NCT03791203.

Study name	Effectiveness and adherence of Modified Alternate‐day Calorie Restriction (MACR) in non‐alcoholic fatty liver disease
Methods	Randomised controlled trial
Participants	Ages Eligible for Study: 18 years to 70 years (adult, older adult) Sexes Eligible for Study: all Accepts Healthy volunteers: Yes Criteria Inclusion Criteria: Have elevated ALT or AST level (ALT >41 or AST>34 IU/L) No evidence of other forms of liver diseases For those with diabetes mellitus and dyslipidaemia, they must be on a stable therapy for at least 6 months prior to study enrolment
Interventions	Experimental: Calorie restriction (MACR) Participants restricted 70% of their energy needs over 24 hours on a calorie restriction day alternate with a feeding day for the next 24 hours, where they were allowed eating (ad libitum). The calorie restriction and feeding days begun at 9 am each day, and on the calorie restriction day, meals were consumed between 2 pm and 8 pm to ensure that they underwent the same duration of calorie restriction. On each calorie restriction day, they were allowed energy‐free beverages and sugar‐free gum and encouraged to drink plenty of water. Diet plans were self‐selected using detailed individualised food portion lists, meal plans, and recipes. Participants received phone calls from the investigator and four 2‐weekly appointments with a dietitian. Adverse experiences were assessed every 2 weeks. No Intervention: control group Participants in the control group continued their usual habitual diet for 8 weeks. No specific dietary advice or educations were provided throughout the entire trial.
Outcomes	Primary Outcome Measures Change from baseline shear wave elastography (SWE) at 8 weeks [ Time Frame: Change from baseline at 8 weeks ] Through the intercostal approach, SWE measurements were performed in the right liver lobe, at the supine position with the right arm in maximal abduction. The sonographer, assisted by an ultrasonic time‐motion image, located a liver portion of at least 6 cm thick, free of large vascular structures. Once the measurement area had been located, the sonographer pressed the probe button to start an acquisition. Patients were asked to hold their breath for about five seconds, while the stiffness of the region of interest was measured and 10 measurements were made for each patient and the median average value of those measurements was recorded in kilopascals (kPa: metric). Change from baseline liver steatosis at 8 weeks [ Time Frame: Change from baseline at 8 weeks ] Ultra‐sonographic measurements including liver steatosis and shear wave elastography (SWE) were performed with the SuperSonic Imagine's Aixplorer® Ultrasound machine (Super Sonic Image, Aix‐en Provence, France). All measurements were performed by a single sonographer where the inter‐observer agreement level with another experienced sonographer was 85%. Concentration of high‐density lipoprotein (HDL) [ Time Frame: Change from baseline at 8‐weeks ] Blood samples (8‐10 hours of fasting blood samples) were collected from participants at 8 am to 10 am at baseline and 8 weeks post intervention for biochemical analysis. It was measured in mmol/L. Concentration of low‐density lipoprotein (LDL) [ Time Frame: Change from baseline at 8 week ] Blood samples (8‐10 hours of fasting blood samples) were collected at 8 am to 10 am at baseline and 8 weeks post intervention for biochemical analysis. It was measured in mmol/L. Concentration of triglycerides (TG) [ Time Frame: Change from baseline at 8weeks ] Blood samples (8‐10 hours of fasting blood samples) were collected at 8 am to10 am at baseline and 8 weeks post intervention for biochemical analysis. It was measured in mmol/L. Concentration of total cholesterol (TC) [ Time Frame: Change from baseline at 8 weeks ] Blood samples (8‐10 hours of fasting blood samples) were collected at 8 am to 10 am at baseline and 8 weeks post intervention for biochemical analysis. It was measured in mmol/L. Concentration of fasting blood sugar (FBS) [ Time Frame: Change from baseline at 8 weeks ] Blood samples (8‐10 hours of fasting blood samples) were collected at 8 am to10 am at baseline and 8 weeks post intervention for biochemical analysis. It was measured in mmol/L. Concentration of alanine aminotransferase (ALT) [ Time Frame: Change from baseline at 8 weeks ] Blood samples (8‐10 hours of fasting blood samples) were collected at 8 am to 10 am at baseline and 8 weeks post intervention for biochemical analysis. It was measured in U/L. Concentration of aspartate aminotransferase (AST) [ Time Frame: Change from baseline at 8 weeks ] Blood samples (8‐10 hours of fasting blood samples) were collected at 8 am to 10 am at baseline and 8 weeks post intervention for biochemical analysis. It was measured in U/L. Secondary Outcome Measures: Dietary plan adherence [ Time Frame: At 8 weeks ] Adherence data were assessed each week as percentage of adherence
Starting date	August 1, 2015
Contact information	Muhammad Izzad Bin Johari, Principal Investigator, University of Science Malaysia
Notes	NCT03791203