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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475822
• Other study ID #: XJTU1AF2020LSK-003
• Status: Completed
• Phase: N/A
• Start date: July 12, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• Intermittent fasting
Intermittent fasting group: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: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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi an Jiaotong University	Xi'an	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Leiden University, The Hospital for Sick Children

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	kg	Three months after the intervention
Primary	body fat		Three months after the intervention
Secondary	blood pressure	mmHg	Three months after the intervention
Secondary	blood glucose	mmol/L	Three months after the intervention
Secondary	blood lipid	mmol/L	Three months after the intervention
Secondary	uric acid	µmol/L	Three months after the intervention