NCT03608800已完成不适用
Potential Effects of Intermittent Fasting to Gut Microbiota of Metabolic Syndrome Subjects
Min Xia1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2018年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Body fat mass
研究概览
简要总结
The survey is designed to investigate whether 8 weeks of discrete two-day intermittent fasting per week will impact gut microbiota and cardiovascular risks of metabolic syndrome subjects.
详细描述
Intermittent fasting was demonstrated to optimize energy metabolism and promote health. However, the benefits of intermittent fasting to gut microbiota are remain unclear. Further evidence is needed in understanding the effects of intermittent fasting to gut microbiota and cardiovascular risks in subjects with metabolic syndrome
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
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Local residents aged between 30 to 50 years old
- •Stable body weight (change <±10% of body weight) for 3 months before the study
- •Central obesity: waist circumference ≥90 cm in males or ≥80 cm in females; plus any two of the following four conditions:
- •Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L)
- •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
- •Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg or receiving medication of hypertension
- •Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L)
排除标准
- •History of cardiovascular and cerebrovascular diseases
- •Acute or chronic infectious diseases within 4 weeks
- •Known malignant tumor
- •Alcohol abuse (weekly consumption of alcohol is more than 70 g in females or 140 g in males)
- •Regular therapy with antihypertensive drug, hypolipidemic agents, hypoglycemic agents, hormonal agents and antidepressants within 6 months
- •Use of probiotics, prebiotics or antibiotics within 3 months and in progress of study
- •Use of antiinflammatory drug in progress of study
- •Following a vegetarian diet or veganism
- •Women who are pregnant or intend to be pregnant during the research
结局指标
主要结局
Body fat mass
时间窗: 8 weeks
Body fat mass (kg)
BMI
时间窗: 8 weeks
BMI(weight in kilograms, height in meters and BMI in kg/m\^2)
次要结局
- diastolic pressure(8 weeks)
- plasma IL-6(8 weeks)
- plasma adiponectin(8 weeks)
- plasma AMDA(8 weeks)
- plasma VCAM-1(8 weeks)
- gut microbiota composition(8 weeks)
- plasma TNF-α(8 weeks)
- plasma leptin(8 weeks)
- systolic pressure(8 weeks)
- plasma oxLDL(8 weeks)
- plasma total nitrate(8 weeks)
- plasma vWF(8 weeks)
- metabolic pathway of gut microbiota(8 weeks)
- plasma sCD40L(8 weeks)
- plasma MDA(8 weeks)
研究者
Min Xia
professor
Sun Yat-sen University
研究点 (1)
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