NCT05880316

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

May 28, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

May 10, 2023

Last Update Submit

May 19, 2023

Conditions

Fatty Liver Disease

Keywords

fatty liverMAFLDintermittent fastingtransient elastographyfibroscan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Mean change of hepatic fibrosis score (kPa)

    8 weeks

  • Mean change of steatotest, actitest, and fibrotest scores

    8 weeks

  • mean change of Body Mass Index

    8 weeks

Study Arms (2)

Intermittent Fasting Group

EXPERIMENTAL

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

Non-Fasting Group

NO INTERVENTION

Usual care. Not allowed to fast

Interventions

Intermittent FastingBEHAVIORAL

3:4 regime

Intermittent Fasting Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • nurses at HCTM, 18 years and above

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFatty LiverIntermittent Fasting

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFastingFeeding BehaviorBehavior

Study Officials

  • Khairul Najmi M Nawawi

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khairul Najmi M Nawawi

CONTACT

+60391455555khairulnajmi84@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 30, 2023

Study Start

May 28, 2023

Primary Completion

June 30, 2023

Study Completion

August 31, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

undecided

Locations

MY(1)