Fatty Liver Disease
Conditions
Keywords
fatty liver, MAFLD, intermittent fasting, transient elastography, fibroscan
Brief summary
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
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).
Interventions
BEHAVIORALIntermittent Fasting
3:4 regime
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* nurses at HCTM, 18 years and above
Exclusion criteria
* pregnancy * previous bariatric surgery * liver cirrhosis * liver cancer * steatogenic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of controlled attenuated parameter (CAP) (dB/m) | 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of hepatic fibrosis score (kPa) | 8 weeks | measured by transient elastography (Fibroscan). The higher the value, the more severe the degree of fibrosis. Range of score: 1-25 kPa |
| Mean change of steatotest, actitest, and fibrotest scores | 8 weeks | measured by blood test LiverFASt. The higher the value, more severe the degree of steatosis, inflammation, and fibrosis. Range of score: 0 - 1 |
| mean change of Body Mass Index | 8 weeks | 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 |
Countries
Malaysia
Contacts
Primary ContactKhairul Najmi M Nawawi
Outcome results
None listed