Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)MASLD-IntervalNCT07530809
Time-restricted Feeding in MASLD
A study testing time-restricted feeding in a 5:2 regimen in people with Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD), run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The recommended treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) currently focuses on lifestyle changes, including dietary adjustments and increased physical activity. Intermittent fasting is a specific dietary approach in which food intake is restricted for certain periods. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
- What is being tested?
- time-restricted feeding in a 5:2 regimen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2025to 15 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and 75 years
- Body mass index (BMI) > 25 kg/m²
- MASLD grade 3 with CAP ≥ 280 dB/m, excluding liver damage
- Liver stiffness < 13 kPa
- Ability to understand the study and the individual consequences of participating in the study
- Signed and dated consent form before the start of any study activity
Who cannot join
- Hepatocellular carcinoma or non-curatively treated carcinomas
- Alcohol consumption >20 g (women) and >30 g (men) per day
- Other liver diseases (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, hereditary haemochromatosis, Wilson's disease, α-1-antitrypsin deficiency
- Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, systemic corticosteroids, methotrexate, tetracyclines, oestrogens, valproic acid)
- Body weight changes of > 5% in the last 6 months
- Statins and/or other lipid-lowering drugs, if these have not been taken in a stable dose for at least 4 weeks
Show all 12Show fewer
- Uncontrolled type 2 diabetes defined as HbA1c value > 9.0% or insulin-dependent type 2 diabetes
- Pregnancy
- Immunological or inflammatory diseases (e.g. systemic lupus erythematosus)
- Following a restrictive, special diet
- Patients who have undergone organ transplants
- Lack of or absence of capacity to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Internal Medicine II, Saarland University Medical Center, Saarland University,
Homburg, Saarland, 66424
Ute M Stern, +49 6841 16 15863, ute.stern@uni-saarland.de
Maurice Michel, Dr.
About this study
Official title: The Impact of Time-restricted Feeding on Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
The recommended treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) currently focuses on lifestyle changes, including dietary adjustments and increased physical activity. Intermittent fasting is a specific dietary approach in which food intake is restricted for certain periods. Recent scientific evidence suggests that intermittent fasting can positively influence body weight, insulin resistance, and markers of inflammation.
This study will examine whether restricting energy intake to approximately 600 kcal on two days per week has beneficial effects on MASLD. The nutritional framework is based on the guidelines of the German Nutrition Society (DGE) for a healthy diet (10 rules for healthy eating). Following a two-week introduction to these DGE recommendations, participants will be randomly assigned to one of two treatment groups.
In the intervention group, participants follow a 5:2 intermittent fasting regimen, eating without restrictions on five days per week and limiting intake to about one-quarter of their usual daily energy (≈600 kcal) on two non-consecutive days. In the control group, participants follow a healthy diet according to DGE guidelines without restrictions on timing or energy intake.
- Being tested
- time-restricted feeding in a 5:2 regimen
- Keywords
- time-restricted feeding, intermittend fasting, 5:2 fasting, steatotic liver disease, MASLD, liver health, dietary intervention, nutrition, lifestyle intervention
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time-restricted feeding in a 5:2 regimenBehavioural
Participants in the intervention group follow a 5:2 intermittent fasting regimen, consisting of two non-consecutive days per week with a reduced energy intake of approximately 600 kcal, while on the remaining five days they adhere to a balanced diet in accordance with the recommendations of the German Nutrition Society (DGE).
| Study group | Role | What they receive |
|---|---|---|
| 5:2 fasting | Experimental | Participants in this arm are advised to follow a 5:2 intermittent fasting regimen. On two non-consecutive days per week, their energy intake is restricted to a maximum of one-quarter of their individual requirements (approximately 500-600 kcal). On these fasting days, participants are encouraged to consume only breakfast and then fast until the following morning. On the remaining five days, they are advised to follow a healthy, balanced diet in line with the recommendations of the German Nutrition Society (DGE), without specific (caloric) restrictions. Receives: Behavioral: time-restricted feeding in a 5:2 regimen |
| control group | No intervention | The control group follows a balanced diet without fasting, based on the DGE guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of controlled attenuation parameter (CAP)
The Controlled Attenuation Parameter (CAP) is a non-invasive ultrasound-based measure obtained during transient elastography (FibroScan®). CAP quantifies the attenuation of ultrasound signals as they pass through the liver, which correlates with the degree of hepatic steatosis. It is expressed in decibels per meter (dB/m). In patients with metabolic dysfunction-associated steatotic liver disease (MASLD), CAP is widely used to assess and grade liver fat content. Higher CAP values reflect greater hepatic fat accumulation. An improvement is defined as a reduction in CAP value of at least 20 dB/m compared to the baseline value
Measured: from enrollment to the end of treatment at 12 weeks
Secondary outcomes (13)
Improvement in liver stiffness measurment (LSM)
Liver stiffness measurement (LSM) is a non-invasive technique used to assess hepatic fibrosis. It is most commonly performed using transient elastography (FibroScan®), which measures the velocity of a shear wave generated by a mechanical pulse through the liver tissue. The faster the wave propagates, the stiffer the liver, reflecting the degree of fibrosis. Results are expressed in kilopascals (kPa).
In patients with metabolic dysfunction-associated steatotic liver disease (MASLD), LSM provides valuable information on fibrosis stage and risk of progression to advanced liver disease, including cirrhosis.
Measured: from enrollment to the end of treatment at 12 weeks
Improvement in CLDQ-NAFLD/NASH for liver-specific quality of life
The CLDQ (Chronic Liver Disease Questionnaire) is a validated questionnaire for assessing quality of life in patients with chronic liver disease. An improvement in quality of life is defined as a significant improvement in the score on the liver-specific quality of life scale compared to the baseline value.
Measured: from enrollment to the end of treatment at 12 weeks
Change in insulin sensitivity (HOMA-IR)
Insulin sensitivity is assessed using HOMA-IR (Homeostasis Model Assessment of Insulin Resistance), an index that describes the body's resistance to insulin. An improvement is defined as a significant reduction in the HOMA-IR value compared to the baseline value.
Measured: from enrollment to the end of treatment at 12 weeks
Changes in the gut microbiome
Changes in the gut microbiome (diversity and composition of the microbial population) are investigated using microbiological analyses (e.g. 16S rRNA sequencing). A change is defined as a significant shift in the composition or diversity of the microbiome compared to the baseline value.
Measured: from enrollment to the end of treatment at 12 weeks
Reduction of skin AGE
Skin AGE (Advanced Glycation End-products) is measured as a biomarker for oxidative stress and skin ageing. A reduction in Skin AGE is defined as a significant decrease in the AGE value compared to the baseline value.
Measured: from enrollment to the end of treatment at 12 weeks
Number of participants with selected genetic variants at baseline
Genotyping will be performed at baseline for the following variants: MBOAT7, TM6SF2, PNPLA3, HSD17B13, and MTARC1. The outcome is defined as the number and proportion of participants carrying each genetic variant.
Measured: baseline
Change in proportion fo circulating immune cell subsets
Immunophenotyping will be performed to quantify circulating immune cell subsets, including Th1, Th17, regulatory T cells (Treg), CD4+ T cells, CD8+ T cells, CD16+ cells, naïve and IgA+ B cells, natural killer cells, neutrophils, and M1 and M2 macrophages.
The outcome is defined as the mean change in the proportion (%) of each immune cell subset from baseline to Week 12.
Measured: from enrollment to the end of treatment at 12 weeks
Change in fasting plasma glucose
Fasting plasma glucose will be measured in mg/dL. The outcome is defined as the mean change from baseline to week 12
Measured: From enrollment to end of treatment at 12 weeks
Change in LDL cholesterol
low-density lipoprotein (LDL) cholesterol will be measured in mg/dL. The outcome is defined as the mean change from baseline to week 12.
Measured: From enrollment to end of treatment at 12 weeks.
Change in HDL cholesterol
High-density lipoprotein (HDL) cholesterol will be measured in mg/dL. The outcome is defined as the mean change from baseline to week 12.
Measured: From enrollment to end of treatment at 12 weeks.
Change in triglycerides
Triglyceride levels will be measured in mg/dL. The outcome is defined as the mean change from baseline to week 12.
Measured: From enrollment to end of treatment at 12 weeks.
Change in blood pressure
Systolic and diastolic blood pressure will be measured in mmHg. The outcome is defined as the mean change from baseline to week 12.
Measured: From enrollment to end of treatment at 12 weeks.
Change in serum cytokine and chemokine levels
Serum levels of cytokines and chemokines, including IL-6, IL-6 receptor, IL-8, CCL2, TNF-α, and IFN-γ, will be measured.
The outcome is defined as the mean change in concentration (pg/mL) from baseline to Week 12.
Measured: From enrollment to end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start15 Oct 2025
- Primary completion15 May 2029 (estimated)
- Study completion15 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)Studies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Collaborators
- M3 Research Center, Dr. Suchira Gallage, Center for Molecular Signaling, Prof. Dr. Daniela Yildiz, Department of Internal Medicine I, University Medical Centre Mainz, Prof. Dr. Peter R. Galle und PD Dr. Christian Labenz
- Responsible party
- Principal investigator, Jörn Markus Schattenberg, Universität des Saarlandes
- Investigators
- Jörn M Schattenberg, Prof. Dr., Principal investigator, Department of Internal Medicine II, Saarland University Medical Center, Saarland University, Homburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530809
- Sponsor's protocol ID
- 100/25
- Acronym
- MASLD-Interval
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Time-restricted Feeding on Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT07530809
- Acronym / sponsor ID
- MASLD-Interval / 100/25
- Keywords
- time-restricted feeding, intermittend fasting, 5:2 fasting, steatotic liver disease, MASLD, liver health, dietary intervention, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Collaborators
- M3 Research Center, Dr. Suchira Gallage, Center for Molecular Signaling, Prof. Dr. Daniela Yildiz, Department of Internal Medicine I, University Medical Centre Mainz, Prof. Dr. Peter R. Galle und PD Dr. Christian Labenz
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 May 2029 (estimated)
- Study completion
- 15 May 2029 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The recommended treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) currently focuses on lifestyle changes, including dietary adjustments and increased physical activity. Intermittent fasting is a specific dietary approach in which food intake is restricted for certain periods. Recent scientific evidence suggests that intermittent fasting can positively influence body weight, insulin resistance, and markers of inflammation.
This study will examine whether restricting energy intake to approximately 600 kcal on two days per week has beneficial effects on MASLD. The nutritional framework is based on the guidelines of the German Nutrition Society (DGE) for a healthy diet (10 rules for healthy eating). Following a two-week introduction to these DGE recommendations, participants will be randomly assigned to one of two treatment groups.
In the intervention group, participants follow a 5:2 intermittent fasting regimen, eating without restrictions on five days per week and limiting intake to about one-quarter of their usual daily energy (≈600 kcal) on two non-consecutive days. In the control group, participants follow a healthy diet according to DGE guidelines without restrictions on timing or energy intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5:2 fasting | Experimental | Behavioral: time-restricted feeding in a 5:2 regimenParticipants in this arm are advised to follow a 5:2 intermittent fasting regimen. On two non-consecutive days per week, their energy intake is restricted to a maximum of one-quarter of their individual requirements (approximately 500-600 kcal). On these fasting days, participants are encouraged to consume only breakfast and then fast until the following morning. On the remaining five days, they are advised to follow a healthy, balanced diet in line with the recommendations of the German Nutrition Society (DGE), without specific (caloric) restrictions. |
| control group | No intervention | –The control group follows a balanced diet without fasting, based on the DGE guidelines. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 and 75 years
- Body mass index (BMI) > 25 kg/m²
- MASLD grade 3 with CAP ≥ 280 dB/m, excluding liver damage
- Liver stiffness < 13 kPa
- Ability to understand the study and the individual consequences of participating in the study
Key exclusion criteria (12 listed)
- Hepatocellular carcinoma or non-curatively treated carcinomas
- Alcohol consumption >20 g (women) and >30 g (men) per day
- Other liver diseases (HBV, HCV, HDV, HEV, HIV), autoimmune diseases or chronic cholestatic liver disease, hereditary haemochromatosis, Wilson's disease, α-1-antitrypsin deficiency
- Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, systemic corticosteroids, methotrexate, tetracyclines, oestrogens, valproic acid)
- Body weight changes of > 5% in the last 6 months
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 |
|---|---|---|
| time-restricted feeding in a 5:2 regimenParticipants in the intervention group follow a 5:2 intermittent fasting regimen, consisting of two non-consecutive days per week with a reduced energy intake of approximately 600 kcal, while on the remaining five days they adhere to a balanced diet in accordance with the recommendations of the German Nutrition Society (DGE). | Behavioural | 5:2 fasting |
Primary outcome
Reduction of controlled attenuation parameter (CAP)
Time frame: from enrollment to the end of treatment at 12 weeks
The Controlled Attenuation Parameter (CAP) is a non-invasive ultrasound-based measure obtained during transient elastography (FibroScan®). CAP quantifies the attenuation of ultrasound signals as they pass through the liver, which correlates with the degree of hepatic steatosis. It is expressed in decibels per meter (dB/m). In patients with metabolic dysfunction-associated steatotic liver disease (MASLD), CAP is widely used to assess and grade liver fat content. Higher CAP values reflect greater hepatic fat accumulation. An improvement is defined as a reduction in CAP value of at least 20 dB/m compared to the baseline value
13 secondary outcomes
Improvement in liver stiffness measurment (LSM)
Time frame: from enrollment to the end of treatment at 12 weeks
Improvement in CLDQ-NAFLD/NASH for liver-specific quality of life
Time frame: from enrollment to the end of treatment at 12 weeks
Change in insulin sensitivity (HOMA-IR)
Time frame: from enrollment to the end of treatment at 12 weeks
Changes in the gut microbiome
Time frame: from enrollment to the end of treatment at 12 weeks
Reduction of skin AGE
Time frame: from enrollment to the end of treatment at 12 weeks
Number of participants with selected genetic variants at baseline
Time frame: baseline
Change in proportion fo circulating immune cell subsets
Time frame: from enrollment to the end of treatment at 12 weeks
Change in fasting plasma glucose
Time frame: From enrollment to end of treatment at 12 weeks
Change in LDL cholesterol
Time frame: From enrollment to end of treatment at 12 weeks.
Change in HDL cholesterol
Time frame: From enrollment to end of treatment at 12 weeks.
Change in triglycerides
Time frame: From enrollment to end of treatment at 12 weeks.
Change in blood pressure
Time frame: From enrollment to end of treatment at 12 weeks.
Change in serum cytokine and chemokine levels
Time frame: From enrollment to end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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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.
Jörn M Schattenberg, Prof. Dr. principal investigator
Department of Internal Medicine II, Saarland University Medical Center, Saarland University, Homburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing time-restricted feeding in a 5:2 regimen in people with Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD), run by Universität des Saarlandes at 1 site in Germany.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ute M Stern (+ 49 6841 16 15863, ute.stern@uni-saarland.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of controlled attenuation parameter (CAP) (time frame: from enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.