The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow, Cognitive Function and Other Hemodynamic Outcomes in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline endothelial dependent microvascular function as laser Doppler imaging (LDI) with iontophoresis
研究概览
简要总结
Cardiovascular disease (CVD) is one of the leading causes of mortality worldwide. Inorganic nitrate found in beetroot and green leafy vegetables has been demonstrated to reduce cardiovascular disease risk factors including reducing blood pressure and the stiffness of blood vessels by increasing levels of a compound called nitric oxide. Much of the research to date has focused on the large blood vessels, and little is known about the impact of inorganic nitrate on smaller blood vessels which could be related to cognitive function.
The majority of beneficial effects with inorganic nitrate have been observed within young healthy populations. However, it is known that after the menopause women are at an increased risk of cardiovascular disease and have reduced levels of nitric oxide in their body; this could also contribute to the cognitive decline also observed post-menopause. This trial will investigate the impact of inorganic nitrate from beetroot juice on the blood flow in small blood vessels and on cognitive function in postmenopausal women. The hypothesis of the study is that the nitrate in beetroot juice will increase circulating nitric oxide that will then increase blood flow in small blood vessels and improve cognitive function.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy post-menopausal women (age over 45)
- •Able to understand information sheet and willing to comply with the study protocol and able to give informed consent
- •Not having menstrual period for 12 months
排除标准
- •Blood pressure <90/60 or > 140/90 mmHg
- •Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, high cholesterol, liver, renal, respiratory or bowel diseases or diabetes or other endocrine disorder
- •Any tobacco and/or nicotine users (or quit within the last 6 months)
- •Current use of antihypertensive medication
- •Alcohol intake > 14 units/week
- •Vigorous exercise > 3 times/ week
- •Antihypertensive medication users
- •People who have had hysterectomy
- •Currently taking hormone replacement therapy or selective oestrogen receptor modulator
研究组 & 干预措施
Nitrate-depleted beetroot juice
干预措施: Nitrate depleted beetroot juice (Dietary Supplement)
结局指标
主要结局
Change from baseline endothelial dependent microvascular function as laser Doppler imaging (LDI) with iontophoresis
时间窗: At baseline (t= 0.5 hours) and t= 3 hours
Measurements will be taken by LDI with iontophoresis of endothelium-dependent (acetylcholine (ACh))
Change from baseline cognitive function. Domain: Executive function 2
时间窗: At baseline (t= 0 hours) and t=2.5 hours
-Stroop Task
Change from baseline endothelial independent microvascular function as laser Doppler imaging (LDI) with iontophoresis
时间窗: At baseline (t= 0.5 hours) and t= 3 hours
Measurements will be taken by LDI of endothelium-independent (sodium nitroprusside (SNP))
Change from baseline cognitive function. Domain: Episodic memory
时间窗: At baseline (t= 0 hours) and t=2.5 hours
-Rey Auditory Verbal Learning Test (RAVLT) task Cognitive domains will be assessed by using the Gorilla online research tools.
Change from baseline cognitive function. Domain: Executive function 1
时间窗: At baseline (t= 0 hours) and t=2.5 hours
-Digit Span Task
次要结局
- Change in blood pressure([Time Frame: At baseline (t= 0 hours) and 15 minute intervals until t= 2.5 hours.])
研究者
Charlotte E Mills
Lecturer, Principal investigator
University of Reading