An interventional study of Intermittent Fasting in Fatty Liver Disease, sponsored by Universiti Kebangsaan Malaysia Medical Centre. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-30.
Sponsored by Universiti Kebangsaan Malaysia Medical Centre · Not applicable, Interventional, and Treatment
This study consists of 2 parts:
Part 1: a cross-sectional study, looking at the prevalence of metabolic dysfunction-associated fatty liver disease (MAFLD) among nurses in Hospital Canselor Tuanku Muhriz (HCTM).
Part 2: a randomized controlled trial of intermittent fasting with MAFLD subjects.
The investigators aim to screen at least 350 participants for fibroscan-detected fatty liver. Baseline anthropometric data will be taken. Questionnaires on dietary habits - Foof Frequency Questionnaire (FFQ) and exercise habits - International Physical Activity Questionnaire (IPAQ) will be done.
Approximately 100 participants who have fatty liver from Part 1 study, will be enrolled and randomized into Part 2. The intervention group will undergo intermittent fasting (3 fasting day:4 non-fasting days) while the control group will continue the usual standard care, for 8 weeks.
Measurements pre- and post-intervention include Fibroscan measurement, blood LiverFASt, anthropometric data, and exercise habit (IPAQ).
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Universiti Kebangsaan Malaysia Medical Centre is the lead sponsor of 58 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
IF regime: 3 fasting day: 4 non-fasting day. On fasting day - allows to eat restricted calorie diet (up to 70% total daily calorie intake) for 8 hours.
Behavioral: Intermittent Fasting
Usual care. Not allowed to fast
3:4 regime
Mean change of controlled attenuated parameter (CAP) (dB/m)
hepatic steatosis score - measured by transient elastography (Fibroscan). The higher the value, the more severe the degree of steatosis. Range of score: 100-500dB/m
Time frame: 8 weeks
Mean change of hepatic fibrosis score (kPa)
measured by transient elastography (Fibroscan). The higher the value, the more severe the degree of fibrosis. Range of score: 1-25 kPa
Time frame: 8 weeks
Mean change of steatotest, actitest, and fibrotest scores
measured by blood test LiverFASt. The higher the value, more severe the degree of steatosis, inflammation, and fibrosis. Range of score: 0 - 1
Time frame: 8 weeks
mean change of Body Mass Index
The higher the value, the more overweight/obese patient is. BMI is measured by (weight in kg/height x height in meter). BMI category is based on Asian classification: \<18.5: underweight, 18.5 - 22.9: normal, 23 - 27.5: overweight, \>27.5 obese
Time frame: 8 weeks
Plan to share: No — undecided
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Non-alcoholic Fatty Liver Disease →
Universiti Kebangsaan Malaysia Medical Centre