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Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

Primary Purpose

Fatty Liver Disease

Status

Recruiting

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Intermittent Fasting

About this trial

This is an interventional treatment trial for Fatty Liver Disease focused on measuring fatty liver, MAFLD, intermittent fasting, transient elastography, fibroscan

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: nurses at HCTM, 18 years and above Exclusion Criteria: pregnancy previous bariatric surgery liver cirrhosis liver cancer steatogenic drugs

Sites / Locations

Hospital Canselor Tuanku MuhrizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intermittent Fasting Group

Non-Fasting Group

Arm Description

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.

Usual care. Not allowed to fast

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT05880316

First Posted

May 10, 2023

Last Updated

May 19, 2023

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

1. Study Identification

Unique Protocol Identification Number

NCT05880316

Brief Title

Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 28, 2023 (Anticipated)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatty Liver Disease

Keywords

fatty liver, MAFLD, intermittent fasting, transient elastography, fibroscan

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Controlled Trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intermittent Fasting Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Non-Fasting Group

Arm Type

No Intervention

Arm Description

Usual care. Not allowed to fast

Intervention Type

Behavioral

Intervention Name(s)

Intermittent Fasting

Intervention Description

3:4 regime

Primary Outcome Measure Information:

Title

Mean change of controlled attenuated parameter (CAP) (dB/m)

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Mean change of hepatic fibrosis score (kPa)

Description

measured by transient elastography (Fibroscan). The higher the value, the more severe the degree of fibrosis. Range of score: 1-25 kPa

Time Frame

8 weeks

Title

Mean change of steatotest, actitest, and fibrotest scores

Description

measured by blood test LiverFASt. The higher the value, more severe the degree of steatosis, inflammation, and fibrosis. Range of score: 0 - 1

Time Frame

8 weeks

Title

mean change of Body Mass Index

Description

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: nurses at HCTM, 18 years and above Exclusion Criteria: pregnancy previous bariatric surgery liver cirrhosis liver cancer steatogenic drugs

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Khairul Najmi M Nawawi

Phone

+60391455555

khairulnajmi84@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Khairul Najmi M Nawawi

Organizational Affiliation

Gastroenterology Unit, Department of Medicine, Faculty of Medicine, UKM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Canselor Tuanku Muhriz

City

Cheras

State/Province

Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Khairul Najmi M Nawawi

Phone

+60391455555

Ext

5555

khairulnajmi84@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

undecided

Learn more about this trial

Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

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