An Interventional Study for the Beneficial Effects of Probiotics on Cardio-metabolic Health in Chinese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Flow-mediated slowing (FMS)
研究概览
简要总结
Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms. This trial aims to examine its protective effect in humans.
详细描述
Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids.
However, whether administration of probiotics also has a protective effect in subjects with metabolic syndrome (MetS), who are at high risk for developing atherosclerosis, remain unknown.
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)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Local residents aged between 30-60 years old;
- •Stable weight (<5% weight change over last 3 months);
- •Central obesity defined as waist circumference ≥90 cm in males or ≥80 cm in females, Plus any two of the following four conditions i) Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L); ii) Reduced HDL cholesterol: serum HDL-c <40 mg/dL (1.03 mmol/L) in males or <50 mg/dL (1.29 mmol/L) in females; iii) Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; iv) Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L)
- •Absence of any systemic, cardiovascular diseases, as well as infections within the previous month;
- •Absence of any diet or medication that might interfere with metabolic homoeostasis and gut microbiota, especially antibiotics and probiotics 4 weeks before recruitment.
排除标准
- •Acute illness or current evidence of acute or chronic inflammatory of infective diseases;
- •Participation in regular diet 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
Flow-mediated slowing (FMS)
时间窗: from baseline to 12 weeks after intervention
FMS is a simple test for endothelial functions measured by Vicorder. In patients whose endothelial function or flow-mediated vasodilation are compromised, the FMS is substantially reduced.
次要结局
- microbial metabolites(from baseline to 12 weeks after intervention)
- Insulin sensitivity(from baseline to 12 weeks after intervention)
- gut microbiota(from baseline to 12 weeks after intervention)
- Metabolic Syndrome Severity Z Score (MetZ score)(from baseline to 12 weeks after intervention)
- Lipid profiles(from baseline to 12 weeks after intervention)
- Blood pressure(from baseline to 12 weeks after intervention)
研究者
Min Xia
Professor
Sun Yat-sen University