Role of Probiotics in the Management of Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Triglyceride
研究概览
简要总结
Dysbiosis of gut microbiota has been reported to be involved in the development of hypercholesterolemia in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate dyslipidemia 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 lipid management in Chinese adults. By understanding the mechanism by which probiotics exert the beneficial effects, we can better control the rising prevalence of hypercholesterolemia, 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 primary hypercholesterolemia who has a total cholesterol level of 5.18 mmol/L or higher and/ or an LDL cholesterol level of 2.59 mmol/L or higher;
- •Absence of any diet, dietary supplement and medication that might interfere with lipid homoeostasis and gut microbiota, especially antibiotics and probiotics.
排除标准
- •Triglyceride levels higher than 3.95 mmol/L, or 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
Triglyceride
时间窗: baseline, 4 weeks, 8 weeks and 12 weeks
changes of triglyceride levels in plasma by automatic biochemical analyzer
Total cholesterol
时间窗: baseline, 4 weeks, 8 weeks and 12 weeks
changes of total cholesterol levels in plasma by automatic biochemical analyzer
LDL-cholesterol
时间窗: baseline, 4 weeks, 8 weeks and 12 weeks
changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer
gut microbiota
时间窗: baseline, 4 week, 8 weeks and 12 weeks
changes of gut microbiota by metagenomics
non HDL-cholesterol
时间窗: baseline, 4 weeks, 8 weeks and 12 weeks
changes of non HDL-cholesterol levels in plasma
次要结局
- blood pressure(baseline, 4 week, 8 week and 12 weeks)
- pulse wave velocity(baseline and after 12-week intervention)
- microbial metabolite(baseline and after 12-week intervention)
- ankle Brachial Index(baseline and after 12-week intervention)
研究者
Min Xia
Professor
Sun Yat-sen University