Clinical trial NCT03608800: Potential Effects of Intermittent Fasting to Metabolic Syndrome
Official title: Potential Effects of Intermittent Fasting to Gut Microbiota of Metabolic Syndrome Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 39
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: BMI
timeFrame: 8 weeks
measure: Body fat mass
timeFrame: 8 weeks
Secondary outcomes:
measure: systolic pressure
timeFrame: 8 weeks
measure: diastolic pressure
timeFrame: 8 weeks
measure: gut microbiota composition
timeFrame: 8 weeks
measure: plasma IL-6
timeFrame: 8 weeks
measure: plasma TNF-α
timeFrame: 8 weeks
measure: plasma sCD40L
timeFrame: 8 weeks
measure: plasma leptin
timeFrame: 8 weeks
measure: plasma adiponectin
timeFrame: 8 weeks
measure: plasma MDA
timeFrame: 8 weeks
measure: plasma oxLDL
timeFrame: 8 weeks
measure: plasma total nitrate
timeFrame: 8 weeks
measure: plasma AMDA
timeFrame: 8 weeks
measure: plasma VCAM-1
timeFrame: 8 weeks
measure: plasma vWF
timeFrame: 8 weeks
measure: metabolic pathway of gut microbiota
timeFrame: 8 weeks
Other outcomes:
measure: serum LDL-cholesterol
timeFrame: 8 weeks
measure: serum HDL-cholesterol
timeFrame: 8 weeks
measure: serum triglyceride
timeFrame: 8 weeks
measure: serum Apo B/apo A1
timeFrame: 8 weeks
measure: serum glucose
timeFrame: 8 weeks
measure: serum insulin
timeFrame: 8 weeks
measure: serum total cholesterol
timeFrame: 8 weeks
Locations:
city: Guangzhou
country: China
facility: Department of Nutrition and Food Hygiene
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Min Xia, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo Y, Luo S, Ye Y, Yin S, Fan J, Xia M. Intermittent Fasting Improves Cardiometabolic Risk Factors and Alters Gut Microbiota in Metabolic Syndrome Patients. J Clin Endocrinol Metab. 2021 Jan 1;106(1):64-79. doi: 10.1210/clinem/dgaa644.