Effect of Intermittent Calorie Restriction on MASLD Patients With Abnormal Glucose Metabolism
Condition: Fatty Liver Disease; Type 2 Diabetes; Impaired Glucose Regulation
MeSH terms: Liver Diseases; Fatty Liver; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study is designed to observe the effect of 5:2 intermittent calorie restriction (fasting
      2 days each week) on liver fat content in MASLD patients with abnormal blood glucose.
    

Detailed description: 
      Intermittent caloric restriction (ICR) can effectively reduce weight and facilitate blood
      glucose control, but whether it can be applied for clinical treatment to metabolic
      dysfunction-associated steatotic liver disease (MASLD) patients remains unclear. We intend to
      carry out this study in MASLD 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 MASLD patients with abnormal
      blood glucose. 60 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 (continuous
      calorie restriction, CCR): 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 × [height (cm) - 100] kg. 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) and
      Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF). The effects of ICR on body
      weight, blood glucose and body fat will also be evaluated. Both groups will be followed up on
      their changes of weight 4 weeks after intervention.
    

Intervention name(s): Intermittent calorie restriction (ICR); Continuous calorie restriction (CCR)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in ICR group were instructed to ensure 2 successive days of fasting-mimicking and 5 days of recovery per week. On fasting-mimicking days, the participants were instructed to consume approximately 500 kcal/day and they were provided with plant-based meal replacement to improve adherence and ensured adequate intake of micronutrients. In the rest 5 days of recovery per week, participants were allowed to consume their usual diet.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat).They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.; Participants in CCR group were instructed to consume the prescribed calories (25 kcal / kg × [height (cm) - 100] kg) every day by eating conventional food without time restriction.
Participants will receive dietary counseling from experienced nutritionists and eat a balanced diet (macronutrient distribution of approximately 10-15% protein, 55-65% carbohydrate and 20-30% fat).They are required to write daily dietary log. Besides, they are required to maintain their exercise routines and record their daily steps using a unified pedometer (Redmi Smart Band, Xiaomi Corporation, China). The use of drugs affecting blood glucose and LFC will be avoided.
Other intervention name(s): Intermittent fasting; Daily calorie restriction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: continuous calorie restriction (CCR). Under the guidance of nutritionist, subjects have to learn the method of food calories calculation. For each day, the daily calories intake is limited to 25 kcal / kg × standard weight [kg, estimated by height (cm) - 100].
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic dysfunction-associated steatotic liver disease; Type 2 Diabetes