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临床试验/NCT04016090
NCT04016090已完成不适用

An Evaluation of Folic Acid to Improve Endothelial Sensitivity to Shear Stress in Post-menopausal Women.

Montreal Heart Institute2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Endothelial sensitivity to shear rate

研究概览

简要总结

The purpose of this study is to evaluate if folic acid improves endothelial sensitivity to shear stress in post-menopausal women.

详细描述

Cardiovascular diseases (CVD) have remained the leading cause of death globally for the last 15 years. Considering that advancing age is the primary risk factor for CVD, an increasingly aging population is expected to result in unprecedented levels of CVD. It therefore remains crucial to develop effective prevention or treatment strategies to reduce the impending health and economic burden of CVD.

Exercise is arguably the best intervention for the prevention and/or treatment of CVD. A key adaptation underlying the cardiovascular benefits of exercise is to offset and reverse age-related reductions in vascular function. Studies have demonstrated, at least in men, that active older adults demonstrate preserved vascular function relative to their sedentary peers and that exercise training interventions improve vascular function in previously sedentary older adults. However, these studies have almost exclusively been performed in men. In contrast, the few studies performed in older women consistently demonstrate that active women do not demonstrate preserved vascular function relative to their sedentary peers and that exercise training interventions do not improve vascular function in previously sedentary women. This observation has been attributed to the loss of oestrogens that accompanies menopause. Although the mechanisms have not been fully elicited, it is possible that the loss of oestrogens desensitizes the endothelium to the physiological stimuli that result in improved vascular function with exercise training. Indeed, exercise improves vascular function in previously sedentary older women when it is combined with oestrogen replacement. Nevertheless, chronic oestrogen replacement therapy is not a viable intervention as it is associated with an increased risk of breast cancer. Alternative solutions to restore the beneficial effects of exercise on vascular function in post-menopausal women are thus urgently needed.

The overall objective of this project is to determine if folic acid, an over-the-counter supplement that has been shown to provide beneficial vascular adaptations, can be used to improve vascular function in post-menopausal women. It is hypothesized that folic acid will improve blood vessel function in post-menopausal women and age-matched males.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • ≥ 1-year amenorrhea
  • Body mass index ≤ 30 kg/m2
  • Resting blood pressure < 140 / < 90 mmHg
  • Non-smoker (≥ 1-year)

排除标准

  • Diagnosis of cardiac, vascular, respiratory, neurological or metabolic disease and/or a prescription of medications for the treatment of such diseases.
  • For female participants, hormonal replacement therapy within 1 year of enrolment in the study.
  • For female participants, having undergone an ovariectomy.

结局指标

主要结局

Endothelial sensitivity to shear rate

时间窗: Measured 2 hours after placebo or folic acid consumption

Change in brachial artery diameter for given levels of shear rate during rhythmic handgrip exercise

次要结局

  • Neurovascular transduction(Measured 2 hours after placebo or folic acid consumption)

研究者

发起方
Montreal Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Gagnon

Principal Investigator

Montreal Heart Institute

研究点 (2)

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