Effect of Intermittent Calorie Restriction on NAFLD Patients With Disorders of Glucose Metabolism
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Disorders of Glucose Metabolism
- Impaired Glucose Regulation
- Non Alcoholic Fatty Liver Disease (NAFLD)
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients were randomly divided into intermittent calorie restriction group and control group for 12 weeks of intervention. Both groups will be followed up 4 weeks after intervention. ICR group: during the 2-day fasting-mimicking period each week, the food based on plant ingredients will be served (4 pieces of nutrition bars / day, 1:2:1 for breakfast, lunch and dinner, 124.4kcal/piece, 497.2kcal / day in total). In the rest 5 days each week, subjects are allowed ad libitum to their usual food. Control group: under the guidance of nutritionist, subjects have to learn the method of food calories calculation. For each day, the daily calories intake = 25 kcal / kg × standard weight [kg, male: height (cm) - 105, female: height (cm) - 100].Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Intermittent caloric restriction (ICR) can effectively reduce weight and facilitate blood glucose control, but whether it can be applied for clinical treatment to non-alcoholic fatty liver disease (NAFLD) patients remains unclear. What's more, in order to investigate whether the mechanism of glucose...
Intermittent caloric restriction (ICR) can effectively reduce weight and facilitate blood glucose control, but whether it can be applied for clinical treatment to non-alcoholic fatty liver disease (NAFLD) patients remains unclear. What's more, in order to investigate whether the mechanism of glucose-lowering effect of ICR is related to the decrease of liver fat content, we intend to carry out this study in NAFLD patients with abnormal glucose metabolism. It is an open-labeled randomized trial designed to observe the effect of 5:2 intermittent calorie restriction (fasting 2 days each week) on liver fat content in NAFLD patients with abnormal blood glucose. 50 patients will be randomly divided into ICR group and control group for 12 weeks of intervention. ICR group: during the 2-day fasting-mimicking period each week, the food based on plant ingredients will be served (4 pieces of nutrition bars / day, 1:2:1 for breakfast, lunch and dinner, 124.4kcal / piece, 497.2kcal / day in total). In the rest 5 days each week, subjects are allowed ad libitum to their usual food. Control group: under the guidance of nutritionist, subjects have to learn the method of food calories calculation. The daily calories intake for control group should be: 25 kcal / kg × standard weight [kg, male: height (cm) - 105, female: height (cm) - 100]. Daily food diary is required in both groups. During the experiment, all subjects should maintain their exercise routine. The use of drugs affecting blood glucose and fatty liver should be avoided. After 12 weeks of intervention, the changes of liver fat content were evaluated by magnetic resonance spectroscopy (MRS), magnetic resonance imaging-proton density fat fraction (MRI-PDFF) and quantitative ultrasound method. The effects of ICR on body weight, blood glucose, body fat distribution and appetite will also be evaluated. Both groups will be followed up on their changes of weight 4 weeks after intervention.
Tracking Information
- NCT #
- NCT04283942
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Hua Bian Shanghai Zhongshan Hospital Study Director: Xin Gao Shanghai Zhongshan Hospital
Get Well Soon