Diabetes Mellitus, Type 2Phase 4MEDFASTNCT06845345
Effect of an Early Time Restricted Eating Mediterranean Diet Compared to Naltrexone/Bupropion on Liver Fibrosis in People With Cardiometabolic Risk Factors in a Hospital Outpatient Clinic (MEDFAST-study)
A Phase 4 study testing early time restricted Mediterranean diet and Mysimba in people with Diabetes Mellitus, Type 2 and Liver Fibrosis, run by Carmen Dietvorst at 1 site in Netherlands.
Trial summary
In the Netherlands, there are many people with cardiometabolic diseases. More than half of these people also have fatty liver. This is a build-up of fat in the liver (steatosis) and can lead to long-term scarring (fibrosis) and even death of the liver. Losing weight can help reduce this. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Liver Fibrosis, Liver Steatoses
- What is being tested?
- early time restricted Mediterranean diet and Mysimba
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Apr 2025to Jul 2027
- Phase
- Phase 4
- 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
- BMI > 30 kg/m2 or BMI > 27 kg/m2 and at least one cardiometabolic risk factor (T2D, hypertension, dyslipidaemia)
- Moderate to severe liver fibrosis, measured as liver stiffness by transient elastography (LSM > 7.0 kPa and < 13.6 kPa)
- Aged 18-75 years
- Written informed consent
Who cannot join
- An insufficient comprehension of the Dutch language (spoken and written)
- 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
Show all 14Show fewer
- 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)
- Participants using GLP-1 agonists for less than 3 months or not yet on a stable dose
- Participants using MAO-inhibitors, opioids and/or methadone (due to contraindication)
- Known or suspected excessive alcohol consumption (>30 grams/day for males or >20 grams/day 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Mediterranean Diet Combined With Intermittent Fasting on Liver Fibrosis Compared to Naltrexone/Bupropion in People With Cardiometabolic Risk Factors
In the Netherlands, there are many people with cardiometabolic diseases. More than half of these people also have fatty liver. This is a build-up of fat in the liver (steatosis) and can lead to long-term scarring (fibrosis) and even death of the liver. Losing weight can help reduce this. Losing weight can be done with medication such as naltrexone/bupropion, which is often prescribed to people with cardiometabolic diseases, but losing weight can also be done with diet. In this study, the investigators want to combine a Mediterranean diet (with lots of vegetables, fruits, whole grain products, nuts and olive oil) with intermittent fasting. In addition participants are not allowed to eat after the evening meal. The investigators will compare this with a group of participants receiving naltrexone/bupropion, to see if a diet with intermittent fasting might be better for reducing liver steatosis and fibrosis in people with cardiometabolic diseases.
- Conditions
- Diabetes Mellitus, Type 2, Liver Fibrosis, Liver Steatoses, Hepatic Steatosis, Hepatic Fibrosis, Overweight or Obesity
- Being tested
- early time restricted Mediterranean diet, Mysimba
- Keywords
- diabetes, liver diseases, liver fibrosis, intermittent fasting, mediterranean diet, mysimba, lifestyle, cardiometabolic diseases, obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Liver Cirrhosis, Fatty Liver, Overweight, Obesity, Hypertension, Dyslipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early time restricted Mediterranean dietOther
Also called early time restricted eating, mediterranean diet, intermittent fasting, dietary intervention
Participants will start with a calorie restricted Mediterranean diet, with an eating window between 8AM till 6PM (early time-restricted eating) for a period of six months. Participants are asked to stop eating at 6PM. This results in a daily fasting window of approximately 14 hours. A daily calorie restriction of 500 kcal will be applied, based on the estimated energy requirement calculated using the WHO equation for participants with a BMI ≤ 30 and the Harris-Benedict equation for those with a BMI > 30.
MysimbaDrug
Also called naltrexone/bupropion, pharmacological intervention
Participants will take Mysimba twice daily at a total dose of 32 mg/360 mg naltrexone/bupropion per day for a duration of six months. The dosage will be built up in the first month following the stepped care approach used in the Summary of Product Characteristics (SmPC), up to maximally tolerated doses. Compliance with N/B intake is monitored by pill counting at the three and six-month visits. Participants receive usual care, including the advice of 60 minutes of exercise per day and standard dietary recommendations according to the guidelines for the Dutch population.
| Study group | Role | What they receive |
|---|---|---|
| Dietary arm | Active comparator | Calorie restricted Mediterranean diet, with an eating window between 8AM till 6PM (early time-restricted eating) Receives: Other: early time restricted Mediterranean diet |
| Pharmacological arm | Active comparator | 32 mg/360 mg naltrexone/bupropion (Mysimba) Receives: Drug: Mysimba |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in absolute change in liver fibrosis during six months
Measured as liver stiffness in kilopascals (kPa) by transient elastography with FibroScan. For a value between 0 and 8 kPa, no liver fibrosis is assumed. Anything above 8 kPa means liver fibrosis. The highest possible result is 75 kPa.
Measured: Change from baseline to 6 months
Secondary outcomes (16)
Between group difference in absoulte change in liver steatosis during six months
Measured as Controlled Attenuation Parameter (CAP) score with FibroScan. This score will range from 100 to 400 decibels per meter (dB/m). A score below 238 dB/m means the amount of fatty change in the liver is not higher than normal.
Measured: Change from baseline to 6 months
Between-group difference in weight during six months
Measured in kilograms (kg) with Seca 888 compact digital flat scale. Along with height, BMI is calculated by dividing weight by height squared. BMI should be at least 27 kg/m^2.
Measured: Change from baseline to 6 months
Between-group difference in height during six months
Measured in centimeters (cm) with a yardstick. Along with weight, BMI is calculated by dividing weight by height squared. BMI should be at least 27 kg/m^2.
Measured: Change from baseline to 6 months
Between-group difference in waist circumference during six months
Measured in centimeters (cm) with measuring tape. A healthy waist circumference for women is between 68 and 80 cm and for men between 79 and 94 cm.
Measured: Change from baseline to 6 months
Between-group difference in body composition during six months
Impedance, resistance and reactance are measured in Ohm at 50 kHz with bioelectrical impedance analysis (Bodystat 500). The impedance measuring range is between 20 and 1300 Ohm.
Measured: Change from baseline to 6 months
Between-group difference in grip strength during six months
Measured in kilograms (kg) with a hand dynamometer (Jamar). The grip strength can be measured between 0 and 90 kg. Normal values depend on gender and age. In people aged 20-29, the average grip strength is 46 kg for men and 29 kg for women.
Measured: Change from baseline to 6 months
Between-group difference in glycaemic regulation during six months
Glycaemic regulation is determined from values measured in the blood. These include fasting blood glucose measured in millimoles per litre (mmol/l), haemoglobin A1c (HbA1c) measured in millimoles per mole (mmol/mol) and fasting insulin measured in milligrams per decilitre (mg/dl). Normal values are below 6.1 mmol/l for fasting glucose, below 53 mmol/mol for HbA1c and between 60-110 mg/dl for fasting insulin.
Measured: Change from baseline to 6 months
Between-group differences in cholesterol during six months
Total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides are measured in millimoles per litre (mmol/l) through blood samples. Normal values are <5.0 mmol/l for total cholesterol, <2.6 for LDL cholesterol, >0.8 for HDL cholesterol and <2.0 for triglycerides
Measured: Change from baseline to 6 months
Between-group differences in lipoproteins during six months
Apolipoprotein B (ApoB), apolipoprotein AI (ApoAI), lipoprotein a (Lp(a)) and Apolipoproteïne B48 are measured in grams per litre (g/l) through blood samples. Normal values are: ApoB 0.55-1.4 g/l for men and 0.55-1.25 g/l for women; ApoAI 1.1-2.05 g/l for men and 1.25-2.15 g/l for women; Lp(a) <0.5 g/l. There are no normal values for Apolipoprotein B48 yet.
Measured: Change from baseline to 6 months
Between-group difference in blood pressure during six months
Systolic and diastolic blood pressure measured in millimetres of mercury pressure (mmHg). Normal values are 120-140 mmHg for systolic pressure and <90 mmHg for diastolic pressure.
Measured: Change from baseline to 6 months
Between-group difference in liver enzymes during six months
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are measured in units per litre (U/L). Normal values are <50 U/L for men and <35 U/L for women for ALT and <40 U/L for men and <32 U/L for women for AST.
Measured: Change from baseline to 6 months
Between-group difference in renal function during six months
Renal function is determined by measuring creatinine in micromol per litre (µmol/L) and eGFR in mL/min/1.73m^2. Normal values are 62-106 µmol/L for men and 44-80 µmol/L for women for creatinine; >90 mL/min/1.73m^2 for eGFR.
Measured: Change from baseline to 6 months
Between-group difference in blood count during six months
Blood count is determined by thrombocytes and leukocytes in x10⁹/L. Normal values are 150-400 x10⁹/L for thrombocytes and 4.0-10.0 x10⁹/L for leukocytes.
Measured: Change from baseline to 6 months
Between-group difference in physical activity during six months
Physical activity will be measured with Activ8 Activity Tracker GEN2. Activity is measured in time (seconds), Metabolic equivalent (MET) and kilocalories (kcal). All for sitting, standing, walking, cycling, running and total/average. In addition, step count is also measured.
Measured: Change from baseline to 6 months
Between-group difference in lifestyle factors during six months
Food intake, demographic variables, drug use, smoking and drinking habits, (diabetes) medication use and compliance to the time restriction will be administered with a self-developed questionnaire
Measured: Change from baseline to 6 months
Between-group difference in quality of life during six months
Measured with SF-36 Questionnaire. This is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a total higher score defining a more favorable health state.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start14 Apr 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmen Dietvorst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carmen Dietvorst, Franciscus Gasthuis
- Investigators
- Manuel Castro Cabezas, Dr., Principal investigator, Franciscus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845345
- Sponsor's protocol ID
- 2024-519774-40-00
- Other IDs
- 2024-519774-40-00
- Acronym
- MEDFAST
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All individual data will be encrypted and shared only with the research team.
Publications
Dietvorst CAW, Konings LAM, Saidi AN, Noordermeer T, van Wenum M, Peeters RP, Berk KA, Castro Cabezas M. Effect of an early time restricted eating Mediterranean diet compared to naltrexone/bupropion on liver fibrosis in people with cardiometabolic risk factors in a hospital outpatient clinic: study protocol for a randomised controlled trial (MEDFAST trial). BMJ Open. 2026 Jun 25;16(6):e113058. doi: 10.1136/bmjopen-2025-113058.
PubMed 42350004
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mediterranean Diet Combined With Intermittent Fasting on Liver Fibrosis Compared to Naltrexone/Bupropion in People With Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT06845345
- Acronym / sponsor ID
- MEDFAST / 2024-519774-40-00
- Conditions
- Diabetes Mellitus, Type 2, Liver Fibrosis, Liver Steatoses, Hepatic Steatosis, Hepatic Fibrosis, Overweight or Obesity
- Keywords
- diabetes, liver diseases, liver fibrosis, intermittent fasting, mediterranean diet, mysimba, lifestyle, cardiometabolic diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Carmen DietvorstUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Feb 2025 (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.
In the Netherlands, there are many people with cardiometabolic diseases. More than half of these people also have fatty liver. This is a build-up of fat in the liver (steatosis) and can lead to long-term scarring (fibrosis) and even death of the liver. Losing weight can help reduce this. Losing weight can be done with medication such as naltrexone/bupropion, which is often prescribed to people with cardiometabolic diseases, but losing weight can also be done with diet. In this study, the investigators want to combine a Mediterranean diet (with lots of vegetables, fruits, whole grain products, nuts and olive oil) with intermittent fasting. In addition participants are not allowed to eat after the evening meal. The investigators will compare this with a group of participants receiving naltrexone/bupropion, to see if a diet with intermittent fasting might be better for reducing liver steatosis and fibrosis in people with cardiometabolic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary arm | Active comparator | Other: early time restricted Mediterranean dietCalorie restricted Mediterranean diet, with an eating window between 8AM till 6PM (early time-restricted eating) |
| Pharmacological arm | Active comparator | Drug: Mysimba32 mg/360 mg naltrexone/bupropion (Mysimba) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI > 30 kg/m2 or BMI > 27 kg/m2 and at least one cardiometabolic risk factor (T2D, hypertension, dyslipidaemia)
- Moderate to severe liver fibrosis, measured as liver stiffness by transient elastography (LSM > 7.0 kPa and < 13.6 kPa)
- Aged 18-75 years
- Written informed consent
Key exclusion criteria (14 listed)
- An insufficient comprehension of the Dutch language (spoken and written)
- 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
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 |
|---|---|---|
| early time restricted Mediterranean dietAlso: early time restricted eating, mediterranean diet, intermittent fasting, dietary interventionParticipants will start with a calorie restricted Mediterranean diet, with an eating window between 8AM till 6PM (early time-restricted eating) for a period of six months. Participants are asked to stop eating at 6PM. This results in a daily fasting window of approximately 14 hours. A daily calorie restriction of 500 kcal will be applied, based on the estimated energy requirement calculated using the WHO equation for participants with a BMI ≤ 30 and the Harris-Benedict equation for those with a BMI > 30. | Other | Dietary arm |
| MysimbaAlso: naltrexone/bupropion, pharmacological interventionParticipants will take Mysimba twice daily at a total dose of 32 mg/360 mg naltrexone/bupropion per day for a duration of six months. The dosage will be built up in the first month following the stepped care approach used in the Summary of Product Characteristics (SmPC), up to maximally tolerated doses. Compliance with N/B intake is monitored by pill counting at the three and six-month visits. Participants receive usual care, including the advice of 60 minutes of exercise per day and standard dietary recommendations according to the guidelines for the Dutch population. | Drug | Pharmacological arm |
Primary outcome
Between-group difference in absolute change in liver fibrosis during six months
Time frame: Change from baseline to 6 months
Measured as liver stiffness in kilopascals (kPa) by transient elastography with FibroScan. For a value between 0 and 8 kPa, no liver fibrosis is assumed. Anything above 8 kPa means liver fibrosis. The highest possible result is 75 kPa.
16 secondary outcomes
Between group difference in absoulte change in liver steatosis during six months
Time frame: Change from baseline to 6 months
Between-group difference in weight during six months
Time frame: Change from baseline to 6 months
Between-group difference in height during six months
Time frame: Change from baseline to 6 months
Between-group difference in waist circumference during six months
Time frame: Change from baseline to 6 months
Between-group difference in body composition during six months
Time frame: Change from baseline to 6 months
Between-group difference in grip strength during six months
Time frame: Change from baseline to 6 months
Between-group difference in glycaemic regulation during six months
Time frame: Change from baseline to 6 months
Between-group differences in cholesterol during six months
Time frame: Change from baseline to 6 months
Between-group differences in lipoproteins during six months
Time frame: Change from baseline to 6 months
Between-group difference in blood pressure during six months
Time frame: Change from baseline to 6 months
Between-group difference in liver enzymes during six months
Time frame: Change from baseline to 6 months
Between-group difference in renal function during six months
Time frame: Change from baseline to 6 months
Between-group difference in blood count during six months
Time frame: Change from baseline to 6 months
Between-group difference in physical activity during six months
Time frame: Change from baseline to 6 months
Between-group difference in lifestyle factors during six months
Time frame: Change from baseline to 6 months
Between-group difference in quality of life during six months
Time frame: Change from baseline to 6 months
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 21 Apr 2026.
- Derived from this study: PubMed 42350004Dietvorst CAW, Konings LAM, Saidi AN, Noordermeer T, van Wenum M, Peeters RP, Berk KA, Castro Cabezas M. Effect of an early time restricted eating Mediterranean diet compared to naltrexone/bupropion on liver fibrosis in people with cardiometabolic risk factors in a hospital outpatient clinic: study protocol for a randomised controlled trial (MEDFAST trial). BMJ Open. 2026 Jun 25;16(6):e113058. doi: 10.1136/bmjopen-2025-113058.
- Individual participant dataSharing planned: No. All individual data will be encrypted and shared only with the research team.
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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.
Manuel Castro Cabezas, Dr. principal investigator
Franciscus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing early time restricted Mediterranean diet and Mysimba in people with Diabetes Mellitus, Type 2 and Liver Fibrosis, run by Carmen Dietvorst at 1 site in Netherlands.
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 4 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 21 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Between-group difference in absolute change in liver fibrosis during six months (time frame: Change from baseline to 6 months). 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 NCT06845345, which also lists 1 linked publication.
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 21 Apr 2026.