An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- changes of gut microbiota
研究概览
简要总结
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.
详细描述
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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) 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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
changes of gut microbiota
时间窗: baseline and 12 weeks
changes of gut microbiota by metagenomics
changes of systolic blood pressure
时间窗: baseline and 12 weeks
changes of systolic blood pressure
changes of diastolic blood pressure
时间窗: baseline and 12 weeks
changes of diastolic blood pressure
次要结局
- microbial metabolite(baseline and 12 weeks)
- flow-mediated dilation(baseline and 12 weeks)
- central aortic pressure(baseline and 12 weeks)
- gut microbiota(baseline and 12 weeks)
- carotid-femoral pulse wave velocity(baseline and 12 weeks)
- pulse wave velocity(baseline and 12 weeks)
- ankle Brachial Index(baseline and 12 weeks)
研究者
Min Xia
Professor
Sun Yat-sen University