Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Prevalence of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) Among Nurses in a Single Tertiary Care Centre and the Role of Intermittent Fasting in Improving Hepatic Steatosis

Conditions
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Fatty Liver Disease

Intervention / Treatment
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* Behavioral: Intermittent Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nurses at HCTM, 18 years and above Exclusion Criteria: pregnancy previous bariatric surgery liver cirrhosis liver cancer steatogenic drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent Fasting Group<br>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<br>* 3:4 regime<br>|
| No Intervention: Non-Fasting Group<br>Usual care. Not allowed to fast | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fatty liver, MAFLD, intermittent fasting, transient elastography, fibroscan