporation of Strawberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Prehypertension

Florida State University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年2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
60
试验地点
2
主要终点
Blood Pressure

研究概览

简要总结

Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major modifiable risk factor for CVD and approximately 60% of adults in the US are pre-hypertensive and hypertensive. In addition, the prevalence of hypertension is associated with aging in both genders; however, the increase in blood pressure (BP) in women after menopause exceeds that of men.

The development of effective and safe strategies to improve vascular function is of significance as it can have a great impact on quality of life, productivity and economic burden for the affected populations. One such alternative would be to introduce into the diet food sources that are rich in naturally occurring bioactive compounds. Thus, the long-term goal of the investigators is to provide feasible and effective dietary ways for postmenopausal women to improve their vascular function and quality of life.

Strawberries are a rich source of bioactive compounds and its total antioxidant content ranks third among all fruits and vegetables. Hence, the purpose of this study is to bring forth evidence that incorporation of strawberries into the diet will reduce blood pressure and improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women.

Sixty eligible postmenopausal women between the ages of 45 and 65 and a seated BP of ≥ 130/85 mm Hg but ≤ 160/100 mmHg at the screening visit will be randomly assigned to one of three groups:

  1. 25 g freeze-dried strawberry powder;
  2. 50 g freeze-dried strawberry powder; or
  3. placebo powder. Participants will be asked to consume the supplements for 8-weeks. Medical history, medication use, dietary intake, and physical activity will be assessed at 0-, 4-, and 8-weeks followed by blood draw. Serum levels of markers of cardiovascular function as well as oxidative stress and inflammation will be measured.

The investigators hypothesize that regular consumption of strawberry will improve cardiovascular function, decrease BP and blood markers of oxidative stress as well as inflammation. Investigators also expect the findings of this study to provide a foundation for further studies to examine the effects of long-term incorporation of strawberry into the diet and the integrity of cardiovascular system.

研究设计

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

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal women (1 to 10 years after natural menopause or bilateral oophorectomy)
  • 45-65 years of age
  • Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/100 mm Hg
  • BMI > 25 but < 40 kg/m2

排除标准

  • Seated blood pressure ≤ 129/84 or ≥160/101 mmHg
  • Type I Diabetes
  • Cardiovascular disease
  • Active cancer
  • Thyroid disease
  • Kidney disease
  • Liver disease
  • Pancreatic disease
  • Enrollment in a weight loss program
  • Heavy smokers (>20 cigarettes per day)

结局指标

主要结局

Blood Pressure

时间窗: 8 weeks

By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

次要结局

  • Arterial Stiffness(8 weeks)
  • Oxidative Stress(8 weeks)
  • Endothelial function(8 weeks)
  • Inflammation(8 weeks)

研究者

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

Bahram Arjmandi

Margaret A. Sitton Professor and Director of the Center for Advancing Exercise and Nutrition Research on Aging

Florida State University

研究点 (2)

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