BridgeMD
MEDFAST-study
EU CTIS ID: 2024-519774-40-00
What this study is testing
To determine the difference in effectiveness of an early time restricted eating Mediterranean diet (eTRE-MD) during six months of intervention on improvement of liver fibrosis when compared to Mysimba in individuals with one or more cardiometabolic risk factor(s) and moderate to severe liver fibrosis (LSM >7.0 kPa by Fibroscan).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- BMI > 27 kg/m2 and at least one cardiometabolic risk factor (type 2 diabetes, hypertension, dyslipidaemia) or BMI > 30
- Moderate to severe liver fibrosis (LSM >7.0 kPa and <13.6 kPa)
- Aged 18-75 years
- Written informed consent
You likely can't join if
- An insufficient comprehension of the Dutch language (spoken and written)
- Participants using GLP-1 agonists for less than 3 months or not yet on a stable dose
- Known or suspected excessive alcohol consumption (>21 drinks/week for males or >14 drinks/week for females. One drink is equivalent to 10 grams of alcohol)
- Previous or planned (during the trial period) obesity treatment with surgery. However, previous interventions that, due to reversal or removal, do not have any influence on the patient’s weight, in the opinion of the investigator, are allowed
- Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient’s safety or ability to complete the study
- Female who is pregnant, breast-feeding or intends to become pregnant
See the full eligibility criteria
- BMI > 27 kg/m2 and at least one cardiometabolic risk factor (type 2 diabetes, hypertension, dyslipidaemia) or BMI > 30
- Moderate to severe liver fibrosis (LSM >7.0 kPa and <13.6 kPa)
- Aged 18-75 years
- Written informed consent
- An insufficient comprehension of the Dutch language (spoken and written)
- Participants using GLP-1 agonists for less than 3 months or not yet on a stable dose
- Known or suspected excessive alcohol consumption (>21 drinks/week for males or >14 drinks/week for females. One drink is equivalent to 10 grams of alcohol)
- Previous or planned (during the trial period) obesity treatment with surgery. However, previous interventions that, due to reversal or removal, do not have any influence on the patient’s weight, in the opinion of the investigator, are allowed
- Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient’s safety or ability to complete the study
- Female who is pregnant, breast-feeding or intends to become pregnant
- Participants with an established diagnosis of liver pathology like, but not limited to: Hepatitis B, Hepatitis C, Autoimmune hepatitis, Wilson’s disease, Hemochromatosis, Primary biliary cholangitis, Primary sclerosing cholangitis, Alcoholic liver disease
- History of liver transplant, or current placement on a liver transplant list
- History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding
- Participants with active HIV infection and/or treatment
- Participants with diagnosed malignancies with or without active treatment
- Participants with history or pre-existing renal disease (eGFR <30 mL/min/1.73 m2)
- Participants with corticosteroid induced diabetes (while still using corticosteroids)
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.