Effect of Probiotics on Cardiometabolic Health
An Interventional Study for the Beneficial Effects of Probiotics on Cardio-metabolic Health in Chinese Subjects
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510080
- Sun Yat-sen University
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Guangzhou、Guangdong、中国、510080
- Department of Nutrition and Food Hygiene
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
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 |
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实验性的:Probiotics
Subjects are instructed to take one capsule of probiotics daily for a total of 3 months
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During the study period, subjects are instructed to take one capsule of probiotics daily for a total of 3 months.
Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
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安慰剂比较:Placebo Control
Subjects are instructed to take one capsule of placebo daily for a total of 3 months
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During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months.
Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
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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 |
---|---|---|
Flow-mediated slowing (FMS)
大体时间:from baseline to 12 weeks after intervention
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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.
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from baseline to 12 weeks after intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
gut microbiota
大体时间:from baseline to 12 weeks after intervention
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Alterations of the composition of gut microbiota evaluated by metagenomics
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from baseline to 12 weeks after intervention
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microbial metabolites
大体时间:from baseline to 12 weeks after intervention
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alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry
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from baseline to 12 weeks after intervention
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Metabolic Syndrome Severity Z Score (MetZ score)
大体时间:from baseline to 12 weeks after intervention
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MetZ score is an weighted score of the five traditional components of Metabolic syndrome (waist, triglyceride, HDL cholesterol, SBP and fasting glucose).
It's used to evaluate the severity of metabolic disorder, and a higher score indicates a more severe status.
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from baseline to 12 weeks after intervention
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Lipid profiles
大体时间:from baseline to 12 weeks after intervention
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alterations of blood lipids including total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol determined by automatic biochemical analyser
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from baseline to 12 weeks after intervention
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Blood pressure
大体时间:from baseline to 12 weeks after intervention
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alterations of blood pressure
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from baseline to 12 weeks after intervention
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Insulin sensitivity
大体时间:from baseline to 12 weeks after intervention
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alterations of HOMA-IR index
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from baseline to 12 weeks after intervention
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Pro-2021
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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