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

September 24, 2023 updated by: Hua Bian, Shanghai Zhongshan Hospital

Effect of Intermittent Calorie Restriction on Metabolic Dysfunction-Associated Steatotic Liver Disease Patients With Abnormal Glucose Metabolism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Zhongshan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age 18-70
  • Diagnosed as fatty liver by ultrasound or magnetic resonance imaging
  • BMI ≥ 24 kg/m2

  • abnormal glucose metabolism: (meeting at least one):

    1. Impaired glucose regulation: fasting blood glucose ≥ 100 mg/dL, postprandial blood glucose ≥ 140 mg/dL or HbA1c ≥ 5.7%
    2. Diabetes mellitus: diabetic symptoms + plasma glucose concentration ≥ 200 mg/dL at any time or fasting plasma glucose concentration ≥ 100 mg/dL or OGTT 2 h plasma glucose concentration ≥ 200 mg/dL

Exclusion Criteria

  • Type 1 diabetes, gestational diabetes and other special types of diabetes
  • Poor blood glucose control, HbA1c > 8.5% within 3 months
  • Taking antidiabetic drugs in the past month
  • Serum ALT > 6 times of normal upper limit
  • Excessive alcohol consumption (alcohol intake: men > 140 g, women > 70 g in the past 6 months)
  • Other liver diseases: such as acute and chronic viral hepatitis, drug-induced hepatitis, immune hepatitis, liver cirrhosis, liver cancer, etc
  • Taking drugs that may affect MASLD in the past three months, such as vitamin E
  • Biliary obstructive diseases
  • Other diseases affecting glucose and lipid metabolism: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc
  • Chronic kidney disease (serum creatinine ≥ 2.0 mg/dL)
  • Life expectancy of no more than 5 years
  • Already pregnant or plan to be pregnant in the near future
  • Mental illness
  • Other conditions affecting follow-up
  • Have participated in other clinical trials in the past 4 weeks
  • Absent of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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 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.

Other Names:
  • Intermittent fasting
Other: Control (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.
Behavioral: Continuous calorie restriction (CCR)

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 Names:
  • Daily calorie restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of liver fat content in %
Time Frame: 12 weeks
Change of liver fat content in %.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of weight
Time Frame: 12 weeks
Change of weight in kilograms.
12 weeks
Change of blood glucose: fasting blood glucose
Time Frame: 12 weeks
Change of fasting blood glucose in mmol/L.
12 weeks
Change of blood glucose: 2h postload blood glucose
Time Frame: 12 weeks
Change of 2h postload blood glucose in mmol/L.
12 weeks
Change of HbA1c
Time Frame: 12 weeks
Change of HbA1c in %.
12 weeks
Change of liver enzymes: alanine aminotransferase
Time Frame: 12 weeks
Change of alanine aminotransferase in U/L.
12 weeks
Change of liver enzymes: aspartate aminotransferase
Time Frame: 12 weeks
Change of aspartate aminotransferase in U/L.
12 weeks
Change of liver enzymes: γ-glutamyl transpeptidase
Time Frame: 12 weeks
Change of γ-glutamyl transpeptidase in U/L.
12 weeks
Change of lipid profile: total cholesterol
Time Frame: 12 weeks
Change of total cholesterol in mmol/L.
12 weeks
Change of lipid profile: triglyceride
Time Frame: 12 weeks
Change of triglyceride in mmol/L.
12 weeks
Change of lipid profile: high-density lipoprotein-cholesterol
Time Frame: 12 weeks
Change of high-density lipoprotein-cholesterol in mmol/L.
12 weeks
Change of lipid profile: low-density lipoprotein-cholesterol
Time Frame: 12 weeks
Change of low-density lipoprotein-cholesterol in mmol/L.
12 weeks
Change of lipid profile: free fatty acid
Time Frame: 12 weeks
Change of free fatty acid in mmol/L.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of fat mass
Time Frame: 12 weeks
measured by bioimpedance analyzer, fat mass in kilograms.
12 weeks
Change of lean mass
Time Frame: 12 weeks
measured by bioimpedance analyzer, skeletal muscle mass in kilograms.
12 weeks
Change of abdominal adiposity
Time Frame: 12 weeks
measured by MRI, including visceral adipose tissue and subcutaneous adipose tissue, all in square centimetres.
12 weeks
Change of liver stiffness measure of liver transient elastography
Time Frame: 12 weeks
Change of liver stiffness measure of liver transient elastography, in kPa.
12 weeks
Change of insulin sensitivity
Time Frame: 12 weeks
Change of HOMA-IR (fasting glucose in mmol/L x fasting insulin in μU/mL)/22.5).
12 weeks
Change of fasting insulin
Time Frame: 12 weeks
Change of fasting insulin in μU/mL.
12 weeks
Change of brain functional MRI
Time Frame: 12 weeks
Brain functional MRI will be used to evaluate the neural activity of the brain.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Hua Bian, Shanghai Zhongshan Hospital
  • Study Director: Xin Gao, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2020

Primary Completion (Actual)

July 25, 2021

Study Completion (Actual)

July 25, 2021

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2019-256R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Intermittent calorie restriction (ICR)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe