Effect of Prebiotics on Blood Pressure Management
2022年5月3日 更新者：Min Xia、Sun Yat-sen University
An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk
This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood pressure, gut microbiota and cardiovascular risk fators in subjects with hypertention.
研究概览
详细说明
Highland barley β-glucan belongs to the group of prebiotics and has been found to be associated with multiple health benefits.
However, its protective role in subjects with hypertension are remain unclear.
This study aims to examine the effect of 12-week prebiotics supplementation on blood pressure management in subjects with hypertension.
By understanding the mechanism by which prebiotics exert the beneficial effects, we can better control the rising prevalence of hypertension, which is a major risk factor for cardiovascular diseases.
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Min Xia, PhD
- 电话号码：+86 20 87332433
- 邮箱：xiamin@mail.sysu.edu.cn
学习地点
-
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Guangdong
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Guangzhou、Guangdong、中国、510080
- Sun Yat-sen University
-
接触：
- Min Xia, PhD
- 电话号码：+86-2087332433
- 邮箱：xiamin@mail.sysu.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age:30-65 years old
- Newly diagnosed hypertension did not use antihypertensive drugs OR Systolic blood pressure ≥140mmHg on the physical examination OR Diastolic blood pressure ≥90mmHg on the physical examination.
- BMI≥18 kg/m2
Exclusion Criteria:
- Receiving or have been treated with antihypertensive drugs.
- Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke.
- Severe liver or renal insufficiency (alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase is greater than 3 times the upper limit of normal OR GFR<30ml/min/1.73m2).
- Autoimmune diseases or thyroid diseases.
- Women who are pregnant, nursing, or prepare to give birth during the trail.
- Malignant disease, infectious disease, inflammatory disease and advanced liver disease.
- Mental or intellectual abnormalities, unable to sign informed consent.
- Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit.
- Received antibiotics, probiotics within 3 months before screening visit or throughout the trail.
- Major operations were performed within six months of screening visit, or will be made during the trial.
- Alcohol abuse (alcohol intake>60g/d for male and alcohol intake>40g/d for female)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Highland barley β-glucan group
Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 12 weeks followed by comprehensive physical and clinical examinations.
|
100 mL oral liquid mainly containing highland barley β-glucan once daily for 12 weeks
|
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安慰剂比较：Placebo group
Participants will be given oral liquids mainly containing Corn starch once daily for 12 weeks followed by comprehensive physical and clinical examinations.
|
与青稞β-葡聚糖补充剂具有相似外观和味道的安慰剂
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
changes of systolic blood pressure
大体时间：baseline and 12 weeks
|
changes of systolic blood pressure
|
baseline and 12 weeks
|
|
changes of diastolic blood pressure
大体时间：baseline and 12 weeks
|
changes of diastolic blood pressure
|
baseline and 12 weeks
|
|
changes of gut microbiota
大体时间：baseline and 12 weeks
|
changes of gut microbiota by metagenomics
|
baseline and 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
gut microbiota
大体时间：baseline and 12 weeks
|
changes of gut microbiota by metagenomics
|
baseline and 12 weeks
|
|
pulse wave velocity
大体时间：baseline and 12 weeks
|
changes of pulse wave velocity by VP-1000plus from Omron
|
baseline and 12 weeks
|
|
ankle Brachial Index
大体时间：baseline and 12 weeks
|
changes of ankle Brachial Index by VP-1000plus from Omron
|
baseline and 12 weeks
|
|
microbial metabolite
大体时间：baseline and 12 weeks
|
changes of microbial metabolite by untargeted metabolomics
|
baseline and 12 weeks
|
|
central aortic pressure
大体时间：baseline and 12 weeks
|
changes of central aortic pressure by VICORDER Complete Vascular Laboratory
|
baseline and 12 weeks
|
|
flow-mediated dilation
大体时间：baseline and 12 weeks
|
changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory
|
baseline and 12 weeks
|
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carotid-femoral pulse wave velocity
大体时间：baseline and 12 weeks
|
changes of carotid-femoral pulse wave velocity by VICORDER Complete Vascular Laboratory
|
baseline and 12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Min Xia, PhD、Sun Yat-sen University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年10月17日
初级完成 (预期的)
2023年12月31日
研究完成 (预期的)
2030年12月31日
研究注册日期
首次提交
2022年5月3日
首先提交符合 QC 标准的
2022年5月3日
首次发布 (实际的)
2022年5月6日
研究记录更新
最后更新发布 (实际的)
2022年5月6日
上次提交的符合 QC 标准的更新
2022年5月3日
最后验证
2022年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.