Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

May 19, 2023 updated by: Khairul Najmi, Universiti Kebangsaan Malaysia Medical Centre

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Hospital Canselor Tuanku Muhriz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • nurses at HCTM, 18 years and above

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change of controlled attenuated parameter (CAP) (dB/m)
Time Frame: 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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change of hepatic fibrosis score (kPa)
Time Frame: 8 weeks
measured by transient elastography (Fibroscan). The higher the value, the more severe the degree of fibrosis. Range of score: 1-25 kPa
8 weeks
Mean change of steatotest, actitest, and fibrotest scores
Time Frame: 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
8 weeks
mean change of Body Mass Index
Time Frame: 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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 28, 2023

Primary Completion (Estimated)

June 30, 2023

Study Completion (Estimated)

August 31, 2023

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKM/PPI/111/8/JEP-2023-276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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