Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

Sponsor

Universiti Kebangsaan Malaysia Medical Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT05880316

Collaborator

(none)

100

Enrollment

Location

Arms

3.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatty Liver Disease	Behavioral: Intermittent Fasting	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled TrialRandomized Controlled Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 28, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intermittent Fasting Group 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 3:4 regime
No Intervention: Non-Fasting Group Usual care. Not allowed to fast

Arm

Intervention/Treatment

Experimental: Intermittent Fasting Group

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

3:4 regime

No Intervention: Non-Fasting Group

Usual care. Not allowed to fast

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

nurses at HCTM, 18 years and above

Exclusion Criteria:

pregnancy
previous bariatric surgery
liver cirrhosis
liver cancer
steatogenic drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Canselor Tuanku Muhriz	Cheras	Kuala Lumpur	Malaysia	56000

Sponsors and Collaborators

Universiti Kebangsaan Malaysia Medical Centre

Investigators

Principal Investigator: Khairul Najmi M Nawawi, Gastroenterology Unit, Department of Medicine, Faculty of Medicine, UKM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khairul Najmi, Dr, Universiti Kebangsaan Malaysia Medical Centre

ClinicalTrials.gov Identifier:

NCT05880316

Other Study ID Numbers:

UKM/PPI/111/8/JEP-2023-276

First Posted:

May 30, 2023

Last Update Posted:

May 30, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Khairul Najmi, Dr, Universiti Kebangsaan Malaysia Medical Centre

fatty liver

MAFLD

intermittent fasting

transient elastography

fibroscan

Additional relevant MeSH terms:

Liver Diseases

Fatty Liver

Study Results

No Results Posted as of May 30, 2023