Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

Not Applicable

Recruiting

• Conditions: Fatty Liver Disease
• Interventions: Behavioral: Intermittent Fasting

• Registration Number: NCT05880316
• Lead Sponsor: Universiti Kebangsaan Malaysia Medical Centre

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).

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study Start: 2023-05-28
• Study First Posted: 2023-05-30
• Last Update Posted: 2023-05-30
• Primary Completion: 2023-06-30
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• nurses at HCTM, 18 years and above

Exclusion Criteria

• pregnancy
• previous bariatric surgery
• liver cirrhosis
• liver cancer
• steatogenic drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Fasting Group	Intermittent Fasting	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Hospital Canselor Tuanku Muhriz; 🇲🇾 Cheras, Kuala Lumpur, Malaysia