Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Behavioral: Intermittent fasting; Behavioral: Low carb diet; Behavioral: Low carbon diet and intermittent fasting group

• Registration Number: NCT04475822
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-12
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-17
• Primary Completion: 2021-01-31
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent fasting	Intermittent fasting	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.
Low carb diet	Low carb diet	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.
Low carbon diet and intermittent fasting group	Low carbon diet and intermittent fasting group	Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.

Primary Outcome Measures

Name	Time	Method
weight	Three months after the intervention	kg
body fat	Three months after the intervention

Secondary Outcome Measures

Name	Time	Method
blood pressure	Three months after the intervention	mmHg
blood glucose	Three months after the intervention	mmol/L
uric acid	Three months after the intervention	µmol/L
blood lipid	Three months after the intervention	mmol/L

Trial Locations

Locations (1)

First Affiliated Hospital of Xi an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China