Intermittent FastingNCT06664684

Intermittent Fasting and Metabolic Dysfunction Associated Fatty Liver Disease

A study testing Energy-restricted dietary intervention and Energy + time-restricted dietary intervention in people with Intermittent Fasting and Metabolic Dysfunction-Associated Fatty Liver Disease, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Intermittent Fasting, Metabolic Dysfunction-Associated Fatty Liver Disease
What is being tested?: Energy-restricted dietary intervention and Energy + time-restricted dietary intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 23 May 2022to 12 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Diagnosed with MAFLD
Aged 18-65 years
BMI ≥ 25 kg/m²
A stable body weight (<5 kg weight loss or gain) over the last 3 months preceding the start of the study
Signed the informed consent form.

Who cannot join

An average daily alcohol consumption >20 g for females and >30 g for males
Pregnant or lactating women
Patients with ischemic heart disease or heart failure, chronic inflammatory diseases, chronic viral infections, cancer, moderate-to-severe kidney disease, uncontrolled hypertension, and eating disorders
Those with a history of bariatric surgery
Those on insulin due to increased risk of hypoglycemia.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Institute of Gastroenterology, Liver Research Unit, Marmara University
Istanbul, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Intermittent Fasting in Metabolic Dysfunction Associated Fatty Liver Disease

Previous studies have investigated the effect of different dietary patterns on metabolic dysfunction-associated fatty liver disease (MAFLD), for which lifestyle modification remains the primary treatment. The present study sought to determine the effect of intermittent fasting on anthropometric measurements, fibroblast growth factor (FGF)-21, and autophagy markers including autophagy-related protein (ATG)-5 and BECLIN-1 levels, as well as on hepatic steatosis and fibrosis levels in overweight or obese patients with MAFLD to elucidate the efficacy of intermittent fasting in the management of MAFLD. The study included 48 patients diagnosed with MAFLD. Patients were randomly assigned into two groups: 22 received a dietary treatment involving 22-25 kcal/kg/day of energy for 8 weeks (energy-restricted diet group), and 26 followed the same dietary intervention and a 16:8 pattern (energy + time-restricted diet group). The patients were assessed for various parameters at baseline (T0) and at the end of the week 8 (T8). The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. Serum levels of FGF-21, BECLIN-1, and ATG-5 were determined using enzyme-linked immunosorbent assay.

Conditions: Intermittent Fasting, Metabolic Dysfunction-Associated Fatty Liver Disease
Being tested: Energy-restricted dietary intervention, Energy + time-restricted dietary intervention
Keywords: Intermittent fasting, fibroblast growth factor 21, autophagy, fatty liver, time-restricted eating
Medical subject headings: Intermittent Fasting, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Energy-restricted dietary interventionOther
The diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD [5-6, 27-28]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.
Energy + time-restricted dietary interventionOther
Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.

Study groups in NCT06664684
Study group	Role	What they receive
Energy-restricted diet	Active comparator	The energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight. Receives: Other: Energy-restricted dietary intervention
Energy + time-restricted diet	Experimental	Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Receives: Other: Energy + time-restricted dietary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Transient Elastography-Controlled Attenuation Parameter
The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic steatosis was defined using controlled attenuation parameter (CAP). The CAP measurement, which indicates steatosis, ranged between 100 and 400 dB/m.
Measured: Measurements were taken twice baseline and 8 weeks after the intervention.
Transient Elastography-Liver Stiffness Measurement
The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic fibrosis were defined using liver stiffness measurement (LSM). LSM measurement ranged between 2.5 and 75 kPa.
Measured: Measurements were taken twice baseline and 8 weeks after the intervention.

Secondary outcomes (3)

Serum Fibroblast Growth Factor-21
At each time point (baseline and week 8), one serum sample was collected per participant. Serum Fibroblast Growth Factor-21 (FGF-21) levels were analyzed using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's protocols (Human FGF-21 ELISA, Biovendor, Czech Republic).
Measured: Measurements were taken baseline before and 8 weeks after the intervention.
Serum Autophagy-Related Protein-5
At each time point (baseline and week 8), one serum sample was collected per participant. Serum autophagy-related protein-5 (ATG-5) were analyzed using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's protocols (Human Autophagy protein 5 [ATG5] ELISA Kit, MyBioSource, Inc. USA).
Measured: Measurements were taken twice baseline and 8 weeks after the intervention.
Serum Beclin-1
At each time point (baseline and week 8), one serum sample was collected per participant. Serum Beclin-1 were analyzed using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's protocols (Human BECN1 [Beclin 1] ELISA Kit, ElabScience, USA).
Measured: Measurements were taken twice baseline and 8 weeks after the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 202212 Sep 2023

First posted29 Oct 2024
Study start23 May 2022
Primary completion30 Jan 2023
Study completion12 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Intermittent FastingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06664684
Sponsor's protocol ID: MAFLDIF
Other IDs: 24172
Status last verified: Jun 2025
First submitted: 24 Oct 2024
Last updated: 26 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Czaja MJ. Function of Autophagy in Nonalcoholic Fatty Liver Disease. Dig Dis Sci. 2016 May;61(5):1304-13. doi: 10.1007/s10620-015-4025-x. Epub 2016 Jan 2.
PubMed 26725058
Itoh N. FGF21 as a Hepatokine, Adipokine, and Myokine in Metabolism and Diseases. Front Endocrinol (Lausanne). 2014 Jul 7;5:107. doi: 10.3389/fendo.2014.00107. eCollection 2014.
PubMed 25071723
Kleinert M, Muller TD. A New FGF21 Analog for the Treatment of Fatty Liver Disease. Diabetes. 2020 Aug;69(8):1605-1607. doi: 10.2337/dbi20-0025. No abstract available.
PubMed 32690662
Byun S, Seok S, Kim YC, Zhang Y, Yau P, Iwamori N, Xu HE, Ma J, Kemper B, Kemper JK. Fasting-induced FGF21 signaling activates hepatic autophagy and lipid degradation via JMJD3 histone demethylase. Nat Commun. 2020 Feb 10;11(1):807. doi: 10.1038/s41467-020-14384-z.
PubMed 32042044
Hydes TJ, Ravi S, Loomba R, E Gray M. Evidence-based clinical advice for nutrition and dietary weight loss strategies for the management of NAFLD and NASH. Clin Mol Hepatol. 2020 Oct;26(4):383-400. doi: 10.3350/cmh.2020.0067. Epub 2020 Jul 17.
PubMed 32674529
Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.
PubMed 32044314

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intermittent Fasting trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Intermittent Fasting in Metabolic Dysfunction Associated Fatty Liver Disease
ClinicalTrials.gov ID: NCT06664684
Acronym / sponsor ID: MAFLDIF
Conditions: Intermittent Fasting, Metabolic Dysfunction-Associated Fatty Liver Disease
Keywords: Intermittent fasting, fibroblast growth factor 21, autophagy, fatty liver, time-restricted eating
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Istanbul Bilgi UniversityUniversity, hospital or other
Collaborators: Marmara University
Study start: 23 May 2022 (actual)
Primary completion: 30 Jan 2023 (actual)
Study completion: 12 Sep 2023 (actual)
First posted: 29 Oct 2024 (actual)
Results: Posted 26 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Energy-restricted diet	Active comparator	Other: Energy-restricted dietary interventionThe energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight.
Energy + time-restricted diet	Experimental	Other: Energy + time-restricted dietary interventionPatients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosed with MAFLD
Aged 18-65 years
BMI ≥ 25 kg/m²
A stable body weight (<5 kg weight loss or gain) over the last 3 months preceding the start of the study
Signed the informed consent form.

Key exclusion criteria (5 listed)

An average daily alcohol consumption >20 g for females and >30 g for males
Pregnant or lactating women
Patients with ischemic heart disease or heart failure, chronic inflammatory diseases, chronic viral infections, cancer, moderate-to-severe kidney disease, uncontrolled hypertension, and eating disorders
Those with a history of bariatric surgery
Those on insulin due to increased risk of hypoglycemia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Energy-restricted dietary interventionThe diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD [5-6, 27-28]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.	Other	Energy-restricted diet
Energy + time-restricted dietary interventionPatients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.	Other	Energy + time-restricted diet

Primary outcome

Transient Elastography-Controlled Attenuation Parameter
Time frame: Measurements were taken twice baseline and 8 weeks after the intervention.
The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic steatosis was defined using controlled attenuation parameter (CAP). The CAP measurement, which indicates steatosis, ranged between 100 and 400 dB/m.
Transient Elastography-Liver Stiffness Measurement
Time frame: Measurements were taken twice baseline and 8 weeks after the intervention.
The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic fibrosis were defined using liver stiffness measurement (LSM). LSM measurement ranged between 2.5 and 75 kPa.

3 secondary outcomes

Serum Fibroblast Growth Factor-21
Time frame: Measurements were taken baseline before and 8 weeks after the intervention.
Serum Autophagy-Related Protein-5
Time frame: Measurements were taken twice baseline and 8 weeks after the intervention.
Serum Beclin-1
Time frame: Measurements were taken twice baseline and 8 weeks after the intervention.

Results and safety

Results posted to the registry on 26 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Energy-restricted Diet	27	22
Energy + Time-restricted Diet	28	26

Primary outcome: Transient Elastography-Controlled Attenuation Parameter

Time frame: Measurements were taken twice baseline and 8 weeks after the intervention.. Median (Inter-Quartile Range). Unit: db/m

Measure	Energy-restricted Diet n = 22	Energy + Time-restricted Diet n = 26
Baseline	319.5 (296.7 to 371.5)	343.5 (297.0 to 363.2)
8 weeks after the Intervention (End)	291.5 (254.5 to 324.2)	285.0 (268.2 to 353.7)

Population analysed: The number of participants completing the study in the groups is equal to the analysis population in the data table.

Primary outcome: Transient Elastography-Liver Stiffness Measurement

Time frame: Measurements were taken twice baseline and 8 weeks after the intervention.. Median (Inter-Quartile Range). Unit: kpa

Measure	Energy-restricted Diet n = 22	Energy + Time-restricted Diet n = 26
Baseline	5.5 (4.2 to 6.2)	5.7 (4.6 to 6.9)
8 weeks after the Intervention (End)	5.1 (4.3 to 6.3)	4.8 (3.9 to 6.5)

Population analysed: The number of participants completing the study in the groups is equal to the analysis population in the data table.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline until end of follow-up, up to 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Energy-restricted Diet	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Energy + Time-restricted Diet	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26725058Czaja MJ. Function of Autophagy in Nonalcoholic Fatty Liver Disease. Dig Dis Sci. 2016 May;61(5):1304-13. doi: 10.1007/s10620-015-4025-x. Epub 2016 Jan 2.
Results publication: PubMed 25071723Itoh N. FGF21 as a Hepatokine, Adipokine, and Myokine in Metabolism and Diseases. Front Endocrinol (Lausanne). 2014 Jul 7;5:107. doi: 10.3389/fendo.2014.00107. eCollection 2014.
Results publication: PubMed 32690662Kleinert M, Muller TD. A New FGF21 Analog for the Treatment of Fatty Liver Disease. Diabetes. 2020 Aug;69(8):1605-1607. doi: 10.2337/dbi20-0025. No abstract available.
Results publication: PubMed 32042044Byun S, Seok S, Kim YC, Zhang Y, Yau P, Iwamori N, Xu HE, Ma J, Kemper B, Kemper JK. Fasting-induced FGF21 signaling activates hepatic autophagy and lipid degradation via JMJD3 histone demethylase. Nat Commun. 2020 Feb 10;11(1):807. doi: 10.1038/s41467-020-14384-z.
Results publication: PubMed 32674529Hydes TJ, Ravi S, Loomba R, E Gray M. Evidence-based clinical advice for nutrition and dietary weight loss strategies for the management of NAFLD and NASH. Clin Mol Hepatol. 2020 Oct;26(4):383-400. doi: 10.3350/cmh.2020.0067. Epub 2020 Jul 17.
Results publication: PubMed 32044314Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transient Elastography-Controlled Attenuation Parameter (time frame: Measurements were taken twice baseline and 8 weeks after the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06664684, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025; AzTrials last refreshed its copy on 1 Nov 2026.