Completed

An Intervention Study of Intermittent Fasting and Low Carbon Diet in Patients With Metabolic Syndrome

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What is being tested

Intermittent fasting

+ Low carb diet

+ Low carbon diet and intermittent fasting group

Behavioral
Who is being recruted

Hyperinsulinism+3

+ Insulin Resistance

+ Metabolic Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2020
See protocol details

Summary

Principal SponsorFirst Affiliated Hospital Xi'an Jiaotong University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 12, 2020

Actual date on which the first participant was enrolled.

The prevalence of metabolic syndrome (MetS) is increasing all over the world, which is largely related to the increasing obesity population and the current inactive lifestyle of human beings. It is a common problem facing public health and clinical practice.Metabolic syndrome is an accumulation of biologically metabolic risk factors related to cardiovascular disease and diabetes, including glucose metabolism disorders, hypertension, dyslipidemia, and obesity (especially central obesity).Researchers believe that the common pathological basis of these manifestations is insulin resistance, which is generally considered to be a reduction in the biological effects of insulin compared with the normal biological effects of expected biological phenomena.Nowadays, there are more and more studies on insulin resistance in the world. We have known that age, poor living and eating habits, high blood fat, high blood sugar and stress all lead to insulin resistance. The researchers hope to reduce weight, reduce body fat rate, improve body fat distribution and insulin resistance, reverse abnormal metabolic indicators, and ultimately reduce the incidence of chronic diseases in patients with metabolic syndrome through the intervention of lifestyle and diet habits in the early stage of the disease.

Official TitleAn Intervention Study of Intermittent Fasting and Low Carbon Diet in Patients With Metabolic Syndrome
NCT04475822
Principal SponsorFirst Affiliated Hospital Xi'an Jiaotong University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

169 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesMetabolic SyndromeGlucose Metabolism Disorders

Criteria

Inclusion criteria 1. Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5): 1. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women). 2. Elevated TG (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L). 3. Reduced HDL-c (use of medications for reduced HDL-c is an alternate indicator) \< 40 mg/dL (1.0 mmol/L) in males \< 50 mg/dL (1.3 mmol/L) in females. 4. Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). SBP ≥ 130 and/or DBP ≥ 85 mmHg. 5. Elevated FBG (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L). 2. Age from 18 to 65 years. 3. Stable weight (change ≤ 10% current body weight) for 3 months prior to the study. 4. If participates were on hypoglycemic medications, hypotensive medications, lipid-lowering medications and cardiovascular medications, dose adjustment was not permitted during the 3-month intervention. Exclusion criteria 1. Pregnant or breast-feeding. 2. Night shift workers. 3. History of major diseases or related diseases, such as inflammatory disease, rheumatologic disease, adrenal disease, malignancy, type 1 diabetes, cirrhosis, chronic kidney disease, acquired immunodeficiency syndrome, eating disorder, uncontrolled psychiatric disorder and major adverse cardiovascular event. 4. Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite. 5. History of weight-loss surgery.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.

Group II

Experimental
According to the definition of low carbon diet given by R. D. Feinman et al. (Nutrition, 2015), the daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.

Group III

Experimental
Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

First Affiliated Hospital of Xi an Jiaotong University

Xi'an, ChinaOpen First Affiliated Hospital of Xi an Jiaotong University in Google Maps
CompletedOne Study Center