Metabolic Syndrome
Conditions
Brief summary
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
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
Interventions
BEHAVIORALIntermittent fasting
The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks
Sponsors
Min Xia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No
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: 1. Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L) 2. 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 3. Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg or receiving medication of hypertension 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI | 8 weeks | BMI(weight in kilograms, height in meters and BMI in kg/m\^2) |
| Body fat mass | 8 weeks | Body fat mass (kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma sCD40L | 8 weeks | plasma soluble CD40 ligand (ng/mL) |
| plasma MDA | 8 weeks | plasma malondialdehyde (nmol/mL) |
| plasma oxLDL | 8 weeks | plasma oxidative LDL (mU/L) |
| plasma total nitrate | 8 weeks | plasma total nitrate (mmol/L) |
| plasma AMDA | 8 weeks | plasma asymmetric dimethylarginine (ng/mL) |
| plasma VCAM-1 | 8 weeks | plasma vascular cell adhesion protein 1 (ng/mL) |
| plasma vWF | 8 weeks | plasma Von Willebrand factor (U/mL) |
| metabolic pathway of gut microbiota | 8 weeks | metabolic pathway of gut microbiota determined by 16s rRNA pcr |
| systolic pressure | 8 weeks | systolic pressure(mmHg) |
| diastolic pressure | 8 weeks | diastolic pressure(mmHg) |
| gut microbiota composition | 8 weeks | gut microbiota composition at different levels of classification determined by 16s rRNA pcr |
| plasma IL-6 | 8 weeks | plasma interleukin 6 (pg/mL) |
| plasma TNF-α | 8 weeks | plasma TNF-α (pg/mL) |
| plasma leptin | 8 weeks | plasma leptin (ng/mL) |
| plasma adiponectin | 8 weeks | plasma adiponectin (μg/mL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| serum Apo B/apo A1 | 8 weeks | serum Apo B/apo A1 |
| serum glucose | 8 weeks | serum glucose (mmol/L) |
| serum insulin | 8 weeks | serum insulin (mU/L) |
| serum total cholesterol | 8 weeks | serum total cholesterol (mmol/L) |
| serum HDL-cholesterol | 8 weeks | serum HDL-cholesterol (mmol/L); |
| serum triglyceride | 8 weeks | serum triglyceride (mmol/L) |
| serum LDL-cholesterol | 8 weeks | serum LDL-cholesterol(mmol/L); |
Countries
China
Outcome results
None listed