Potential Effects of Intermittent Fasting to Metabolic Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Intermittent fasting

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Department of Nutrition and Food Hygiene

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent fasting; two nonconsecutive days of 75% diet energy restriction per week for 8 weeks	Behavioral: Intermittent fasting; The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks
No Intervention: Control diet; maintain the energy intake as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	BMI(weight in kilograms, height in meters and BMI in kg/m^2)	8 weeks
Body fat mass	Body fat mass (kg)	8 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum LDL-cholesterol	serum LDL-cholesterol(mmol/L);	8 weeks
serum HDL-cholesterol	serum HDL-cholesterol (mmol/L);	8 weeks
serum triglyceride	serum triglyceride (mmol/L)	8 weeks
serum Apo B/apo A1	serum Apo B/apo A1	8 weeks
serum glucose	serum glucose (mmol/L)	8 weeks
serum insulin	serum insulin (mU/L)	8 weeks
serum total cholesterol	serum total cholesterol (mmol/L)	8 weeks

Collaborators and Investigators

• Sponsor: Min Xia
• Investigators: Principal Investigator: Min Xia, Doctor, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: July 22, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 24, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 2018IF01-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No