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New treatment option for Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
Official title Time-restricted Feeding in MASLD
ClinicalTrials.gov ID: NCT07530809
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
- Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, systemic corticosteroids, methotrexate, tetracyclines, oestrogens, valproic...
- 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
See the full eligibility criteria
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Homburg, Saarland, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homburg, Saarland, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.