Role of Probiotics in the Prevention of Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- changes of systolic blood pressure
研究概览
简要总结
Dysbiosis of gut microbiota has been reported to be involved in the development and progression of hypertension in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate hypertension in adults remain obscure.
详细描述
Probiotics are live microorganisms that have been associated with multiple health benefits. However, its protective role in adults has long been controversial. This study aims to examine the effect of 12-week probiotics supplementation on the prevention of hypertension in Chinese adults. By understanding the mechanisms by which probiotics exert this beneficial effects, we can better control the rising prevalence of hypertension, which is a major risk factor for cardiovascular diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible subjects include men and women 18 to 75 years of age with pre-hypertension who has a systemic blood between 120 and 139 mmHg and/ or a diastolic blood pressure between 80 and 80 mmHg;
- •Absence of any diet, dietary supplement and medications that might interfere with blood pressure and gut microbiota, especially antibiotics and probiotics.
排除标准
- •Any other systemic, metabolic and cardiovascular or cerebrovascular diseases;
- •Type 1 diabetes, type 2 diabetes treated with insulin or other medications;
- •Acute illness or current evidence of acute or chronic inflammatory or infective diseases;
- •Participation in any diet or lifestyle program more than 2 times per week in the latest 3 months prior to recruitment;
- •Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.
结局指标
主要结局
changes of systolic blood pressure
时间窗: baseline, 4 weeks, 8 weeks and 12 weeks
changes of systolic blood pressure
changes of gut microbiota
时间窗: baseline, 4 weeks, 8 weeks and 12 weeks
changes of gut microbiota by metagenomics
changes of diastolic blood pressure
时间窗: baseline, 4 weeks, 8 weeks and 12 weeks
changes of diastolic blood pressure
次要结局
- changes of pulse wave velocity(baseline and after 12-week intervention)
- changes of ankle brachial index(baseline and after 12-week intervention)
- changes of microbial metabolite(baseline and after 12-week intervention)
研究者
Min Xia
Professor
Sun Yat-sen University