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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Fasting Group | Experimental | 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. |
|
| Non-Fasting Group | No Intervention | Usual care. Not allowed to fast |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Fasting | Behavioral | 3:4 regime |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khairul Najmi M Nawawi | Contact | +60391455555 | khairulnajmi84@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Khairul Najmi M Nawawi | Gastroenterology Unit, Department of Medicine, Faculty of Medicine, UKM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Canselor Tuanku Muhriz | Recruiting | Cheras | Kuala Lumpur | 56000 | Malaysia |
undecided
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
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Randomized Controlled Trial
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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 |
| D001519 |
| Behavior |