Potential Effects of Intermittent Fasting to Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Potential Effects of Intermittent Fasting to Gut Microbiota of Metabolic Syndrome Subjects

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Intermittent fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent fasting<br>two nonconsecutive days of 75% diet energy restriction per week for 8 weeks | Behavioral: Intermittent fasting<br>* The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks<br>|
| No Intervention: Control diet<br>maintain the energy intake as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | BMI(weight in kilograms, height in meters and BMI in kg/m^2) | 8 weeks | 
| Body fat mass | Body fat mass (kg) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic pressure | systolic pressure(mmHg) | 8 weeks | 
| diastolic pressure | diastolic pressure(mmHg) | 8 weeks | 
| gut microbiota composition | gut microbiota composition at different levels of classification determined by 16s rRNA pcr | 8 weeks | 
| plasma IL-6 | plasma interleukin 6 (pg/mL) | 8 weeks | 
| plasma TNF-α | plasma TNF-α (pg/mL) | 8 weeks | 
| plasma sCD40L | plasma soluble CD40 ligand (ng/mL) | 8 weeks | 
| plasma leptin | plasma leptin (ng/mL) | 8 weeks | 
| plasma adiponectin | plasma adiponectin (μg/mL) | 8 weeks | 
| plasma MDA | plasma malondialdehyde (nmol/mL) | 8 weeks | 
| plasma oxLDL | plasma oxidative LDL (mU/L) | 8 weeks | 
| plasma total nitrate | plasma total nitrate (mmol/L) | 8 weeks | 
| plasma AMDA | plasma asymmetric dimethylarginine (ng/mL) | 8 weeks | 
| plasma VCAM-1 | plasma vascular cell adhesion protein 1 (ng/mL) | 8 weeks | 
| plasma vWF | plasma Von Willebrand factor (U/mL) | 8 weeks | 
| metabolic pathway of gut microbiota | metabolic pathway of gut microbiota determined by 16s rRNA pcr | 8 weeks |