Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
A Randomized Controlled Trial on the Effectiveness and Adherence of Modified Alternate-day Calorie Restriction (MACR) in Improving Activity of Non-Alcoholic Fatty Liver Disease
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.
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.
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