Skip to main content
OpenTrials
Completed

NCT Number: NCT03608800

Potential Effects of Intermittent Fasting to Metabolic Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition and Food Hygiene

Guangzhou, Guangdong, 510080, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent fasting

Behavioral

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

Primary outcomes

  1. BMI

    Time frame: 8 weeks

    BMI(weight in kilograms, height in meters and BMI in kg/m^2)

  2. Body fat mass

    Time frame: 8 weeks

    Body fat mass (kg)

Secondary outcomes

  1. systolic pressure

    Time frame: 8 weeks

    systolic pressure(mmHg)

  2. diastolic pressure

    Time frame: 8 weeks

    diastolic pressure(mmHg)

  3. gut microbiota composition

    Time frame: 8 weeks

    gut microbiota composition at different levels of classification determined by 16s rRNA pcr

  4. plasma IL-6

    Time frame: 8 weeks

    plasma interleukin 6 (pg/mL)

  5. plasma TNF-α

    Time frame: 8 weeks

    plasma TNF-α (pg/mL)

  6. plasma sCD40L

    Time frame: 8 weeks

    plasma soluble CD40 ligand (ng/mL)

  7. plasma leptin

    Time frame: 8 weeks

    plasma leptin (ng/mL)

  8. plasma adiponectin

    Time frame: 8 weeks

    plasma adiponectin (μg/mL)

  9. plasma MDA

    Time frame: 8 weeks

    plasma malondialdehyde (nmol/mL)

  10. plasma oxLDL

    Time frame: 8 weeks

    plasma oxidative LDL (mU/L)

  11. plasma total nitrate

    Time frame: 8 weeks

    plasma total nitrate (mmol/L)

  12. plasma AMDA

    Time frame: 8 weeks

    plasma asymmetric dimethylarginine (ng/mL)

  13. plasma VCAM-1

    Time frame: 8 weeks

    plasma vascular cell adhesion protein 1 (ng/mL)

  14. plasma vWF

    Time frame: 8 weeks

    plasma Von Willebrand factor (U/mL)

  15. metabolic pathway of gut microbiota

    Time frame: 8 weeks

    metabolic pathway of gut microbiota determined by 16s rRNA pcr

Other outcomes

  1. serum LDL-cholesterol

    Time frame: 8 weeks

    serum LDL-cholesterol(mmol/L);

  2. serum HDL-cholesterol

    Time frame: 8 weeks

    serum HDL-cholesterol (mmol/L);

  3. serum triglyceride

    Time frame: 8 weeks

    serum triglyceride (mmol/L)

  4. serum Apo B/apo A1

    Time frame: 8 weeks

    serum Apo B/apo A1

  5. serum glucose

    Time frame: 8 weeks

    serum glucose (mmol/L)

  6. serum insulin

    Time frame: 8 weeks

    serum insulin (mU/L)

  7. serum total cholesterol

    Time frame: 8 weeks

    serum total cholesterol (mmol/L)

Sponsors and collaborators

Lead sponsor

Min Xia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.