Prevalence of MAFLD Among Nurses and the Role of Intermittent Fasting

NCT ID: NCT05880316

Last Updated: 2023-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-28

Study Completion Date

2023-08-31

Brief Summary

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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

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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).

Conditions

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Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intermittent Fasting

Intervention Type BEHAVIORAL

3:4 regime

Non-Fasting Group

Usual care. Not allowed to fast

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intermittent Fasting

3:4 regime

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* nurses at HCTM, 18 years and above

Exclusion Criteria

* pregnancy
* previous bariatric surgery
* liver cirrhosis
* liver cancer
* steatogenic drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role lead

Responsible Party

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Khairul Najmi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khairul Najmi M Nawawi

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Khairul Najmi M Nawawi

Role: CONTACT

+60391455555

Facility Contacts

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Khairul Najmi M Nawawi

Role: primary

+60391455555 ext. 5555

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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