Potential Effects of Intermittent Fasting to Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2019-05-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intermittent fasting

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

Group Type EXPERIMENTAL

Intermittent fasting

Intervention Type BEHAVIORAL

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

Control diet

maintain the energy intake as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intermittent fasting

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No