MEDFAST-study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sint Franciscus Vlietland Groep Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2025-01-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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).

Secondary objectives 9

1. To compare the effect of the intervention and control group on liver steatosis during six months in adults with one or more cardiometabolic risk factors
2. To determine the difference in weight loss and body composition between the intervention and control group after six months
3. To determine the difference in cardiovascular risk factors between the intervention and control group after six months
4. To determine the difference in blood biomarkers associated with MASLD between the intervention and control group after six months
5. To evaluate the difference in lifestyle factors between the two groups
6. To evaluate the difference in quality of life between the two groups
7. To evaluate the difference in treatment satisfaction between the two groups
8. To evaluate the difference in compliance and adherence between the two groups
9. To study the associations between patient characteristics and the effectivity of the two groups

Conditions and MedDRA coding

People with a Body Mass Index (BMI) of 30 kg/m2 or more (obese), or 27 kg/m2 to 30 kg/m2 in the presence of one or more weight-related comorbidities (e.g. type 2 diabetes, dislipidaemia or regulated hypertension)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. BMI > 27 kg/m2 and at least one cardiometabolic risk factor (type 2 diabetes, hypertension, dyslipidaemia) or BMI > 30
2. Moderate to severe liver fibrosis (LSM >7.0 kPa and <13.6 kPa)
3. Aged 18-75 years
4. Written informed consent

Exclusion criteria 13

1. An insufficient comprehension of the Dutch language (spoken and written)
2. Female who is pregnant, breast-feeding or intends to become pregnant
3. 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
4. History of liver transplant, or current placement on a liver transplant list
5. History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding
6. Participants with active HIV infection and/or treatment
7. Participants with diagnosed malignancies with or without active treatment
8. Participants with history or pre-existing renal disease (eGFR <30 mL/min/1.73 m2)
9. Participants with corticosteroid induced diabetes (while still using corticosteroids)
10. Participants using GLP-1 agonists for less than 3 months or not yet on a stable dose
11. 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)
12. 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
13. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Between-group difference in liver fibrosis during six months. Liver fibrosis will be measured as liver stiffness (kPa) by transient elastography (TE) (FibroScan®)

Secondary endpoints 9

1. Liver steatosis (CAP score, FibroScan)
2. Nutritional assessment: Body weight (kg), height (cm), waist circumference (cm), fat mass and lean body mass measured with bioelectrical impedance analysis (kg), grip strength (kg)
3. Cardiovascular risk factors: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, apolipoprotein B (ApoB), apolipoprotein AI (ApoAI), lipoprotein (a), HbA1c, fasting blood glucose, fasting insulin and blood pressure, measured with routine lab procedures
4. Other laboratory measurements, measured with routine lab procedures. Among others the following routine measurements will be done: creatinine, estimated GFR (eGFR), alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), thrombocytes, haemoglobin (Hb), leukocytes, transferrin and ferritin, total iron binding capacity, apolipoprotein B48 (ApoB48), fibroblast growth factor 19 (FGF19) and 21 (FGF21), C-reactive protein (CRP), fibrosis-4 index score (Fib-4)
5. Physical activity
6. Quality of life
7. Patient satisfaction
8. Food intake and adherence to the dietary intervention
9. Demographic variables, drug use, smoking and drinking habits, (diabetes) medication use and compliance to the time restriction

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Franciscus Vlietland Groep Stichting

Sponsor organisation

Sint Franciscus Vlietland Groep Stichting

Address

Kleiweg 500

City

Rotterdam

Postcode

3045 PM

Country

Netherlands

Scientific contact point

Organisation

Sint Franciscus Vlietland Groep Stichting

Contact name

Carmen Dietvorst

Public contact point

Organisation

Sint Franciscus Vlietland Groep Stichting

Contact name

Carmen Dietvorst

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications