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临床试验/NCT03716960
NCT03716960已完成不适用

The Effects of Pumpkin Seed Oil Supplementation on Vascular Hemodynamics, Stiffness and Cardiac Autonomic Function in Postmenopausal Women.

Marymount University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年9月1日最近更新:
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
23
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

Postmenopausal women have a higher prevalence of cardiovascular (CV) disease than age-match men. Growing evidence from rat studies have demonstrated CV-protective effects of pumpkin seed oil (PSO).

The investigators hypothesis is that PSO would improve CV health in postmenopausal women.

详细描述

The purpose of the study is to examine the effects of 6 weeks of PSO on arterial and autonomic function in postmenopausal women. Specific aims of the study are to:

To investigate the extent to which PSO will improve cardiovascular disease risk factors by assessing arterial stiffness, aortic BP and wave reflection, and autonomic function (heart rate variability).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

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

  • 45 to 65 years of age
  • At least 1 year after menopause
  • BMI <39.9
  • Sedentary or low active (less than 2 hr per wk)

排除标准

  • known heart disease
  • peripheral vascular disease
  • diabetes, body mass index
  • BMI> 40 kg/m2
  • other chronic diseases
  • taking medications (e.g., hormone replacement therapy, beta blockers, calcium channel blockers, antidepressants and stimulants) that could affect the outcome variables
  • history of steady exercise or received exercise training and dietary changes in the last year

研究组 & 干预措施

Pumpkin Seed Oil

Experimental

This arm involved 6 weeks of PSO consumption. Subject were supplemented with 3 g/day of PSO which was ingested in the form of 1g capsules with each main meal of the day (breakfast, lunch and dinner). Likewise,

干预措施: Pumpkin Seed Oil (Other)

Placebo

Placebo Comparator

This arm involved 6 weeks of placebo consumption. Subject consumed 1 capsule of maltodextrin with each main meal of the day to match the dose and number of capsules ingested daily by the PSO group.

干预措施: Placebo (Other)

结局指标

主要结局

Blood pressure

时间窗: 6 weeks

Non-invasive measures of brachial and aortic blood pressure

Pressure Wave Reflection

时间窗: 6 weeks

Using the augmentation index

Arterial Stiffness

时间窗: 6 weeks

Using the stiffness index

Heart rate variability

时间窗: 6 weeks

R-R intervals were collected during 6 min using a validated wireless monitor (Polar 800CX; Polar Electro OY, Kempele, Finland) via a chest strap interfaced with a PC. All R-R intervals were inspected for artifacts and premature beats.

次要结局

未报告次要终点

研究者

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

Alexei Wong

Assistant Professor

Marymount University

研究点 (2)

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