Potential Effects of Intermittent Fasting to Metabolic Syndrome

Min Xia

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Behavioral: Intermittent fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT03608800

2018IF01-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 39 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Intermittent fasting

Experimental group

Description:

two nonconsecutive days of 75% diet energy restriction per week for 8 weeks

Treatment:

Behavioral: Intermittent fasting

Control diet

No Intervention group

Description:

maintain the energy intake as usual