Potential Effects of Intermittent Fasting to Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Behavioral: Intermittent fasting

• Registration Number: NCT03608800
• Lead Sponsor: Min Xia

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

Study Timeline

• Study Start: 2018-06-30
• Study First Submitted: 2018-07-22
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-24
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent fasting	Intermittent fasting	two nonconsecutive days of 75% diet energy restriction per week for 8 weeks

Primary Outcome Measures

Name	Time	Method
Body fat mass	8 weeks	Body fat mass (kg)
BMI	8 weeks	BMI(weight in kilograms, height in meters and BMI in kg/m\^2)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nutrition and Food Hygiene; 🇨🇳 Guangzhou, Guangdong, China