Effectiveness and Adherence of Modified Alternate-day Calorie Restriction (MACR) in Non-Alcoholic Fatty Liver Disease

NCT03791203 | Completed

• 1 other identifier: 304/PPSP/61313173
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is no effective therapy for non-alcoholic fatty liver disease (NAFLD), although intensive calorie restriction is typically recommended but dietary adherence is an issue. Currently, there are no studies had been focusing the effect of Modified Alternate Day Calorie Restriction in NAFLD patient focusing on changes in liver steatosis and fibrosis.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (9)

• Change from baseline shear wave elastography (SWE) 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 at 8-week

• Change from baseline liver steatosis 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%.

  Change from baseline at 8-week

• Concentration of high-density lipoprotein (HDL)

  Blood samples (8-10 hours of fasting blood samples) were collected from participants at 8-10 am at baseline and 8-week post intervention for biochemical analysis. It was measured in mmol/L.

  Change from baseline at 8-week

• Concentration of low-density lipoprotein (LDL)

  Blood samples (8-10 hours of fasting blood samples) were collected at 8-10 am at baseline and 8-week post intervention for biochemical analysis. It was measured in mmol/L.

  Change from baseline at 8-week

• Concentration of triglycerides (TG)

  Blood samples (8-10 hours of fasting blood samples) were collected at 8-10 am at baseline and 8-week post intervention for biochemical analysis. It was measured in mmol/L.

  Change from baseline at 8-week

• Concentration of total cholesterol (TC)

  Blood samples (8-10 hours of fasting blood samples) were collected at 8-10 am at baseline and 8-week post intervention for biochemical analysis. It was measured in mmol/L.

  Change from baseline at 8-week

• Concentration of fasting blood sugar (FBS)

  Blood samples (8-10 hours of fasting blood samples) were collected at 8-10 am at baseline and 8-week post intervention for biochemical analysis. It was measured in mmol/L.

  Change from baseline at 8-week

• Concentration of alanine aminotransferase (ALT)

  Blood samples (8-10 hours of fasting blood samples) were collected at 8-10 am at baseline and 8-week post intervention for biochemical analysis. It was measured in U/L.

  Change from baseline at 8-week

• Concentration of aspartate aminotransferase (AST)

  Blood samples (8-10 hours of fasting blood samples) were collected at 8-10 am at baseline and 8-week post intervention for biochemical analysis. It was measured in U/L.

  Change from baseline at 8-week

Secondary Outcomes (1)

• Dietary plan adherence

  At 8-week

Study Arms (2)

Calorie restriction (MACR)

EXPERIMENTAL

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 individualized 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.

Behavioral: Calorie restriction (MACR)

Control group

NO INTERVENTION

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.

Interventions

Calorie restriction (MACR) BEHAVIORAL

This was a randomized, single-blind controlled trial with modified alternate-day calorie restriction (MACR) as the active intervention and normal habitual diet as control at Hospital University of Sains Malaysia.

Also known as: Modified Alternate-day Calorie Restriction (MACR)

Calorie restriction (MACR)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant alcohol consumption (\> 1 standard drink per day)
• Pregnancy
• Involvement in an active weight loss program or taking weight loss medications
• Substance abuse and significant psychiatric problems.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Yeong Yeh Lee, MD, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded after assignment to interventions or control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants who fulfilled the selection criteria were randomly assigned to the modified alternate-day calorie restriction (MACR) group or the control group after a 2 week run-in period. During the 2 weeks, participants were required to keep their body weight stable by maintaining their usual eating habits and their daily activities. Randomization was performed using a random number generator with recruitment aimed for three MACR participants for every control participant by principal investigator.

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: January 2, 2019
• Study Start: August 1, 2015
• Primary Completion: July 31, 2017
• Study Completion: October 1, 2017
• Last Updated: January 2, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share