Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880316
• Other study ID #: UKM/PPI/111/8/JEP-2023-276
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2023
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: Khairul Najmi M Nawawi
• Phone: +60391455555
• Email: khairulnajmi84[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• nurses at HCTM, 18 years and above

Exclusion Criteria:

• pregnancy

• previous bariatric surgery

• liver cirrhosis

• liver cancer

• steatogenic drugs

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver Disease
• Liver Diseases

Intervention

Behavioral:
• Intermittent Fasting
3:4 regime

Locations

Country	Name	City	State
Malaysia	Hospital Canselor Tuanku Muhriz	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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