Long-term effects of time-restricted eating on liver health in people with metabolic fatty liver disease

ISRCTN	ISRCTN74413912
DOI	https://doi.org/10.1186/ISRCTN74413912
Sponsor	Prince Sattam Bin Abdulaziz University
Funder	Prince Sattam bin Abdulaziz University

Submission date: 20/01/2026
Registration date: 26/01/2026
Last edited: 26/01/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Fatty liver disease related to metabolic problems such as obesity and diabetes is common and can progress to liver damage and scarring. Lifestyle changes are recommended, but it is unclear which approaches lead to sustained long-term improvements in liver function. This study aims to determine whether time-restricted eating (limiting the daily eating window) leads to long-term improvements in liver fat, liver stiffness, and metabolic health compared with other commonly used lifestyle strategies.

Who can participate?
Adults aged 18–65 years diagnosed with metabolic dysfunction–associated steatotic liver disease or metabolic dysfunction–associated steatohepatitis, without other causes of chronic liver disease.

What does the study involve?
Participants receive standard lifestyle counselling and are followed over time as part of routine clinical care. Some participants choose to follow time-restricted eating, while others follow different dietary, pharmacologic, or exercise-based approaches. Liver health, blood tests, and body measurements are assessed at baseline and during follow-up using non-invasive methods.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in metabolic health and liver-related outcomes. Risks are minimal and include temporary hunger, fatigue, or digestive symptoms related to lifestyle changes, as well as minor discomfort from routine blood sampling and non-invasive liver assessments.

Where is the study run from?
Prince Sattam Bin Abdulaziz University Hospital (Saudi Arabia)

When is the study starting, and how long is it expected to run for?
October 2021 to March 2024

Who is funding the study?
Prince Sattam bin Abdulaziz University (Saudi Arabia)

Who is the main contact?
Prof. Dr Sanaa M. Kamal, s.kamal@psau.edu.sa

Contact information

Prof Sanaa Kamal
Principal investigator

Prince Sattam University College of Medicine
Kharj
16278
Saudi Arabia

ORCID ID	0000-0002-2052-7956
Phone	+966 (0)582001876
Email	s.kamal@psau.edu.sa

Dr Mohammad Qahtani
Scientific

Prince Sattam University College of Medicine
Kharj
16278
Saudi Arabia

Phone	+966 (0)593178517
Email	qahtanims80@outlook.com

Dr Ahmed Al Badrani
Public

Prince Sattam University College of Medicine
Kharj
16278
Saudi Arabia

Phone	+966 (0)594875700
Email	ahmedthanaa952@gmail.com

Study information

Primary study design	Observational
Observational study design	Cohort study
Scientific title	Durable improvement of hepatic steatosis and fibrosis with time-restricted eating in metabolic dysfunction–associated steatotic liver disease and metabolic dysfunction–associated steatohepatitis: a long-term comparative observational study
Study objectives	The primary objective of this study is to evaluate the long-term effects of time-restricted eating implemented as intermittent fasting on hepatic steatosis and fibrosis in adults with metabolic dysfunction–associated steatotic liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH). Secondary objectives are to compare the hepatic, metabolic, and anthropometric outcomes of intermittent fasting with other commonly used real-world lifestyle strategies, including calorie-restricted diets, pharmacologic therapy with Orlistat, and exercise without dietary restriction, and to assess the durability of these effects over extended follow-up using non-invasive imaging and serum-based fibrosis markers.
Ethics approval(s)	Approved 01/03/2021, Prince Sattam Bin Abdulaziz University Review Board (Abdullah Bin Amer Street, Kharj, 16278, Saudi Arabia; +966 (0)538276418; a.m.asiri@psau.edu.sa), ref: IRB #PSAU-MED-2021/09
Health condition(s) or problem(s) studied	Metabolic dysfunction–associated steatotic liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH), hepatic steatosis, liver fibrosis, metabolic dysfunction
Methodology	This is a prospective observational cohort study. Adults with metabolic dysfunction–associated steatotic liver disease (MASLD) or metabolic dysfunction–associated steatohepatitis (MASH) were enrolled following eligibility screening and informed consent. At enrolment, participants were allocated to different lifestyle or pharmacologic management strategies as part of routine clinical care, including time-restricted eating (intermittent fasting), calorie-restricted diets, pharmacologic therapy, or exercise counselling. The study protocol mandated no intervention, and adherence was voluntary. Participants underwent baseline clinical, biochemical, and non-invasive hepatic assessments and were followed at regular intervals, with a total observation and follow-up duration of up to 48 months, after which participation ended.
Intervention type	Mixed
Primary outcome measure(s)	Hepatic steatosis measured using controlled attenuation parameter (CAP) measured by transient elastography (FibroScan®) at baseline and longitudinal follow-up up to 48 months Hepatic fibrosis measured using liver stiffness measurement (LSM) assessed by transient elastography (FibroScan®) at baseline and longitudinal follow-up up to 48 months
Key secondary outcome measure(s)	Body weight measured using standardized clinic scales at baseline and longitudinal follow-up up to 48 months Insulin resistance measured using HOMA-IR calculated from fasting glucose and fasting insulin at baseline and longitudinal follow-up up to 48 months Glycaemic control measured using fasting glucose (mg/dL) and HbA1c (%) at baseline and longitudinal follow-up up to 48 months
Completion date	10/03/2024

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	203
Total final enrolment	197
Key inclusion criteria	1. Adults aged 18–65 years 2. Diagnosis of metabolic dysfunction–associated steatotic liver disease (MASLD) or metabolic dysfunction–associated steatohepatitis (MASH) 3. Evidence of hepatic steatosis defined by: 4. Imaging (ultrasonography) and/or FibroScan® controlled attenuation parameter (CAP) ≥248 dB/m 5. Presence of at least one metabolic risk factor (e.g. overweight/obesity, type 2 diabetes, dyslipidaemia, hypertension) 6. For MASH: elevated aminotransferases with concordant FibroScan® liver stiffness measurement (LSM) ≥8 kPa 7. Ability and willingness to provide written informed consent 8. Willingness to participate in longitudinal follow-up
Key exclusion criteria	1. Chronic viral hepatitis (hepatitis B or C) 2. Autoimmune liver disease or cholestatic liver disease 3. Genetic or metabolic liver diseases (e.g. hemochromatosis, Wilson disease) 4. Drug-induced liver injury or use of known hepatotoxic medications 5. Decompensated cirrhosis or clinical evidence of portal hypertension 6. Active malignancy 7. Pregnancy or breastfeeding 8. Severe or unstable cardiovascular disease 9. Acute systemic illness at the time of enrollment 10. Significant alcohol intake 11. Inability to comply with follow-up or lifestyle intervention protocols 12. Prior bariatric surgery or planned bariatric surgery during the study period
Date of first enrolment	01/10/2021
Date of final enrolment	01/03/2022

Locations

Countries of recruitment

Egypt
India
Jordan
Philippines
Saudi Arabia
Tunisia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

26/01/2026: Study's existence confirmed by the Prince Sattam Bin Abdulaziz University Review Board.