Effect of Intermittent Calorie Restriction on MASLD Patients With Abnormal Glucose Metabolism

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Fatty Liver Disease; Impaired Glucose Regulation
• Interventions: Behavioral: Intermittent calorie restriction (ICR); Behavioral: Continuous calorie restriction (CCR)

• Registration Number: NCT04283942
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-25
• Study Start: 2020-07-30
• Primary Completion: 2021-07-25
• Study Completion: 2021-07-25
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-24
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Calorie Restriction (ICR)	Intermittent calorie restriction (ICR)	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 (ZhenBaiNian nutrition bar, Beijing Wanlaikang Nutrition and Health Food Science and Technology Research Institute Co., Ltd, China) 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.
Control (Continuous calorie restriction, CCR)	Continuous calorie restriction (CCR)	Participants in control group were instructed to consume the prescribed calories (25 kcal / kg × \[height (cm) - 100\] kg) every day by eating conventional food without time restriction.

Primary Outcome Measures

Name	Time	Method
Change of Liver Fat Content in %	From baseline to week 12	Change of liver fat content in %.

Secondary Outcome Measures

Name	Time	Method
Change of Weight	From baseline to week 12	Change of weight in kilograms.
Change of Blood Glucose: Fasting Blood Glucose	From baseline to week 12	Change of fasting blood glucose in mg/dL.
Change of Blood Glucose: 2h Postload Blood Glucose	From baseline to week 12	Change of 2h postload blood glucose in mg/dL.
Change of HbA1c	From baseline to week 12	Change of HbA1c in %.
Change of Liver Enzymes: Alanine Aminotransferase	From baseline to week 12	Change of alanine aminotransferase in U/L.
Change of Liver Enzymes: Aspartate Aminotransferase	From baseline to week 12	Change of aspartate aminotransferase in U/L.
Change of Liver Enzymes: γ-glutamyl Transpeptidase	From baseline to week 12	Change of γ-glutamyl transpeptidase in U/L.
Change of Lipid Profile: Total Cholesterol	From baseline to week 12	Change of total cholesterol in mg/dL.
Change of Lipid Profile: Triglyceride	From baseline to week 12	Change of triglyceride in mg/dL.
Change of Lipid Profile: High-density Lipoprotein-cholesterol	From baseline to week 12	Change of high-density lipoprotein-cholesterol in mg/dL.
Change of Lipid Profile: Low-density Lipoprotein-cholesterol	From baseline to week 12	Change of low-density lipoprotein-cholesterol in mg/dL.
Change of Lipid Profile: Free Fatty Acid	From baseline to week 12	Change of free fatty acid in mg/dL.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China