Effectiveness and Adherence of Modified Alternate-day Calorie Restriction (MACR) in Non-Alcoholic Fatty Liver Disease
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

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.
    

Detailed description: 
      Disease activity and progression of non-alcoholic fatty liver disease (NAFLD) to
      non-alcoholic steatohepatitis (NASH) and cirrhosis can be highly variable, where 2-3% will
      eventually progress to end-stage liver diseases. With the rising prevalence of metabolic
      syndrome and obesity, NAFLD has become the most frequent form of chronic liver disease in the
      West but also in Asia.

      There are good evidence that weight loss is effective in improving liver histology in NAFLD,
      for example, 31 obese patients with NASH was randomised into intensive lifestyle changes over
      48 weeks versus structured basic education only, and the intensive lifestyle group showed
      significant improvements in steatosis, necrosis, and inflammation. Intense calorie
      restriction is the recommended form of dietary strategy for management of NAFLD. Even though
      such intense dietary strategy has proven to be effective, some patients find it difficult to
      adhere and maintain.

      On the other hand, intermittent fasting achieves more consistent weight loss by improving
      adherence, as intermittent fasting only requires calorie restriction every other day compared
      to conventional form of daily calorie restriction. Alternate day calorie restriction can be
      divided into two components, a 'feed day' and a 'fast day' where food is consumed ad libitum
      for 24 hours period alternating with either complete or partial (modified) calorie
      restriction for the next 24 hours. MACR, the dietary strategy employed in the investigator's
      study, restricts 70% of an individual's daily requirement of calorie per day. There are other
      forms of intermittent fasting, for example, 2-4 days of ad libitum feeding alternating with
      2-4 days of calorie restriction.

      Currently, there are no approved pharmacological therapies for NAFLD, and many guidelines
      advocate recommendation with a focus on controlling risk factors and lifestyle interventions
      that include dietary and physical activities. No specific NAFLD trials have evaluated the
      effectiveness of modified form of intermittent fasting in the control of NAFLD activity.
    

Intervention name(s): Calorie restriction (MACR)
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): Modified Alternate-day Calorie Restriction (MACR)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Non-alcoholic fatty liver disease