Back to resultsPotential Effects of Intermittent Fasting to Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intermittent fasting
Sponsored by
About this trial
This is an interventional prevention trial for 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:
- 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
Sites / Locations
- Department of Nutrition and Food Hygiene
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intermittent fasting
Control diet
Arm Description
two nonconsecutive days of 75% diet energy restriction per week for 8 weeks
maintain the energy intake as usual
Outcomes
Primary Outcome Measures
BMI
BMI(weight in kilograms, height in meters and BMI in kg/m^2)
Body fat mass
Body fat mass (kg)
Secondary Outcome Measures
systolic pressure
systolic pressure(mmHg)
diastolic pressure
diastolic pressure(mmHg)
gut microbiota composition
gut microbiota composition at different levels of classification determined by 16s rRNA pcr
plasma IL-6
plasma interleukin 6 (pg/mL)
plasma TNF-α
plasma TNF-α (pg/mL)
plasma sCD40L
plasma soluble CD40 ligand (ng/mL)
plasma leptin
plasma leptin (ng/mL)
plasma adiponectin
plasma adiponectin (μg/mL)
plasma MDA
plasma malondialdehyde (nmol/mL)
plasma oxLDL
plasma oxidative LDL (mU/L)
plasma total nitrate
plasma total nitrate (mmol/L)
plasma AMDA
plasma asymmetric dimethylarginine (ng/mL)
plasma VCAM-1
plasma vascular cell adhesion protein 1 (ng/mL)
plasma vWF
plasma Von Willebrand factor (U/mL)
metabolic pathway of gut microbiota
metabolic pathway of gut microbiota determined by 16s rRNA pcr
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03608800
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Min Xia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent fasting
Arm Type
Experimental
Arm Description
two nonconsecutive days of 75% diet energy restriction per week for 8 weeks
Arm Title
Control diet
Arm Type
No Intervention
Arm Description
maintain the energy intake as usual
Intervention Type
Behavioral
Intervention Name(s)
Intermittent fasting
Intervention Description
The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks
Primary Outcome Measure Information:
Title
BMI
Description
BMI(weight in kilograms, height in meters and BMI in kg/m^2)
Time Frame
8 weeks
Title
Body fat mass
Description
Body fat mass (kg)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
systolic pressure
Description
systolic pressure(mmHg)
Time Frame
8 weeks
Title
diastolic pressure
Description
diastolic pressure(mmHg)
Time Frame
8 weeks
Title
gut microbiota composition
Description
gut microbiota composition at different levels of classification determined by 16s rRNA pcr
Time Frame
8 weeks
Title
plasma IL-6
Description
plasma interleukin 6 (pg/mL)
Time Frame
8 weeks
Title
plasma TNF-α
Description
plasma TNF-α (pg/mL)
Time Frame
8 weeks
Title
plasma sCD40L
Description
plasma soluble CD40 ligand (ng/mL)
Time Frame
8 weeks
Title
plasma leptin
Description
plasma leptin (ng/mL)
Time Frame
8 weeks
Title
plasma adiponectin
Description
plasma adiponectin (μg/mL)
Time Frame
8 weeks
Title
plasma MDA
Description
plasma malondialdehyde (nmol/mL)
Time Frame
8 weeks
Title
plasma oxLDL
Description
plasma oxidative LDL (mU/L)
Time Frame
8 weeks
Title
plasma total nitrate
Description
plasma total nitrate (mmol/L)
Time Frame
8 weeks
Title
plasma AMDA
Description
plasma asymmetric dimethylarginine (ng/mL)
Time Frame
8 weeks
Title
plasma VCAM-1
Description
plasma vascular cell adhesion protein 1 (ng/mL)
Time Frame
8 weeks
Title
plasma vWF
Description
plasma Von Willebrand factor (U/mL)
Time Frame
8 weeks
Title
metabolic pathway of gut microbiota
Description
metabolic pathway of gut microbiota determined by 16s rRNA pcr
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
serum LDL-cholesterol
Description
serum LDL-cholesterol(mmol/L);
Time Frame
8 weeks
Title
serum HDL-cholesterol
Description
serum HDL-cholesterol (mmol/L);
Time Frame
8 weeks
Title
serum triglyceride
Description
serum triglyceride (mmol/L)
Time Frame
8 weeks
Title
serum Apo B/apo A1
Description
serum Apo B/apo A1
Time Frame
8 weeks
Title
serum glucose
Description
serum glucose (mmol/L)
Time Frame
8 weeks
Title
serum insulin
Description
serum insulin (mU/L)
Time Frame
8 weeks
Title
serum total cholesterol
Description
serum total cholesterol (mmol/L)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Xia, Doctor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition and Food Hygiene
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33017844
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.
Results Reference
derived
Learn more about this trial
Potential Effects of Intermittent Fasting to Metabolic Syndrome
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