Potential Effects of Intermittent Fasting to Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608800
• Other study ID #: 2018IF01-1
• Status: Completed
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: May 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• Intermittent fasting
The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks

Locations

Country	Name	City	State
China	Department of Nutrition and Food Hygiene	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Min Xia

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum LDL-cholesterol	serum LDL-cholesterol(mmol/L);	8 weeks
Other	serum HDL-cholesterol	serum HDL-cholesterol (mmol/L);	8 weeks
Other	serum triglyceride	serum triglyceride (mmol/L)	8 weeks
Other	serum Apo B/apo A1	serum Apo B/apo A1	8 weeks
Other	serum glucose	serum glucose (mmol/L)	8 weeks
Other	serum insulin	serum insulin (mU/L)	8 weeks
Other	serum total cholesterol	serum total cholesterol (mmol/L)	8 weeks
Primary	BMI	BMI(weight in kilograms, height in meters and BMI in kg/m^2)	8 weeks
Primary	Body fat mass	Body fat mass (kg)	8 weeks
Secondary	systolic pressure	systolic pressure(mmHg)	8 weeks
Secondary	diastolic pressure	diastolic pressure(mmHg)	8 weeks
Secondary	gut microbiota composition	gut microbiota composition at different levels of classification determined by 16s rRNA pcr	8 weeks
Secondary	plasma IL-6	plasma interleukin 6 (pg/mL)	8 weeks
Secondary	plasma TNF-a	plasma TNF-a (pg/mL)	8 weeks
Secondary	plasma sCD40L	plasma soluble CD40 ligand (ng/mL)	8 weeks
Secondary	plasma leptin	plasma leptin (ng/mL)	8 weeks
Secondary	plasma adiponectin	plasma adiponectin (µg/mL)	8 weeks
Secondary	plasma MDA	plasma malondialdehyde (nmol/mL)	8 weeks
Secondary	plasma oxLDL	plasma oxidative LDL (mU/L)	8 weeks
Secondary	plasma total nitrate	plasma total nitrate (mmol/L)	8 weeks
Secondary	plasma AMDA	plasma asymmetric dimethylarginine (ng/mL)	8 weeks
Secondary	plasma VCAM-1	plasma vascular cell adhesion protein 1 (ng/mL)	8 weeks
Secondary	plasma vWF	plasma Von Willebrand factor (U/mL)	8 weeks
Secondary	metabolic pathway of gut microbiota	metabolic pathway of gut microbiota determined by 16s rRNA pcr	8 weeks